Trial Outcomes & Findings for Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041) (NCT NCT02956629)

Last Updated: 2021-02-02

Results Overview

Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (\<lower limit of quantification \[LLOQ\] of 15 IU/mL) for at least 12 weeks after completing treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

282 participants

Primary outcome timeframe

12 weeks after completing study therapy (Week 24)

Results posted on

2021-02-02

Participant Flow

Males and females of at least 18 years of age, with chronic Hepatitis C Virus (HCV) infection were enrolled in this study.

Participant milestones

Participant milestones
Measure	HCV Genotype (GT) 1 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.	HCV GT2 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Study STARTED	78	47	61	56	18	22
Overall Study COMPLETED	73	41	57	55	18	21
Overall Study NOT COMPLETED	5	6	4	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HCV Genotype (GT) 1 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.	HCV GT2 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Study Adverse Event	0	0	1	0	0
Overall Study Lost to Follow-up	2	5	3	1	1
Overall Study Withdrawal by Subject	3	1	0	0	0

Baseline Characteristics

Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	Total n=282 Participants Total of all reporting groups
Age, Continuous	47.9 Years STANDARD_DEVIATION 12.6 • n=5 Participants	52.7 Years STANDARD_DEVIATION 11.9 • n=7 Participants	48.4 Years STANDARD_DEVIATION 10.1 • n=5 Participants	46.4 Years STANDARD_DEVIATION 13.0 • n=4 Participants	57.4 Years STANDARD_DEVIATION 12.4 • n=21 Participants	53.3 Years STANDARD_DEVIATION 11.0 • n=8 Participants	49.5 Years STANDARD_DEVIATION 12.2 • n=8 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	23 Participants n=4 Participants	11 Participants n=21 Participants	6 Participants n=8 Participants	126 Participants n=8 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants	33 Participants n=4 Participants	7 Participants n=21 Participants	16 Participants n=8 Participants	156 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	0 Participants n=8 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	22 Participants n=8 Participants	29 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	0 Participants n=8 Participants	22 Participants n=8 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	44 Participants n=7 Participants	57 Participants n=5 Participants	47 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	221 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	6 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	0 Participants n=8 Participants

PRIMARY outcome

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

Population: All participants who were assigned to treatment, and received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)	92.3 Percentage of participants Interval 84.0 to 97.1	91.5 Percentage of participants Interval 79.6 to 97.6	73.8 Percentage of participants Interval 60.9 to 84.2	98.2 Percentage of participants Interval 90.4 to 100.0	100.0 Percentage of participants Interval 81.5 to 100.0	90.9 Percentage of participants Interval 70.8 to 98.9

PRIMARY outcome

Timeframe: Up to Week 14

Population: All participants who received at least one dose of study treatment.

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Experiencing an Adverse Event (AE)	60.3 Percentage of participants	61.7 Percentage of participants	57.4 Percentage of participants	55.4 Percentage of participants	77.8 Percentage of participants	77.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 14

Population: All participants who received at least one dose of study treatment

Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Experiencing an AE of Clinical Importance (ECI)	1.3 Percentage of participants	2.1 Percentage of participants	1.6 Percentage of participants	3.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 14

Population: All participants who received at least one dose of study treatment.

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Experiencing a Serious Adverse Event (SAE)	3.8 Percentage of participants	2.1 Percentage of participants	1.6 Percentage of participants	3.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 14

Population: All participants who received at least one dose of study treatment.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Experiencing a Drug-related AE	37.2 Percentage of participants	27.7 Percentage of participants	36.1 Percentage of participants	28.6 Percentage of participants	50.0 Percentage of participants	22.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 14

Population: All participants who received at least one dose of study treatment.

A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Experiencing a Drug-related SAE	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: All participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants Discontinuing Study Therapy Due to an AE	1.3 Percentage of participants	2.1 Percentage of participants	1.6 Percentage of participants	1.8 Percentage of participants	0 Percentage of participants	4.5 Percentage of participants

SECONDARY outcome

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

Population: All participants who were assigned to treatment, and received at least one dose of study medication.

Plasma levels of HCV RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (\<LLOQ of 15 IU/mL), for at least 24 weeks after completing treatment.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)	89.7 Percentage of participants Interval 80.8 to 95.5	85.1 Percentage of participants Interval 71.7 to 93.8	72.1 Percentage of participants Interval 59.2 to 82.9	96.4 Percentage of participants Interval 87.7 to 99.6	100.0 Percentage of participants Interval 81.5 to 100.0	81.8 Percentage of participants Interval 59.7 to 94.8

SECONDARY outcome

Timeframe: Up to Week 24

Population: Participants who followed the protocol sufficiently to allow the analysis of the results. Participants who deviated substantially from the protocol were excluded.

Virologic failure is the detection of HCV RNA among participants who do not discontinue study for non-treatment-related reasons, either due to on-treatment failure defined as either non-response where HCV RNA is detected at end of treatment without HCV RNA \<LLOQ having been achieved while on treatment; rebound defined as \>1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ (target detected, quantifiable \[TD(q)\]) after being \<LLOQ previously while on treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks; or relapse post-treatment. where there is a confirmed HCV RNA ≥LLOQ \[TD(q)\] following end of all study therapy, after becoming undetectable (target not detected \[TND\]) at end of treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks.

Outcome measures

Outcome measures
Measure	HCV GT1 n=78 Participants Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 Participants Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 Participants Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 Participants Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 Participants Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 Participants Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Percentage of Participants With Virologic Failure	3.8 Percentage of participants	2.1 Percentage of participants	23.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	13.6 Percentage of participants

Adverse Events

HCV GT1

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

HCV GT2

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

HCV GT3

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

HCV GT4

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

HCV GT5

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

HCV GT6

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HCV GT1 n=78 participants at risk Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 participants at risk Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 participants at risk Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 participants at risk Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 participants at risk Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 participants at risk Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Cardiac disorders Acute coronary syndrome	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Abscess limb	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	1.3% 1/78 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Investigations Ammonia increased	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Investigations Glomerular filtration rate decreased	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	HCV GT1 n=78 participants at risk Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT2 n=47 participants at risk Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT3 n=61 participants at risk Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT4 n=56 participants at risk Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT5 n=18 participants at risk Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.	HCV GT6 n=22 participants at risk Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Metabolism and nutrition disorders Decreased appetite	3.8% 3/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	4.3% 2/47 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	4.9% 3/61 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	11.1% 2/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	2.6% 2/78 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	9.1% 2/22 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	3.8% 3/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	4.3% 2/47 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	3.3% 2/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	5.4% 3/56 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	11.1% 2/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	9.0% 7/78 • Number of events 9 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	6.6% 4/61 • Number of events 5 • Up to Week 14 All participants who received at least one dose of study treatment.	8.9% 5/56 • Number of events 6 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Toothache	1.3% 1/78 • Number of events 5 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	9.1% 2/22 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	5.1% 4/78 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	3.3% 2/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
General disorders Asthenia	6.4% 5/78 • Number of events 5 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	9.8% 6/61 • Number of events 6 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
General disorders Fatigue	17.9% 14/78 • Number of events 16 • Up to Week 14 All participants who received at least one dose of study treatment.	10.6% 5/47 • Number of events 5 • Up to Week 14 All participants who received at least one dose of study treatment.	8.2% 5/61 • Number of events 5 • Up to Week 14 All participants who received at least one dose of study treatment.	7.1% 4/56 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
General disorders Oedema peripheral	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Influenza	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	5.4% 3/56 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	2.6% 2/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	6.4% 3/47 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	3.3% 2/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	16.7% 3/18 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	3.8% 3/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Accidental overdose	2.6% 2/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Contusion	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Joint injury	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	16.7% 3/18 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Investigations Blood pressure increased	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 3/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	11.1% 2/18 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	11.1% 2/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	3.8% 3/78 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	6.6% 4/61 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	5.4% 3/56 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Nervous system disorders Headache	9.0% 7/78 • Number of events 11 • Up to Week 14 All participants who received at least one dose of study treatment.	10.6% 5/47 • Number of events 6 • Up to Week 14 All participants who received at least one dose of study treatment.	16.4% 10/61 • Number of events 13 • Up to Week 14 All participants who received at least one dose of study treatment.	14.3% 8/56 • Number of events 10 • Up to Week 14 All participants who received at least one dose of study treatment.	11.1% 2/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	4.5% 1/22 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Psychiatric disorders Depression	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	2.1% 1/47 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	4.9% 3/61 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 2/78 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	9.1% 2/22 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 1/78 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	4.3% 2/47 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	9.1% 2/22 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	1.8% 1/56 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	1.6% 1/61 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	3.6% 2/56 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	9.1% 2/22 • Number of events 2 • Up to Week 14 All participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/47 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/61 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	5.6% 1/18 • Number of events 1 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/78 • Up to Week 14 All participants who received at least one dose of study treatment.	6.4% 3/47 • Number of events 4 • Up to Week 14 All participants who received at least one dose of study treatment.	4.9% 3/61 • Number of events 3 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/56 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/18 • Up to Week 14 All participants who received at least one dose of study treatment.	0.00% 0/22 • Up to Week 14 All participants who received at least one dose of study treatment.

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. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER