Trial Outcomes & Findings for A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) (NCT NCT05630755)
NCT ID: NCT05630755
Last Updated: 2025-11-18
Results Overview
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
Week 48
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
Participants will receive doravirine/islatravir (DOR/ISL) 100 mg/0.25 mg and Placebo to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Overall Study
STARTED
|
343
|
171
|
|
Overall Study
Treated
|
342
|
171
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
333
|
165
|
Reasons for withdrawal
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
Participants will receive doravirine/islatravir (DOR/ISL) 100 mg/0.25 mg and Placebo to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
|
Overall Study
Randomized by Mistake Without Study Treatment
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
|
Overall Study
Participant moved away from trial site
|
0
|
1
|
|
Overall Study
Status not Recorded
|
316
|
161
|
Baseline Characteristics
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
Baseline characteristics by cohort
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=343 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 12.9 • n=202 Participants
|
47.6 Years
STANDARD_DEVIATION 13.1 • n=283 Participants
|
47.6 Years
STANDARD_DEVIATION 12.9 • n=120 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=202 Participants
|
36 Participants
n=283 Participants
|
110 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
269 Participants
n=202 Participants
|
135 Participants
n=283 Participants
|
404 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
73 Participants
n=202 Participants
|
44 Participants
n=283 Participants
|
117 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
262 Participants
n=202 Participants
|
125 Participants
n=283 Participants
|
387 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
10 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=202 Participants
|
10 Participants
n=283 Participants
|
30 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
112 Participants
n=202 Participants
|
47 Participants
n=283 Participants
|
159 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=202 Participants
|
106 Participants
n=283 Participants
|
312 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention.
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48
|
1.5 Percentage of Participants
|
0.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE is reported.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants Who Experience Adverse Events (AEs) Through Week 48
|
74.6 Percentage of Participants
|
71.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE is reported.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 48
|
2.9 Percentage of Participants
|
1.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention.
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
|
91.8 Percentage of Participants
|
94.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention.
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
|
91.5 Percentage of Participants
|
94.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline at Day 1 and Week 48Population: The analysis population includes all randomized participants who received ≥1 dose of study intervention and who had baseline data for CD4+ T-cell count.
Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 and corresponding 2-sided 95% confidence intervals were calculated based on cLDA models adjusted by treatment group, time, and the interaction of time-by-treatment group.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=315 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=161 Participants
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4-positive (CD4+) T-cell Count at Week 48
|
30.40 Cells/mm^3
Interval 10.98 to 49.83
|
28.19 Cells/mm^3
Interval -4.46 to 60.83
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Per protocol, participants with HIV-1 RNA ≥400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Participants without available assay results were not included.
Participants with clinically significant confirmed viremia \[2 consecutive occurences 4 weeks (+-1 week) apart of HIV-1 RNA ≥200 copies/mL at any time during the study\] or who discontinue study intervention for another reason with HIV-1 RNA ≥200 copies/mL at the time of discontinuation met the criteria for post-baseline resistance testing. Per protocol, participants with HIV-1 RNA ≥400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Plasma samples were collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and virus susceptibility to study intervention. The percentage of participants in the resistance analysis subset with treatment-emergent resistance-associated substitutions to the study intervention is presented.
Outcome measures
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=1 Participants
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48
|
0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Week 96Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Percentage of participants with HIV-1 RNA \<200 copies/mL at Week 96 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline at Day 1 and Week 96Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Number of participants with evidence of viral drug resistance-associated substitutions at Week 96 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 144Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 144Percentage of participants with HIV-1 RNA \<200 copies/mL at Week 144 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 144Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 144 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline at Day 1 and Week 144Mean change from baseline at Day 1 in CD4+ T-cell count at Week 144 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 144Number of participants with evidence of viral drug resistance-associated substitutions at Week 144 will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 144An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 144An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
Outcome data not reported
Adverse Events
DOR/ISL and Placebo to BIC/FTC/TAF
Serious events: 15 serious events
Other events: 94 other events
Deaths: 0 deaths
BIC/FTC/TAF and Placebo to DOR/ISL
Serious events: 11 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 participants at risk
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 participants at risk
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.58%
2/342 • Number of events 2 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Acute hepatitis C
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
1.8%
3/171 • Number of events 3 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hepatitis C
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Orchitis
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/342 • Number of events 2 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer metastatic
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Intracranial hypotension
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/342 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.58%
1/171 • Number of events 2 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
1/342 • Number of events 1 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
0.00%
0/171 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
DOR/ISL and Placebo to BIC/FTC/TAF
n=342 participants at risk
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
BIC/FTC/TAF and Placebo to DOR/ISL
n=171 participants at risk
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
22/342 • Number of events 26 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
4.7%
8/171 • Number of events 8 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
3.2%
11/342 • Number of events 11 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
5.3%
9/171 • Number of events 9 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
20/342 • Number of events 21 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
3.5%
6/171 • Number of events 6 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
3.8%
13/342 • Number of events 13 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
7.0%
12/171 • Number of events 12 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
6.1%
21/342 • Number of events 22 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
5.3%
9/171 • Number of events 9 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
2.6%
9/342 • Number of events 9 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
5.3%
9/171 • Number of events 10 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
21/342 • Number of events 25 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
7.6%
13/171 • Number of events 13 • Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER