Trial Outcomes & Findings for The Women TAF-FTC Benchmark Study (NCT NCT05140954)

NCT ID: NCT05140954

Last Updated: 2025-10-27

Results Overview

The frequency of graded adverse events by arm, including emergent HIV infection during the study period.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

54 participants

Primary outcome timeframe

Assessed through the 10 week DOT dosing period

Results posted on

2025-10-27

Participant Flow

Seventy-one women were screened for study participation starting 28 March 2023 to 11 September 2023 at the Kenya Medical Research Institute, Center for Clinical Research, Thika site in Kenya. The Of these, 54 healthy volunteer women ages 18-30 at low risk of HIV acquisition were enrolled into the study and randomized. The first participant was randomized on 10 April 2023.

Participant milestones

Participant milestones
Measure	Poor Adherence Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Overall Study STARTED	18	18	18
Overall Study COMPLETED	16	17	18
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Poor Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week)	Total n=54 Participants Total of all reporting groups
Age, Customized Median age	22 years n=18 Participants	24.5 years n=18 Participants	23 years n=18 Participants	23 years n=54 Participants
Sex: Female, Male Female	18 Participants n=18 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	54 Participants n=54 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	18 participants n=18 Participants	18 participants n=18 Participants	18 participants n=18 Participants	54 participants n=54 Participants

PRIMARY outcome

Timeframe: Assessed through the 10 week DOT dosing period

The frequency of graded adverse events by arm, including emergent HIV infection during the study period.

Outcome measures

Outcome measures
Measure	Poor Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Frequency of Adverse Events Grade 1 adverse events	69 Number of adverse events	60 Number of adverse events	62 Number of adverse events
Frequency of Adverse Events Grade 2 adverse events	1 Number of adverse events	1 Number of adverse events	0 Number of adverse events
Frequency of Adverse Events Grade 3 or higher adverse events	0 Number of adverse events	0 Number of adverse events	0 Number of adverse events
Frequency of Adverse Events Emergent HIV infection	0 Number of adverse events	0 Number of adverse events	0 Number of adverse events

PRIMARY outcome

Timeframe: Assessed at week 10

TFV-DP and FTC-TP concentrations observed in dried blood spots (DBS) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Outcome measures

Outcome measures
Measure	Poor Adherence n=16 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence n=17 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS) Observed FTC-TP concentrations	261 fmol/punches Interval 152.0 to 341.0	976 fmol/punches Interval 737.0 to 1359.0	4031 fmol/punches Interval 2913.0 to 4342.0
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS) Observed TFV-DP concentrations	432 fmol/punches Interval 407.0 to 504.0	1214 fmol/punches Interval 930.0 to 1377.0	2345 fmol/punches Interval 2063.0 to 3006.0

PRIMARY outcome

Timeframe: Assessed at week 4

Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Outcome measures

Outcome measures
Measure	Poor Adherence n=17 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence n=17 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs) Observed TFV-DP concentrations	70 fmol/10^6 cells Interval 55.0 to 94.0	229 fmol/10^6 cells Interval 159.0 to 278.0	680 fmol/10^6 cells Interval 462.0 to 864.0
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs) Observed FTC-TP concentrations	407 fmol/10^6 cells Interval 337.0 to 500.0	1859 fmol/10^6 cells Interval 1126.0 to 2990.0	6402 fmol/10^6 cells Interval 4845.0 to 8010.0

PRIMARY outcome

Timeframe: Assessed through 10 weeks

Fitted steady-state TFV-DP concentrations after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Outcome measures

Outcome measures
Measure	Poor Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	Moderate Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)	468 fmol/punch Interval 423.0 to 531.0	1010 fmol/punch Interval 853.0 to 1231.0	2355 fmol/punch Interval 1923.0 to 2609.0

Adverse Events

2 doses per week (Poor Adherence)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

4 doses per week (Moderate Adherence)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

7 doses per week (Perfect Adherence)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Kenneth K. Mugwanya, MBChB, MS, PhD

Departments of Global Health and Epidemiology, University of Washington

Phone: +1 206 520-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	2 doses per week (Poor Adherence) n=18 participants at risk Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week	4 doses per week (Moderate Adherence) n=18 participants at risk Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week	7 doses per week (Perfect Adherence) n=18 participants at risk Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Blood and lymphatic system disorders Tonsilitis	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Abdominal pain	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Bloating	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Gastritis	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Vomiting	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Nausea	44.4% 8/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	38.9% 7/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	33.3% 6/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
General disorders Fatigue	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
General disorders Flu-like symptoms	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Nervous system disorders Headache	38.9% 7/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	22.2% 4/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	27.8% 5/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Renal and urinary disorders Urinary tract infection	22.2% 4/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Reproductive system and breast disorders Breast pain	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Reproductive system and breast disorders Excessive spotting	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Pharyngitis	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Rhinitis	22.2% 4/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	27.8% 5/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	38.9% 7/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	33.3% 6/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	38.9% 7/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Skin and subcutaneous tissue disorders Dermatitis	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Skin and subcutaneous tissue disorders Wound	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Skin and subcutaneous tissue disorders Fungal skin infection	16.7% 3/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)