Trial Outcomes & Findings for Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035) (NCT NCT02759315)

Last Updated: 2019-06-26

Results Overview

The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma \< lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

160 participants

Primary outcome timeframe

Week 24 (12 weeks after completing study therapy)

Results posted on

2019-06-26

Participant Flow

Adult participants with hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, or 6 infection were enrolled at 5 study centers in the United States. Participants with HCV GT5 infection were initially intended for inclusion but none were enrolled.

Participant milestones

Participant milestones
Measure	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Overall Study STARTED	39	20	3	69	29
Overall Study COMPLETED	29	19	2	65	28
Overall Study NOT COMPLETED	10	1	1	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Overall Study Adverse Event	0	1	0	0	0
Overall Study Death	1	0	0	0	0
Overall Study Lost to Follow-up	4	0	0	2	0
Overall Study Protocol Violation	0	0	0	0	1
Overall Study Study terminated prior to completion	5	0	1	2	0

Baseline Characteristics

Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	Total n=160 Participants Total of all reporting groups
Age, Continuous	49.8 Years STANDARD_DEVIATION 10.7 • n=5 Participants	57.2 Years STANDARD_DEVIATION 6.8 • n=7 Participants	48.7 Years STANDARD_DEVIATION 10.3 • n=5 Participants	56.5 Years STANDARD_DEVIATION 8.5 • n=4 Participants	61.3 Years STANDARD_DEVIATION 1.5 • n=21 Participants	51.9 Years STANDARD_DEVIATION 10.3 • n=8 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	67 Participants n=8 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	15 Participants n=4 Participants	2 Participants n=21 Participants	93 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	27 Participants n=7 Participants	39 Participants n=5 Participants	19 Participants n=4 Participants	0 Participants n=21 Participants	149 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 24 (12 weeks after completing study therapy)

Population: All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.

Outcome measures

Outcome measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=28 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)	97.1 Percentage of Participants Interval 89.9 to 99.6	100.0 Percentage of Participants Interval 87.7 to 100.0	76.9 Percentage of Participants Interval 60.7 to 88.9	90.0 Percentage of Participants Interval 68.3 to 98.8	66.7 Percentage of Participants Interval 9.4 to 99.2	—

PRIMARY outcome

Timeframe: Up to Week 14 (up to 2 weeks after completing study therapy)

Population: All participants who received ≥1 dose of study drug are included.

The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An 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 measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants With ≥1 Adverse Events (AEs)	52.2 Percentage of Participants	44.8 Percentage of Participants	43.6 Percentage of Participants	55.0 Percentage of Participants	66.7 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Week 12

Population: All participants who received ≥1 dose of study drug are included.

The percentage of participants discontinuing from study therapy during the treatment period was determined. An 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 measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants Withdrawing From Study Therapy Due to an AE	0.0 Percentage of Participants	3.4 Percentage of Participants	0.0 Percentage of Participants	5.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Week 14 (up to 2 weeks after completing study therapy)

Population: All participants who received ≥1 dose of study drug are included.

The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>500 IU/L; 3) first instance of ALT or AST \>3x nadir and \>3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2; or 4) first instance of serum creatinine \>1.3x ULN and elevated from baseline.

Outcome measures

Outcome measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) Overdose	4.3 Percentage of Participants	3.4 Percentage of Participants	5.1 Percentage of Participants	—	—	—
Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) Non-overdose ECI	2.8 Percentage of Participants	—	2.5 Percentage of Participants	—	—	—

SECONDARY outcome

Timeframe: Week 36 (24 weeks after completing study therapy)

The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection.

Outcome measures

Outcome measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=53 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=28 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=36 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=14 Participants Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)	96.2 Percentage of Participants	100.0 Percentage of Participants	75.0 Percentage of Participants	90.0 Percentage of Participants	66.7 Percentage of Participants	100.0 Percentage of Participants

SECONDARY outcome

Timeframe: 12 weeks after the end of all study therapy (24 weeks)

The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA \< LLOQ while on treatment); 2) rebound (\>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \<LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or GT1b infection

Outcome measures

Outcome measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=54 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=28 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=15 Participants Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants With Virologic Failure (VF)	3.7 Percentage of Participants	0.0 Percentage of Participants	23.1 Percentage of Participants	5.0 Percentage of Participants	33.3 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: 12 weeks after the end of all study therapy (24 weeks)

Population: All participants who received ≥1 dose of study treatment, and who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, and who had baseline sequencing data available, are included.

The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

Outcome measures

Outcome measures
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 Participants Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=28 Participants Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 Participants Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=19 Participants Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 Participants Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12	97.1 Percentage of Participants	100.0 Percentage of Participants	97.4 Percentage of Participants	94.7 Percentage of Participants	66.6 Percentage of Participants	—

Adverse Events

GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 1 deaths

GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 participants at risk Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 participants at risk Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 participants at risk Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 participants at risk Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 participants at risk Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Gastrointestinal disorders Melaena	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Oesophagitis haemorrhagic	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
General disorders Drug withdrawal syndrome	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Arthritis bacterial	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Urinary tract infection	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	2.6% 1/39 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Nervous system disorders Sciatica	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Nervous system disorders Syncope	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Psychiatric disorders Schizophrenia	1.4% 1/69 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Renal and urinary disorders Acute kidney injury	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.

Other adverse events

Other adverse events
Measure	GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=69 participants at risk Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=29 participants at risk Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=39 participants at risk Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=20 participants at risk Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.	GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg n=3 participants at risk Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
Gastrointestinal disorders Abdominal distension	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	33.3% 1/3 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Abdominal pain	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.1% 2/39 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Diarrhoea	5.8% 4/69 • Number of events 4 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	10.3% 4/39 • Number of events 4 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Flatulence	2.9% 2/69 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	2.6% 1/39 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	10.0% 2/20 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Nausea	8.7% 6/69 • Number of events 6 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	3.4% 1/29 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	7.7% 3/39 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	10.0% 2/20 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
General disorders Fatigue	10.1% 7/69 • Number of events 7 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	6.9% 2/29 • Number of events 2 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	33.3% 1/3 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Nasopharyngitis	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	15.0% 3/20 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Upper respiratory tract infection	1.4% 1/69 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	3.4% 1/29 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	33.3% 1/3 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Infections and infestations Urinary tract infection	4.3% 3/69 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	3.4% 1/29 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	2.6% 1/39 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	33.3% 1/3 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Injury, poisoning and procedural complications Accidental overdose	4.3% 3/69 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	3.4% 1/29 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.1% 2/39 • Number of events 4 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/20 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Nervous system disorders Headache	4.3% 3/69 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	10.3% 3/29 • Number of events 3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	2.6% 1/39 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/3 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.
Psychiatric disorders Insomnia	0.00% 0/69 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/29 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	0.00% 0/39 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	5.0% 1/20 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.	33.3% 1/3 • Number of events 1 • Up to 36 weeks (up to 24 weeks after completing study treatment) An 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. All participants who received ≥1 dose of study drug are included.

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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER