Trial Outcomes & Findings for A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007) (NCT NCT01632345)
NCT ID: NCT01632345
Last Updated: 2019-07-18
Results Overview
Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
342 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2019-07-18
Participant Flow
210 participants were randomized to Part I and 132 participants were randomized to Part II.
Participant milestones
| Measure |
Part I: Doravirine 25 mg
Doravirine 25 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 50 mg
Doravirine 50 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 100 mg
Doravirine 100 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 200 mg
Doravirine 200 mg once daily plus TRUVADA once daily in Part I
|
Part I: Efavirenz 600 mg
Efavirenz 600 mg once daily plus TRUVADA once daily in Part I
|
Part II: Doravirine 100 mg
Doravirine 100 mg once daily plus TRUVADA once daily in Part II
|
Part II: Efavirenz 600 mg
Efavirenz 600 mg once daily plus TRUVADA once daily in Part II
|
|---|---|---|---|---|---|---|---|
|
Randomized Participants
STARTED
|
41
|
43
|
42
|
41
|
43
|
66
|
66
|
|
Randomized Participants
COMPLETED
|
41
|
43
|
42
|
41
|
43
|
66
|
66
|
|
Randomized Participants
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment: Part I
STARTED
|
41
|
43
|
42
|
41
|
43
|
0
|
0
|
|
Treatment: Part I
Treated
|
40
|
43
|
42
|
41
|
43
|
0
|
0
|
|
Treatment: Part I
COMPLETED
|
29
|
28
|
32
|
33
|
30
|
0
|
0
|
|
Treatment: Part I
NOT COMPLETED
|
12
|
15
|
10
|
8
|
13
|
0
|
0
|
|
Treatment: Part II
STARTED
|
0
|
0
|
0
|
0
|
0
|
66
|
66
|
|
Treatment: Part II
Treated
|
0
|
0
|
0
|
0
|
0
|
66
|
66
|
|
Treatment: Part II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
55
|
55
|
|
Treatment: Part II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
11
|
11
|
Reasons for withdrawal
| Measure |
Part I: Doravirine 25 mg
Doravirine 25 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 50 mg
Doravirine 50 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 100 mg
Doravirine 100 mg once daily plus TRUVADA once daily in Part I
|
Part I: Doravirine 200 mg
Doravirine 200 mg once daily plus TRUVADA once daily in Part I
|
Part I: Efavirenz 600 mg
Efavirenz 600 mg once daily plus TRUVADA once daily in Part I
|
Part II: Doravirine 100 mg
Doravirine 100 mg once daily plus TRUVADA once daily in Part II
|
Part II: Efavirenz 600 mg
Efavirenz 600 mg once daily plus TRUVADA once daily in Part II
|
|---|---|---|---|---|---|---|---|
|
Treatment: Part I
Adverse Event
|
1
|
4
|
2
|
1
|
3
|
0
|
0
|
|
Treatment: Part I
Lack of Efficacy
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Treatment: Part I
Lost to Follow-up
|
3
|
2
|
1
|
3
|
4
|
0
|
0
|
|
Treatment: Part I
Non-Compliance with Study Drug
|
3
|
2
|
2
|
1
|
0
|
0
|
0
|
|
Treatment: Part I
Physician Decision
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Treatment: Part I
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment: Part I
Protocol Deviation
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Treatment: Part I
Withdrawal by Subject
|
3
|
4
|
4
|
1
|
4
|
0
|
0
|
|
Treatment: Part II
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
3
|
8
|
|
Treatment: Part II
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Treatment: Part II
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Treatment: Part II
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
Baseline Characteristics
A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)
Baseline characteristics by cohort
| Measure |
Doravirine 25 mg: Part I/II Combined
n=40 Participants
Doravirine 25 mg once daily plus TRUVADA once daily
|
Doravirine 50 mg Part I/II Combined
n=43 Participants
Doravirine 50 mg once daily plus TRUVADA once daily
|
Doravirine 100 mg: Part I/II Combined
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily
|
Doravirine 200 mg: Part I/II Combined
n=41 Participants
Doravirine 200 mg once daily plus TRUVADA once daily
|
Efavirenz 600 mg: Part I/II Combined
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 10.71 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 8.85 • n=4 Participants
|
35.2 years
STANDARD_DEVIATION 9.08 • n=21 Participants
|
36.4 years
STANDARD_DEVIATION 10.62 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
315 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.
Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
n=42 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
n=41 Participants
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
n=42 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=40 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=43 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)
|
71.4 Percentage of participants
Interval 55.4 to 84.3
|
85.4 Percentage of participants
Interval 70.8 to 94.4
|
83.3 Percentage of participants
Interval 68.6 to 93.0
|
90.0 Percentage of participants
Interval 76.3 to 97.2
|
93.0 Percentage of participants
Interval 80.9 to 98.5
|
PRIMARY outcome
Timeframe: Up to Week 24Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.
Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
n=42 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
n=41 Participants
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
n=42 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=40 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=43 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
4.8 Percentage of participants
Interval 0.6 to 16.2
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
7.0 Percentage of participants
Interval 1.5 to 19.1
|
PRIMARY outcome
Timeframe: Up to Week 24Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
75.0 Percentage of participants
Interval 65.7 to 82.8
|
85.2 Percentage of participants
Interval 77.1 to 91.3
|
PRIMARY outcome
Timeframe: Up to Week 8Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
24.1 Percentage of participants
Interval 16.4 to 33.3
|
44.4 Percentage of participants
Interval 34.9 to 54.3
|
PRIMARY outcome
Timeframe: Up to Week 24Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
26.9 Percentage of participants
Interval 18.8 to 36.2
|
47.2 Percentage of participants
Interval 37.5 to 57.1
|
PRIMARY outcome
Timeframe: Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<40 copies/mL) at 24 weeks of study treatment.
Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA \<40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA \<40 copies/mL in Part I.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
n=42 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
n=41 Participants
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
n=42 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=40 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=43 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
|
71.4 Percentage of participants
Interval 55.4 to 84.3
|
80.5 Percentage of participants
Interval 65.1 to 91.2
|
64.3 Percentage of participants
Interval 48.0 to 78.4
|
80.0 Percentage of participants
Interval 64.4 to 90.9
|
74.4 Percentage of participants
Interval 58.8 to 86.5
|
PRIMARY outcome
Timeframe: Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<40 copies/mL) at 24 weeks of study treatment.
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA \<40 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=107 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
72.9 Percentage of participants
Interval 63.4 to 81.0
|
73.1 Percentage of participants
Interval 63.8 to 81.2
|
SECONDARY outcome
Timeframe: Week 48Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<40 copies/mL) at 48 weeks of study treatment.
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA \<40 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=107 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
77.8 Percentage of participants
Interval 68.8 to 85.2
|
79.4 Percentage of participants
Interval 70.5 to 86.6
|
SECONDARY outcome
Timeframe: Week 96Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<40 copies/mL) at 96 weeks of study treatment.
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA \<40 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
75.0 Percentage of participants
Interval 65.7 to 82.8
|
75.9 Percentage of participants
Interval 66.7 to 83.6
|
SECONDARY outcome
Timeframe: Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<200 copies/mL) at 24 weeks of study treatment.
Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA \<200 copies/mL in Part I.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
n=42 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
n=41 Participants
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
n=42 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=40 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=43 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
|
92.9 Percentage of participants
Interval 80.5 to 98.5
|
90.2 Percentage of participants
Interval 76.9 to 97.3
|
81.0 Percentage of participants
Interval 65.9 to 91.4
|
85.0 Percentage of participants
Interval 70.2 to 94.3
|
83.7 Percentage of participants
Interval 69.3 to 93.2
|
SECONDARY outcome
Timeframe: Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<200 copies/mL) at 24 weeks of study treatment.
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA \<200 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=107 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
89.7 Percentage of participants
Interval 82.3 to 94.8
|
87.0 Percentage of participants
Interval 79.2 to 92.7
|
SECONDARY outcome
Timeframe: Week 48Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV RNA (\<200 copies/mL) at 48 weeks of study treatment.
Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA \<200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA \<200 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=107 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
85.2 Percentage of participants
Interval 77.1 to 91.3
|
85.0 Percentage of participants
Interval 76.9 to 91.2
|
SECONDARY outcome
Timeframe: Week 96Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (\<200 copies/mL) at 96 weeks of study treatment.
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA \<200 copies/mL in Part I \& Part II combined.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
79.6 Percentage of participants
Interval 70.8 to 86.8
|
75.9 Percentage of participants
Interval 66.7 to 83.6
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.
Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
n=41 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
n=40 Participants
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
n=40 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=38 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=41 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
|
133.6 cells/mm^3
Interval 100.4 to 166.8
|
140.7 cells/mm^3
Interval 95.6 to 185.7
|
121.1 cells/mm^3
Interval 73.3 to 169.0
|
154.1 cells/mm^3
Interval 115.1 to 193.1
|
112.9 cells/mm^3
Interval 74.5 to 151.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.
Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=106 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=101 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
152.3 cells/mm^3
Interval 121.7 to 182.8
|
146.0 cells/mm^3
Interval 113.1 to 178.8
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 48 weeks of study treatment.
Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=102 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=100 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
191.9 cells/mm^3
Interval 160.8 to 223.1
|
194.5 cells/mm^3
Interval 163.2 to 225.9
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 96 weeks of study treatment.
A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=95 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=93 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
259.2 cells/mm^3
Interval 220.0 to 298.3
|
263.6 cells/mm^3
Interval 218.1 to 309.1
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
87.0 Percentage of participants
Interval 79.2 to 92.7
|
89.8 Percentage of participants
Interval 82.5 to 94.8
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96.
Outcome measures
| Measure |
Doravirine 100 mg: Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 200 mg: Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg: Part I/II (Combined)
n=108 Participants
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
Efavirenz 600 mg: Part I/II (Combined)
n=108 Participants
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
|
—
|
—
|
—
|
89.8 Percentage of participants
Interval 82.5 to 94.8
|
96.3 Percentage of participants
Interval 90.8 to 99.0
|
Adverse Events
Doravirine 25 mg (n=40)
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Doravirine 50 mg (n=43)
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Doravirine 100 mg (n=108)
Serious events: 11 serious events
Other events: 78 other events
Deaths: 0 deaths
Doravirine 200 mg (n=41)
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Efavirenz 600 mg: Part I (n=108)
Serious events: 13 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doravirine 25 mg (n=40)
n=40 participants at risk
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 50 mg (n=43)
n=43 participants at risk
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg (n=108)
n=108 participants at risk
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I \& Part II (Combined)
|
Doravirine 200 mg (n=41)
n=41 participants at risk
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I (n=108)
n=108 participants at risk
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I \& Part II (Combined)
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Acute hepatitis C
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma high grade
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
Other adverse events
| Measure |
Doravirine 25 mg (n=40)
n=40 participants at risk
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 50 mg (n=43)
n=43 participants at risk
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
|
Doravirine 100 mg (n=108)
n=108 participants at risk
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I \& Part II (Combined)
|
Doravirine 200 mg (n=41)
n=41 participants at risk
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
|
Efavirenz 600 mg: Part I (n=108)
n=108 participants at risk
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I \& Part II (Combined)
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
4/43 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
10/40 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
4/43 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
14.8%
16/108 • Number of events 18 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.2%
5/41 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
16.7%
18/108 • Number of events 20 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
16.3%
7/43 • Number of events 8 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.0%
13/108 • Number of events 16 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
22.0%
9/41 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
10.2%
11/108 • Number of events 12 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.4%
1/41 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
6.5%
7/108 • Number of events 8 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
General disorders
Fatigue
|
17.5%
7/40 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.6%
5/43 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.2%
5/41 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
6.5%
7/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Acute sinusitis
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Bronchitis
|
12.5%
5/40 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.2%
5/41 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.1%
12/108 • Number of events 13 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Conjunctivitis
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
8.3%
9/108 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Influenza
|
15.0%
6/40 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.2%
5/41 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.6%
5/43 • Number of events 12 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
17.6%
19/108 • Number of events 31 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
29.3%
12/41 • Number of events 17 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.0%
13/108 • Number of events 16 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Oral herpes
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.6%
5/43 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Syphilis
|
10.0%
4/40 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
14.6%
6/41 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.4%
8/108 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Tinea pedis
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Tonsillitis
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
4/40 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
10/108 • Number of events 14 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
12.0%
13/108 • Number of events 19 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
10.0%
4/40 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.6%
5/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.6%
5/43 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
10/108 • Number of events 14 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
11.6%
5/43 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
14.8%
16/108 • Number of events 17 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
29.6%
32/108 • Number of events 38 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Headache
|
12.5%
5/40 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
14.0%
6/43 • Number of events 8 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
13.0%
14/108 • Number of events 27 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
17.1%
7/41 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
13.9%
15/108 • Number of events 26 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Nervous system disorders
Somnolence
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Abnormal dreams
|
12.5%
5/40 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
20.9%
9/43 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
6.5%
7/108 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.8%
4/41 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
17.6%
19/108 • Number of events 21 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 9 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
10.2%
11/108 • Number of events 12 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
14.0%
6/43 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
10/108 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Nightmare
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
8.3%
9/108 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
9.3%
10/108 • Number of events 12 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Psychiatric disorders
Sleep disorder
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.7%
2/43 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.4%
8/108 • Number of events 11 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
2/40 • Number of events 5 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Number of events 7 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.3%
1/43 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.3%
3/41 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
2/40 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
1.9%
2/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/108 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/43 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.93%
1/108 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
3.7%
4/108 • Number of events 4 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
0.00%
0/41 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
2.8%
3/108 • Number of events 3 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
7.0%
3/43 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
5.6%
6/108 • Number of events 6 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
4.9%
2/41 • Number of events 2 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
8.3%
9/108 • Number of events 10 • 96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60