Trial Outcomes & Findings for A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women (NCT NCT00855335)

NCT ID: NCT00855335

Last Updated: 2018-07-06

Results Overview

C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 77 participants
• Primary outcome timeframe: Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
• Results posted on: 2018-07-06

Participant Flow

Participant milestones

Measure	Darunavir 600 mg /Ritonavir 100 mg Twice Daily Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.	Darunavir 800 mg /Ritonavir 100 mg Once Daily Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg/Cobicistat 150 mg Once Daily Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Study STARTED	18	18	15	19	7
Overall Study COMPLETED	13	16	10	12	6
Overall Study NOT COMPLETED	5	2	5	7	1

Reasons for withdrawal

Measure	Darunavir 600 mg /Ritonavir 100 mg Twice Daily Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.	Darunavir 800 mg /Ritonavir 100 mg Once Daily Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg/Cobicistat 150 mg Once Daily Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Study Lost to Follow-up	0	0	3	1	0
Overall Study Withdrawal by Subject	0	0	0	1	0
Overall Study Adverse Event	2	0	0	0	0
Overall Study Physician Decision	1	1	0	0	0
Overall Study Other	2	1	2	5	1

Baseline Characteristics

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

Baseline characteristics by cohort

Measure	Darunavir 600 mg /Ritonavir 100 mg Twice Daily n=18 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.	Darunavir 800 mg /Ritonavir 100 mg Once Daily n=18 Participants Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=15 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=19 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg/Cobicistat 150 mg Once Daily n=7 Participants Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Total n=77 Participants Total of all reporting groups
Age, Continuous	25.7 years STANDARD_DEVIATION 5.6 • n=5 Participants	24.2 years STANDARD_DEVIATION 3.45 • n=7 Participants	26.3 years STANDARD_DEVIATION 4.91 • n=5 Participants	27.2 years STANDARD_DEVIATION 4.51 • n=4 Participants	28.86 years STANDARD_DEVIATION 4.71 • n=21 Participants	26.1 years STANDARD_DEVIATION 4.75 • n=10 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants	7 Participants n=21 Participants	77 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	18 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants	7 Participants n=21 Participants	77 Participants n=10 Participants

PRIMARY outcome

Timeframe: Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=13 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=13 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=15 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Predose (Trough) Plasma Concentration (C0h) Postpartum (6-12 W)	3608 nanogram per milliliter (ng/mL) Standard Deviation 2812	491.4 nanogram per milliliter (ng/mL) Standard Deviation 472.4	2481 nanogram per milliliter (ng/mL) Standard Deviation 2183	147 nanogram per milliliter (ng/mL) Standard Deviation 198	281 nanogram per milliliter (ng/mL) Standard Deviation 193	127 nanogram per milliliter (ng/mL) Standard Deviation 97.0	2811 nanogram per milliliter (ng/mL) Standard Deviation 2296	134 nanogram per milliliter (ng/mL) Standard Deviation 145
Predose (Trough) Plasma Concentration (C0h) 2nd Trimester	2323 nanogram per milliliter (ng/mL) Standard Deviation 1140	225.9 nanogram per milliliter (ng/mL) Standard Deviation 127.5	1793 nanogram per milliliter (ng/mL) Standard Deviation 964	94.2 nanogram per milliliter (ng/mL) Standard Deviation 102	439 nanogram per milliliter (ng/mL) Standard Deviation 212	75.6 nanogram per milliliter (ng/mL) Standard Deviation 36.2	540 nanogram per milliliter (ng/mL) Standard Deviation 803	NA nanogram per milliliter (ng/mL) Standard Deviation NA Here, NA indicates that the data is not reported because the predose plasma concentrations were Below Quantification Limit (BQL) less than (\<) 5.00 ng/mL.
Predose (Trough) Plasma Concentration (C0h) 3rd Trimester	3280 nanogram per milliliter (ng/mL) Standard Deviation 1466	236.0 nanogram per milliliter (ng/mL) Standard Deviation 108.08	1528 nanogram per milliliter (ng/mL) Standard Deviation 1184	74.6 nanogram per milliliter (ng/mL) Standard Deviation 90.2	413 nanogram per milliliter (ng/mL) Standard Deviation 78.2	78.0 nanogram per milliliter (ng/mL) Standard Deviation 39.1	824 nanogram per milliliter (ng/mL) Standard Deviation 630	30.1 nanogram per milliliter (ng/mL) Standard Deviation 51.5

PRIMARY outcome

Timeframe: Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The Cmin is the minimum observed plasma concentration.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=13 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=13 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=15 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Minimum Plasma Concentration (Cmin) Postpartum (6-12 W)	2851 nanogram per milliliter (ng/mL) Standard Deviation 2216	264.7 nanogram per milliliter (ng/mL) Standard Deviation 259.8	1473 nanogram per milliliter (ng/mL) Standard Deviation 1141	40.5 nanogram per milliliter (ng/mL) Standard Deviation 31.4	269 nanogram per milliliter (ng/mL) Standard Deviation 182	84.0 nanogram per milliliter (ng/mL) Standard Deviation 58.8	1538 nanogram per milliliter (ng/mL) Standard Deviation 1344	41.4 nanogram per milliliter (ng/mL) Standard Deviation 49.1
Minimum Plasma Concentration (Cmin) 2nd Trimester	1922 nanogram per milliliter (ng/mL) Standard Deviation 825	141.1 nanogram per milliliter (ng/mL) Standard Deviation 73.78	1248 nanogram per milliliter (ng/mL) Standard Deviation 542	32.2 nanogram per milliliter (ng/mL) Standard Deviation 19.8	383 nanogram per milliliter (ng/mL) Standard Deviation 210	54.3 nanogram per milliliter (ng/mL) Standard Deviation 25.8	168 nanogram per milliliter (ng/mL) Standard Deviation 149	NA nanogram per milliliter (ng/mL) Standard Deviation NA Here, NA indicates that the data is not reported because the plasma concentrations were BQL (\< 5.00 ng/mL).
Minimum Plasma Concentration (Cmin) 3rd Trimester	2661 nanogram per milliliter (ng/mL) Standard Deviation 1269	148.1 nanogram per milliliter (ng/mL) Standard Deviation 52.26	1075 nanogram per milliliter (ng/mL) Standard Deviation 594	28.0 nanogram per milliliter (ng/mL) Standard Deviation 20.5	349 nanogram per milliliter (ng/mL) Standard Deviation 103	52.9 nanogram per milliliter (ng/mL) Standard Deviation 24.4	184 nanogram per milliliter (ng/mL) Standard Deviation 99.0	NA nanogram per milliliter (ng/mL) Standard Deviation NA Here, NA indicates that the data is not reported because the plasma concentrations were BQL (\< 5.00 ng/mL).

PRIMARY outcome

Timeframe: Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The Cmax is the maximum observed plasma concentration.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=13 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=13 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=15 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Maximum Plasma Concentration (Cmax) Postpartum (6-12 W)	6659 nanogram per milliliter (ng/mL) Standard Deviation 2364	1110 nanogram per milliliter (ng/mL) Standard Deviation 901.2	7310 nanogram per milliliter (ng/mL) Standard Deviation 1704	742 nanogram per milliliter (ng/mL) Standard Deviation 335	569 nanogram per milliliter (ng/mL) Standard Deviation 261	167 nanogram per milliliter (ng/mL) Standard Deviation 101	7918 nanogram per milliliter (ng/mL) Standard Deviation 2199	996 nanogram per milliliter (ng/mL) Standard Deviation 323
Maximum Plasma Concentration (Cmax) 2nd Trimester	4668 nanogram per milliliter (ng/mL) Standard Deviation 1097	546.8 nanogram per milliliter (ng/mL) Standard Deviation 249.4	4964 nanogram per milliliter (ng/mL) Standard Deviation 1505	439 nanogram per milliliter (ng/mL) Standard Deviation 241	774 nanogram per milliliter (ng/mL) Standard Deviation 300	121 nanogram per milliliter (ng/mL) Standard Deviation 45.9	4340 nanogram per milliliter (ng/mL) Standard Deviation 1616	571 nanogram per milliliter (ng/mL) Standard Deviation 350
Maximum Plasma Concentration (Cmax) 3rd Trimester	5328 nanogram per milliliter (ng/mL) Standard Deviation 1631	536.1 nanogram per milliliter (ng/mL) Standard Deviation 210.6	5132 nanogram per milliliter (ng/mL) Standard Deviation 1198	397 nanogram per milliliter (ng/mL) Standard Deviation 184	785 nanogram per milliliter (ng/mL) Standard Deviation 238	123 nanogram per milliliter (ng/mL) Standard Deviation 47.5	4910 nanogram per milliliter (ng/mL) Standard Deviation 970	759 nanogram per milliliter (ng/mL) Standard Deviation 366

PRIMARY outcome

Timeframe: Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=13 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=17 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=13 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=15 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=7 Participants Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Time to Reach the Maximum Plasma Concentration (Tmax) 3rd Trimester	3.00 hour (h) Interval 1.0 to 11.88	4.07 hour (h) Interval 1.0 to 9.1	3.05 hour (h) Interval 1.0 to 6.0	6.00 hour (h) Interval 2.02 to 6.02	3.00 hour (h) Interval 2.0 to 6.0	4.00 hour (h) Interval 2.0 to 24.93	3.50 hour (h) Interval 2.0 to 6.0	3.50 hour (h) Interval 2.0 to 4.0
Time to Reach the Maximum Plasma Concentration (Tmax) Postpartum (6-12 W)	3.00 hour (h) Interval 1.0 to 6.0	5.04 hour (h) Interval 1.02 to 12.08	4.00 hour (h) Interval 1.0 to 6.0	4.18 hour (h) Interval 2.02 to 6.03	4.00 hour (h) Interval 1.0 to 9.0	4.00 hour (h) Interval 2.03 to 25.08	4.00 hour (h) Interval 2.0 to 6.0	4.00 hour (h) Interval 2.0 to 4.0
Time to Reach the Maximum Plasma Concentration (Tmax) 2nd Trimester	3.00 hour (h) Interval 0.93 to 5.83	4.17 hour (h) Interval 0.93 to 6.08	4.00 hour (h) Interval 3.0 to 6.08	5.92 hour (h) Interval 2.03 to 6.1	3.05 hour (h) Interval 2.0 to 4.0	4.00 hour (h) Interval 1.0 to 9.0	4.00 hour (h) Interval 3.0 to 6.0	4.03 hour (h) Interval 2.0 to 6.0

PRIMARY outcome

Timeframe: Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=12 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=13 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) Postpartum (6-12 W)	56890 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 26340	7406 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 6188	5004 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2521	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) 2nd Trimester	39370 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 9597	3775 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1265	6617 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2766	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) 3rd Trimester	45880 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 17360	3750 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1336	6846 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1482	—	—	—	—	—

PRIMARY outcome

Timeframe: Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=17 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=17 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=15 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=7 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=7 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) Postpartum (6-12 W)	92116 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 29241	6584 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2861	2714 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1535	99613 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 34862	8643 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 3187	—	—	—
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) 2nd trimester	62289 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 16234	3935 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2063	1792 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 711	47293 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 19058	3862 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2703	—	—	—
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) 3rd trimester	61112 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 13790	3821 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1723	1762 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 662	47991 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 9879	4736 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2917	—	—	—

SECONDARY outcome

Timeframe: Up to postpartum (6-12 weeks)

Population: Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signifies number of participants evaluable for this outcome measure.

Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=16 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=17 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=13 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=19 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=6 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) 2nd trimester Less than(<)50 copies/milliLiter(mL)	6 Participants	9 Participants	12 Participants	13 Participants	6 Participants	—	—	—
Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) 3rd trimester: <50 copies/mL	5 Participants	8 Participants	10 Participants	13 Participants	5 Participants	—	—	—
Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) Postpartum (2-5 weeks): <50 copies/mL	5 Participants	8 Participants	9 Participants	9 Participants	5 Participants	—	—	—
Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) Postpartum (6-12 weeks): <50 copies/mL	6 Participants	7 Participants	8 Participants	10 Participants	5 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)

Population: Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signifies number of participants evaluable for this outcome measure.

Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=17 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=15 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=19 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=7 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value Baseline	2.12 Log 10 copies per milliliter (copies/mL) Standard Error 0.179	1.88 Log 10 copies per milliliter (copies/mL) Standard Error 0.089	2.06 Log 10 copies per milliliter (copies/mL) Standard Error 0.206	1.84 Log 10 copies per milliliter (copies/mL) Standard Error 0.159	1.77 Log 10 copies per milliliter (copies/mL) Standard Error 0.283	—	—	—
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value 4 Weeks after Baseline	-0.26 Log 10 copies per milliliter (copies/mL) Standard Error 0.161	-0.27 Log 10 copies per milliliter (copies/mL) Standard Error 0.145	0.18 Log 10 copies per milliliter (copies/mL) Standard Error 0.182	0.20 Log 10 copies per milliliter (copies/mL) Standard Error 0.172	—	—	—	—
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value 2nd trimester	-0.19 Log 10 copies per milliliter (copies/mL) Standard Error 0.106	-0.16 Log 10 copies per milliliter (copies/mL) Standard Error 0.104	0.16 Log 10 copies per milliliter (copies/mL) Standard Error 0.084	0.16 Log 10 copies per milliliter (copies/mL) Standard Error 0.074	0.1 Log 10 copies per milliliter (copies/mL) Standard Error 0.233	—	—	—
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value 3rd trimester	-0.31 Log 10 copies per milliliter (copies/mL) Standard Error 0.107	-0.23 Log 10 copies per milliliter (copies/mL) Standard Error 0.105	0.17 Log 10 copies per milliliter (copies/mL) Standard Error 0.105	0.25 Log 10 copies per milliliter (copies/mL) Standard Error 0.113	0.21 Log 10 copies per milliliter (copies/mL) Standard Error 0.326	—	—	—
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value Postpartum (2-5 weeks)	-0.18 Log 10 copies per milliliter (copies/mL) Standard Error 0.111	-0.04 Log 10 copies per milliliter (copies/mL) Standard Error 0.146	0.13 Log 10 copies per milliliter (copies/mL) Standard Error 0.168	0.20 Log 10 copies per milliliter (copies/mL) Standard Error 0.273	0.18 Log 10 copies per milliliter (copies/mL) Standard Error 0.304	—	—	—
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value Postpartum (6-12 weeks)	0.09 Log 10 copies per milliliter (copies/mL) Standard Error 0.268	0.11 Log 10 copies per milliliter (copies/mL) Standard Error 0.265	0.05 Log 10 copies per milliliter (copies/mL) Standard Error 0.058	0.08 Log 10 copies per milliliter (copies/mL) Standard Error 0.138	0.23 Log 10 copies per milliliter (copies/mL) Standard Error 0.347	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)

Population: Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure.

Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=16 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=15 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=19 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=7 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Mean Change From Baseline in CD4+ Cell Count Baseline	466.3 10^6 Cells/Liter Standard Error 49.07	497.9 10^6 Cells/Liter Standard Error 64.60	417.47 10^6 Cells/Liter Standard Error 80.469	495.79 10^6 Cells/Liter Standard Error 79.322	594.17 10^6 Cells/Liter Standard Error 108.151	—	—	—
Mean Change From Baseline in CD4+ Cell Count 4 Weeks after Baseline	-14.8 10^6 Cells/Liter Standard Error 23.16	116.3 10^6 Cells/Liter Standard Error 62.41	6.25 10^6 Cells/Liter Standard Error 26.004	24.00 10^6 Cells/Liter Standard Error 56.912	—	—	—	—
Mean Change From Baseline in CD4+ Cell Count 2nd trimester	37.1 10^6 Cells/Liter Standard Error 23.31	154.1 10^6 Cells/Liter Standard Error 44.08	13.77 10^6 Cells/Liter Standard Error 53.225	39.21 10^6 Cells/Liter Standard Error 36.496	13.29 10^6 Cells/Liter Standard Error 34.445	—	—	—
Mean Change From Baseline in CD4+ Cell Count 3rd trimester	83.5 10^6 Cells/Liter Standard Error 29.45	274.9 10^6 Cells/Liter Standard Error 65.41	77.30 10^6 Cells/Liter Standard Error 30.803	89.46 10^6 Cells/Liter Standard Error 26.137	72.17 10^6 Cells/Liter Standard Error 62.882	—	—	—
Mean Change From Baseline in CD4+ Cell Count Postpartum (2-5 weeks)	127.9 10^6 Cells/Liter Standard Error 28.53	186.0 10^6 Cells/Liter Standard Error 43.51	115.36 10^6 Cells/Liter Standard Error 33.584	139.42 10^6 Cells/Liter Standard Error 36.972	163 10^6 Cells/Liter Standard Error 37.177	—	—	—
Mean Change From Baseline in CD4+ Cell Count Postpartum (6-12 weeks)	174.5 10^6 Cells/Liter Standard Error 44.98	323.0 10^6 Cells/Liter Standard Error 63.99	154.90 10^6 Cells/Liter Standard Error 54.131	168.18 10^6 Cells/Liter Standard Error 41.345	244.67 10^6 Cells/Liter Standard Error 100.74	—	—	—

SECONDARY outcome

Timeframe: Up to follow-up phase (16 weeks after postpartum)

Population: Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.

Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load >1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load >200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (<=) 200 copies/mL. For participants with a baseline viral load <=200 copies/mL, virologic failure was defined as viral load of >200 copies/mL (at 2 successive visits) at any point during the study.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=15 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=19 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=7 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Number of Participants With Resistance at Virological Failure	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: On day of delivery - Intrapartum (Visit 6)

Population: Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure.

The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=10 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=10 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=16 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=16 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=11 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=9 Participants Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=5 Participants Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily n=5 Participants Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery Cord Plasma	348.4 nanogram per milliliter (ng/mL) Standard Deviation 322.90	17.07 nanogram per milliliter (ng/mL) Standard Deviation 23.98	228 nanogram per milliliter (ng/mL) Standard Deviation 302	NA nanogram per milliliter (ng/mL) Standard Deviation NA The data was not analyzed in case either the cord or maternal plasma concentration was below quantification limit (lesser than (\<) 5.00 ng/mL).	147 nanogram per milliliter (ng/mL) Standard Deviation 61.3	32.8 nanogram per milliliter (ng/mL) Standard Deviation 16.7	125 nanogram per milliliter (ng/mL) Standard Deviation 106	NA nanogram per milliliter (ng/mL) Standard Deviation NA The data was not analyzed in case either the cord or maternal plasma concentration was below quantification limit (lesser than (\<) 5.00 ng/mL).
Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery Maternal Plasma	2149 nanogram per milliliter (ng/mL) Standard Deviation 1140	316.7 nanogram per milliliter (ng/mL) Standard Deviation 394.4	1663 nanogram per milliliter (ng/mL) Standard Deviation 1691	154 nanogram per milliliter (ng/mL) Standard Deviation 274	421 nanogram per milliliter (ng/mL) Standard Deviation 157	59.0 nanogram per milliliter (ng/mL) Standard Deviation 34.7	857 nanogram per milliliter (ng/mL) Standard Deviation 885	74.5 nanogram per milliliter (ng/mL) Standard Deviation 109

SECONDARY outcome

Timeframe: Birth to age 16 weeks

Population: Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available.

The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=14 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=17 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=11 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=10 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=6 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result	0 infants	0 infants	0 infants	0 infants	0 infants	—	—	—

SECONDARY outcome

Timeframe: Up to follow up period (16 weeks after postpartum)

Population: Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received darunavir 600 milligram (mg) tablets (300\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily n=18 Participants Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=15 Participants Participants received darunavir 800 mg tablets (400\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.	Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily n=19 Participants Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=7 Participants Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.	Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE	14 Participants	17 Participants	12 Participants	9 Participants	5 Participants	—	—	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAE	6 Participants	6 Participants	4 Participants	4 Participants	1 Participants	—	—	—

Adverse Events

Darunavir 600 mg /Ritonavir 100 mg Twice Daily

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Darunavir 800 mg /Ritonavir 100 mg Once Daily

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Etravirine 200 mg Twice Daily

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Rilpivirine 25 mg Once Daily

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Darunavir 800 mg/Cobicistat 150 mg Once Daily

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Darunavir 600 mg /Ritonavir 100 mg Twice Daily n=18 participants at risk Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.	Darunavir 800 mg /Ritonavir 100 mg Once Daily n=18 participants at risk Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=15 participants at risk Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=19 participants at risk Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg/Cobicistat 150 mg Once Daily n=7 participants at risk Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Ear and labyrinth disorders Vertigo	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Eye disorders Vision Blurred	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Postoperative Wound Infection	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Sepsis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Medical Observation	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Transaminases Increased	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Gestational Diabetes	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Headache	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	10.5% 2/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Intra-Uterine Death	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Pre-Eclampsia	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Pregnancy Induced Hypertension	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Premature Labour	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Premature Rupture of Membranes	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Renal and urinary disorders Proteinuria	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Vascular disorders Hypertension	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Blood Pressure Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.

Other adverse events

Measure	Darunavir 600 mg /Ritonavir 100 mg Twice Daily n=18 participants at risk Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.	Darunavir 800 mg /Ritonavir 100 mg Once Daily n=18 participants at risk Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.	Etravirine 200 mg Twice Daily n=15 participants at risk Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum.	Rilpivirine 25 mg Once Daily n=19 participants at risk Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.	Darunavir 800 mg/Cobicistat 150 mg Once Daily n=7 participants at risk Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Investigations Cardiac Murmur	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Psychiatric disorders Depression	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Blood and lymphatic system disorders Anaemia	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	16.7% 3/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Blood and lymphatic system disorders Anaemia of Pregnancy	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Blood and lymphatic system disorders Lymphadenopathy	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Constipation	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	16.7% 3/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Nausea	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	16.7% 3/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	20.0% 3/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Toothache	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	16.7% 3/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	13.3% 2/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Influenza Like Illness	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Pitting Oedema	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Pyrexia	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Immune system disorders Seasonal Allergy	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Bacteriuria	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Carbuncle	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Fungal Infection	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Genital Herpes	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Herpes Zoster	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Nasopharyngitis	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Otitis Media	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Pharyngitis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Sinusitis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Subcutaneous Abscess	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Tinea Pedis	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Upper Respiratory Tract Infection	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Urinary Tract Infection	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Vaginal Infection	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Vaginitis Bacterial	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	28.6% 2/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Injury, poisoning and procedural complications Contusion	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Injury, poisoning and procedural complications Eye Injury	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Alanine Aminotransferase Increased	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Blood Albumin Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Blood Amylase Increased	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Blood Pressure Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Lipase Increased	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Methicillin-Resistant Staphylococcal Aureus Test Positive	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Neutrophil Count Decreased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Streptococcal Identification Test Positive	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Renal and urinary disorders Hydronephrosis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Transaminases Increased	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Anorexia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Gestational Diabetes	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Hyperlipidaemia	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Carpal Tunnel Syndrome	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Dizziness	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Headache	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	13.3% 2/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Labour Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Postpartum Haemorrhage	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Pregnancy Induced Hypertension	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Premature Labour	22.2% 4/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	13.3% 2/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Psychiatric disorders Insomnia	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Psychiatric disorders Major Depression	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Psychiatric disorders Postpartum Depression	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Genital Discharge	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.3% 1/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	10.5% 2/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Respiratory, thoracic and mediastinal disorders Asthma	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	13.3% 2/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Skin and subcutaneous tissue disorders Dry Skin	5.6% 1/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	11.1% 2/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Vascular disorders Hypertension	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	6.7% 1/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Gastrointestinal disorders Haemorrhoids	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Eye disorders Vision Blurred	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Chest Pain	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Fatigue	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
General disorders Oedema Peripheral	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations Heart Rate Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Investigations High Density Lipoprotein Increased	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Hypoaesthesia	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Migraine	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Migraine with Aura	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Nervous system disorders Poor Quality Sleep	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Pregnancy, puerperium and perinatal conditions Uterine Contractions During Pregnancy	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Pelvic Discomfort	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Reproductive system and breast disorders Vulvovaginal Pruritus	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
Vascular disorders Hypotension	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/18 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/15 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	0.00% 0/19 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.	14.3% 1/7 • Up to Follow up phase (16 weeks after postpartum) Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.

Additional Information

Medical Leader, Medical Department

Janssen Scientific Affairs, LLC

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER