Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection (NCT NCT02023099)

NCT ID: NCT02023099

Last Updated: 2018-06-06

Results Overview

The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

363 participants

Primary outcome timeframe

12 weeks after the last dose of study drug

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Substudy 1, Arm A: DB 2-DAA Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis	Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Overall Study STARTED	215	106	42
Overall Study COMPLETED	212	106	39
Overall Study NOT COMPLETED	3	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Substudy 1, Arm A: DB 2-DAA Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Overall Study Non-fatal Adverse Event (AE)	0	1
Overall Study Withdrawn Consent	3	1
Overall Study Non-treatment-emergent Fatal AE	0	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Substudy 1, Arm A: DB 2-DAA n=215 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA n=106 Participants DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA n=42 Participants OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis	Total n=363 Participants Total of all reporting groups
Age, Customized < 65 years	129 participants n=5 Participants	59 participants n=7 Participants	21 participants n=5 Participants	209 participants n=4 Participants
Age, Customized ≥ 65 years	86 participants n=5 Participants	47 participants n=7 Participants	21 participants n=5 Participants	154 participants n=4 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	59 Participants n=7 Participants	22 Participants n=5 Participants	216 Participants n=4 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	47 Participants n=7 Participants	20 Participants n=5 Participants	147 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last dose of study drug

Population: Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=112 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment	94.6 percentage of participants Interval 90.5 to 98.8	—

SECONDARY outcome

Timeframe: up to 12 weeks

Population: Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).

On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following: * confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA \< LLOQ (rebound), or * confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or * HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress). The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=215 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA n=42 Participants OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment	0.5 percentage of participants Interval 0.1 to 2.6	2.4 percentage of participants Interval 0.4 to 12.3

SECONDARY outcome

Timeframe: up to 12 weeks

Population: ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A).

On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA \< 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=215 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-naïve: high BL viral load, IFN-eligible; n=112	0 percentage of participants Interval 0.0 to 3.3	—
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-naïve: low BL viral load; n=6	0 percentage of participants Interval 0.0 to 39.0	—
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-naïve: IFN-ineligible; n=23	0 percentage of participants Interval 0.0 to 14.3	—
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-exp. w/prior IFN-BT: relapser; n=22	0 percentage of participants Interval 0.0 to 14.9	—
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-exp. w/prior IFN-BT: nonresponder; n=28	0 percentage of participants Interval 0.0 to 12.1	—
Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation T-exp. w/prior IFN-BT: IFN-intolerant; n=26	3.8 percentage of participants Interval 0.7 to 18.9	—

SECONDARY outcome

Timeframe: within 12 weeks after last dose of study drug

Population: ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).

Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA \< LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=209 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA n=40 Participants OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in the Active Treatment Group With Post-treatment Relapse	2.4 percentage of participants Interval 1.0 to 5.5	5.0 percentage of participants Interval 1.4 to 16.5

SECONDARY outcome

Timeframe: within 12 weeks after last dose of study drug

Population: ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).

Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA \< 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA \< LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=209 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-naïve: high BL viral load, IFN-eligible; n=109	2.8 percentage of participants Interval 0.9 to 7.8	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-naïve: low BL viral load; n=6	0 percentage of participants Interval 0.0 to 39.0	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-naïve: IFN-ineligible; n=22	4.5 percentage of participants Interval 0.8 to 21.8	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-exp. w/prior IFN-BT: relapser; n=21	0 percentage of participants Interval 0.0 to 15.5	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-exp. w/prior IFN-BT: nonresponder; n=28	0 percentage of participants Interval 0.0 to 12.1	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation T-exp. w/prior IFN-BT: IFN-intolerant; n=25	4.0 percentage of participants Interval 0.7 to 19.5	—

SECONDARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).

Sustained virologic response (plasma HCV RNA level \< LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=215 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA n=42 Participants OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment	94.9 percentage of participants Interval 91.1 to 97.1	90.5 percentage of participants Interval 77.9 to 96.2

SECONDARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).

Sustained virologic response (plasma HCV RNA level \< LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA \< 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method.

Outcome measures

Outcome measures
Measure	Substudy 1, Arm A: DB 2-DAA n=215 Participants DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-naïve: all; n=139	94.2 percentage of participants Interval 89.1 to 97.1	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-naïve: high BL viral load, IFN-eligible; n=112	94.6 percentage of participants Interval 88.8 to 97.5	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-naïve: low BL viral load; n=6	100 percentage of participants Interval 61.0 to 100.0	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-naïve: IFN-ineligible; n=23	91.3 percentage of participants Interval 73.2 to 97.6	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-exp. w/prior IFN-BT: all; n=76	96.1 percentage of participants Interval 89.0 to 98.6	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-exp. w/prior IFN-BT: relapser; n=22	95.5 percentage of participants Interval 78.2 to 99.2	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-exp. w/prior IFN-BT: nonresponder; n=28	100 percentage of participants Interval 87.9 to 100.0	—
Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation T-exp. w/prior IFN-BT: IFN-intolerant; n=26	92.3 percentage of participants Interval 75.9 to 97.9	—

Adverse Events

Substudy 1, Arm A: DB 2-DAA

Serious events: 7 serious events

Other events: 116 other events

Deaths: 0 deaths

Substudy 1, Arm B: DB Placebo

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Substudy 1, Arm B: OL 2-DAA

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Substudy 2, Arm C: OL 2-DAA

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Substudy 1, Arm A: DB 2-DAA n=215 participants at risk DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis.	Substudy 1, Arm B: DB Placebo n=106 participants at risk DB placebo QD for 12 weeks in participants without cirrhosis	Substudy 1, Arm B: OL 2-DAA n=106 participants at risk OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis	Substudy 2, Arm C: OL 2-DAA n=42 participants at risk OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Eye disorders NECROTISING RETINITIS	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.94% 1/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.94% 1/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Infections and infestations ANAL ABSCESS	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Injury, poisoning and procedural complications TENDON RUPTURE	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.94% 1/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.94% 1/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER STAGE IV	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATOCELLULAR CARCINOMA	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	2.4% 1/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTOSIGMOID CANCER	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.94% 1/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Nervous system disorders MULTIPLE SCLEROSIS	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Renal and urinary disorders ANURIA	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	2.4% 1/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
Vascular disorders HYPOTENSION	0.47% 1/215 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/106 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.	0.00% 0/42 • AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.

Other adverse events

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