Trial Outcomes & Findings for A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (NCT NCT02993250)

Last Updated: 2019-09-11

Results Overview

An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)

Results posted on

2019-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Overall Study STARTED	22	11
Overall Study COMPLETED	22	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.	Total n=33 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	54.9 years STANDARD_DEVIATION 6.76 • n=7 Participants	57.8 years STANDARD_DEVIATION 9.98 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Number of Participants With Adverse Events (AEs)	15 participants	9 participants

SECONDARY outcome

Timeframe: Week 4 (follow-up phase)

SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment	100 Percentage of participants Interval 84.6 to 100.0	100 Percentage of participants Interval 71.5 to 100.0

SECONDARY outcome

Timeframe: Week 12 (follow-up phase)

SVR12 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment	100 Percentage of participants Interval 84.6 to 100.0	100 Percentage of participants Interval 71.5 to 100.0

SECONDARY outcome

Timeframe: Week 24 (follow-up phase)

Population: Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

SVR 24 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=10 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment	100 Percentage of participants Interval 84.6 to 100.0	90.9 Percentage of participants Interval 58.7 to 99.8

SECONDARY outcome

Timeframe: End of treatment up to Week 24 (follow up phase)

Population: Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\] and had at least 1 postbaseline efficacy measurement in this study.

Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA \< LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow-up.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With Viral Relapse	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: EOT up to Week 12 (follow up phase)

On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA \>= LLOQ (15 IU/mL) at the actual EOT.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With On-treatment Failure	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)

Percentage of participants with On-treatment Virologic Response with HCV RNA \< LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Percentage of Participants With On-treatment Virologic Response Day 2: < 15 IU/mL not detected	4.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Day 3: < 15 IU/mL not detected	4.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 1: < 15 IU/mL not detected	4.5 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 2: < 15 IU/mL not detected	22.7 Percentage of participants	45.5 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 3: < 15 IU/mL not detected	54.5 Percentage of participants	63.6 Percentage of participants
Percentage of Participants With On-treatment Virologic Response week 4: < 15 IU/mL not detected	72.7 Percentage of participants	72.7 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 6: < 15 IU/mL not detected	90.9 Percentage of participants	100 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 8: < 15 IU/mL not detected	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 10: < 15 IU/mL not detected	—	100 Percentage of participants
Percentage of Participants With On-treatment Virologic Response Week 12: < 15 IU/mL not detected	—	100 Percentage of participants

SECONDARY outcome

Timeframe: EOT up to Week 24 (follow up phase)

Time to Achieve HCV RNA not Detected or HCV RNA \<LLOQ (15 IU/mL) was reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 Participants Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 Participants Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ	19.0 Days Standard Deviation 1.68	18.6 Days Standard Deviation 3.86

Adverse Events

Cohort 1: Chronic Hepatitis C Without Cirrhosis

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 participants at risk Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 participants at risk Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Eye disorders Cataract	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].

Other adverse events

Additional Information

Clinical Leader

Janssen Pharmaceutical K.K., Japan

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1: Chronic Hepatitis C Without Cirrhosis n=22 participants at risk Participants received AL-335 800 milligram (mg) (2\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis n=11 participants at risk Participants received AL-335 800 mg (2\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Cardiac disorders Atrioventricular Block First Degree	9.1% 2/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Eye disorders Cataract	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Eye disorders Eye Discharge	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Gastrointestinal disorders Abdominal Pain Upper	9.1% 2/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	0.00% 0/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Gastrointestinal disorders Diarrhoea	13.6% 3/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	0.00% 0/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Gastrointestinal disorders Gastritis	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	18.2% 2/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Gastrointestinal disorders Gastrointestinal Motility Disorder	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
General disorders Malaise	9.1% 2/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	0.00% 0/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Infections and infestations Nasopharyngitis	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Infections and infestations Oral Herpes	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Infections and infestations Viral Upper Respiratory Tract Infection	4.5% 1/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	36.4% 4/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Investigations Alanine Aminotransferase Increased	9.1% 2/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	18.2% 2/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Investigations Aspartate Aminotransferase Increased	9.1% 2/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	18.2% 2/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Investigations Blood Cholesterol Increased	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Musculoskeletal and connective tissue disorders Neck Pain	4.5% 1/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Nervous system disorders Headache	13.6% 3/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	18.2% 2/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].
Skin and subcutaneous tissue disorders Eczema	0.00% 0/22 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].	9.1% 1/11 • Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\].