Trial Outcomes & Findings for Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (NCT NCT01329978)

NCT ID: NCT01329978

Last Updated: 2014-05-26

Results Overview

SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

332 participants

Primary outcome timeframe

Post-treatment Week 24

Results posted on

2014-05-26

Participant Flow

Participants were enrolled in a total of 42 study sites in the United States. The first participant was screened on 23 March 2011. The last participant observation was on 27 August 2012.

589 participants were screened and 332 were randomized and treated, and comprise the Safety Analysis Set.

Participant milestones

Participant milestones
Measure	SOF+PEG+RBV 12 Weeks Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Sofosbuvir+PEG+RBV Treatment Period STARTED	52	125	155	0	0
Sofosbuvir+PEG+RBV Treatment Period COMPLETED	48	112	150	0	0
Sofosbuvir+PEG+RBV Treatment Period NOT COMPLETED	4	13	5	0	0
Rerandomization Treatment Period STARTED	0	0	0	75	75
Rerandomization Treatment Period COMPLETED	0	0	0	70	71
Rerandomization Treatment Period NOT COMPLETED	0	0	0	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	SOF+PEG+RBV 12 Weeks Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Sofosbuvir+PEG+RBV Treatment Period Adverse Event	1	2	0	0	0
Sofosbuvir+PEG+RBV Treatment Period Lost to Follow-up	2	8	2	0	0
Sofosbuvir+PEG+RBV Treatment Period Withdrawal by Subject	1	1	3	0	0
Sofosbuvir+PEG+RBV Treatment Period Subject Was Incarcerated	0	1	0	0	0
Sofosbuvir+PEG+RBV Treatment Period Subject Moved Out of State	0	1	0	0	0
Rerandomization Treatment Period Lost to Follow-up	0	0	0	5	3
Rerandomization Treatment Period Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOF+PEG+RBV 12 Weeks n=52 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=125 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	Total n=332 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 9.8 • n=5 Participants	50 years STANDARD_DEVIATION 11.0 • n=7 Participants	50 years STANDARD_DEVIATION 10.8 • n=5 Participants	50 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	52 Participants n=7 Participants	49 Participants n=5 Participants	118 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	73 Participants n=7 Participants	106 Participants n=5 Participants	214 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants	67 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	99 Participants n=7 Participants	124 Participants n=5 Participants	265 Participants n=4 Participants
Ethnicity (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
Race/Ethnicity, Customized Black	2 participants n=5 Participants	17 participants n=7 Participants	16 participants n=5 Participants	35 participants n=4 Participants
Race/Ethnicity, Customized Not Black	50 participants n=5 Participants	108 participants n=7 Participants	139 participants n=5 Participants	297 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 1a	40 participants n=5 Participants	85 participants n=7 Participants	116 participants n=5 Participants	241 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 1b	12 participants n=5 Participants	24 participants n=7 Participants	39 participants n=5 Participants	75 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 4	0 participants n=5 Participants	11 participants n=7 Participants	0 participants n=5 Participants	11 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 6	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 6e	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Hepatitis C Virus (HCV) genotype Genotype 6o	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
HCV RNA	6.5 log10 copies/mL STANDARD_DEVIATION 0.66 • n=5 Participants	6.3 log10 copies/mL STANDARD_DEVIATION 0.73 • n=7 Participants	6.4 log10 copies/mL STANDARD_DEVIATION 0.79 • n=5 Participants	6.4 log10 copies/mL STANDARD_DEVIATION 0.75 • n=4 Participants
HCV RNA Category < 800,000 IU/mL	7 participants n=5 Participants	33 participants n=7 Participants	28 participants n=5 Participants	68 participants n=4 Participants
HCV RNA Category > 800,000 IU/mL	45 participants n=5 Participants	92 participants n=7 Participants	127 participants n=5 Participants	264 participants n=4 Participants
Liver Biopsy Fibrosis Score Missing	0 participants n=5 Participants	1 participants n=7 Participants	13 participants n=5 Participants	14 participants n=4 Participants
Liver Biopsy Fibrosis Score Bridging Fibrosis	7 participants n=5 Participants	17 participants n=7 Participants	23 participants n=5 Participants	47 participants n=4 Participants
Liver Biopsy Fibrosis Score None or Minimal Fibrosis	9 participants n=5 Participants	14 participants n=7 Participants	20 participants n=5 Participants	43 participants n=4 Participants
Liver Biopsy Fibrosis Score Portal Fibrosis	36 participants n=5 Participants	93 participants n=7 Participants	99 participants n=5 Participants	228 participants n=4 Participants
Alanine Aminotransferase (ALT)	80.5 U/L STANDARD_DEVIATION 71.61 • n=5 Participants	83.7 U/L STANDARD_DEVIATION 77.18 • n=7 Participants	76.4 U/L STANDARD_DEVIATION 55.91 • n=5 Participants	79.8 U/L STANDARD_DEVIATION 66.98 • n=4 Participants
ALT Category ≤ 1.5 × the upper limit of the normal range (ULN)	37 participants n=5 Participants	87 participants n=7 Participants	115 participants n=5 Participants	239 participants n=4 Participants
ALT Category > 1.5 × ULN	15 participants n=5 Participants	38 participants n=7 Participants	40 participants n=5 Participants	93 participants n=4 Participants
IL28b Genotype CC	13 participants n=5 Participants	36 participants n=7 Participants	39 participants n=5 Participants	88 participants n=4 Participants
IL28b Genotype CT	33 participants n=5 Participants	63 participants n=7 Participants	88 participants n=5 Participants	184 participants n=4 Participants
IL28b Genotype TT	6 participants n=5 Participants	26 participants n=7 Participants	28 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Post-treatment Week 24

Population: Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.

SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=52 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=109 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)	90.4 percentage of participants Interval 79.0 to 96.8	92.7 percentage of participants Interval 86.0 to 96.8	91.0 percentage of participants Interval 85.3 to 95.0	93.3 percentage of participants Interval 85.1 to 97.8	94.7 percentage of participants Interval 86.9 to 98.5

PRIMARY outcome

Timeframe: Baseline (Day 1) to post-treatment Day 30

Population: Safety Analysis Set

Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=52 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=125 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants Who Experienced Adverse Events Any AE	98.1 percentage of participants	96.8 percentage of participants	98.7 percentage of participants	98.7 percentage of participants	100.0 percentage of participants
Percentage of Participants Who Experienced Adverse Events Drug-related AE	96.2 percentage of participants	94.4 percentage of participants	97.4 percentage of participants	98.7 percentage of participants	97.3 percentage of participants
Percentage of Participants Who Experienced Adverse Events Grade 3 or higher AE	15.4 percentage of participants	17.6 percentage of participants	14.2 percentage of participants	14.7 percentage of participants	13.3 percentage of participants
Percentage of Participants Who Experienced Adverse Events AE leading to drug discontinuation	5.8 percentage of participants	16.0 percentage of participants	4.5 percentage of participants	5.3 percentage of participants	4.0 percentage of participants
Percentage of Participants Who Experienced Adverse Events Serious AE	3.8 percentage of participants	4.8 percentage of participants	2.6 percentage of participants	2.7 percentage of participants	2.7 percentage of participants

SECONDARY outcome

Timeframe: Post-treatment Week 12

Population: Participants in the Safety Analysis Set with available data were analyzed.

SVR12 was defined as HCV RNA \< LOD 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=52 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=125 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	90.4 percentage of participants Interval 79.0 to 96.8	92.0 percentage of participants Interval 85.8 to 96.1	91.0 percentage of participants Interval 85.3 to 95.0	93.3 percentage of participants Interval 85.1 to 97.8	94.7 percentage of participants Interval 86.9 to 98.5

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 2

Population: Participants in the Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=49 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=124 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=153 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Change in HCV RNA at Week 2	-5.12 log10 IU/mL Standard Deviation 0.660	-5.07 log10 IU/mL Standard Deviation 0.701	-5.13 log10 IU/mL Standard Deviation 0.768	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 4

Population: Participants in the Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=50 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=123 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=152 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Change in HCV RNA at Week 4	-5.33 log10 IU/mL Standard Deviation 0.649	-5.19 log10 IU/mL Standard Deviation 0.733	-5.24 log10 IU/mL Standard Deviation 0.785	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 8

Population: Participants in the Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=48 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=118 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=151 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Change in HCV RNA at Week 8	-5.34 log10 IU/mL Standard Deviation 0.635	-5.17 log10 IU/mL Standard Deviation 0.740	-5.25 log10 IU/mL Standard Deviation 0.789	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: Participants in the Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=47 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=113 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=150 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Change in HCV RNA at Week 12	-5.36 log10 IU/mL Standard Deviation 0.616	-5.20 log10 IU/mL Standard Deviation 0.719	-5.25 log10 IU/mL Standard Deviation 0.791	—	—

SECONDARY outcome

Timeframe: Week 2

Population: Participants in the Safety Analysis Set with Available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=51 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=124 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=153 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With HCV RNA < LOD at Week 2	68.6 percentage of participants	85.5 percentage of participants	77.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Participants in the Safety Analysis Set with Available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=50 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=123 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=153 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With HCV RNA Below < LOD at Week 4	98.0 percentage of participants	100.0 percentage of participants	98.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 8

Population: Participants in the Safety Analysis Set with Available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=48 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=118 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=152 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With HCV RNA Below < LOD at Week 8	100.0 percentage of participants	100.0 percentage of participants	99.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Safety Analysis Set with Available data were analyzed.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=47 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=113 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=150 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With HCV RNA Below < LOD at Week 12	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=100 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=68 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=74 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With HCV RNA Below < LOD at Week 24	—	100.0 percentage of participants	100.0 percentage of participants	98.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed.

ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at Week 12.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=23 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=47 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=71 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With ALT Normalization at Week 12	78.3 percentage of participants	76.6 percentage of participants	67.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 24

Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.

ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=38 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=35 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=30 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With ALT Normalization at Week 24	—	78.9 percentage of participants	94.3 percentage of participants	100.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Post-treatment Week 4

Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed.

ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=19 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=47 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=63 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=36 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=26 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With ALT Normalization at Post-treatment Week 4	89.5 percentage of participants	87.2 percentage of participants	95.2 percentage of participants	91.7 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 24

Population: Safety Analysis Set

Virologic failure was defined as either * HCV RNA ≥ 15 IU/mL after having previously had HCV RNA \< 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough); * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or * HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse) Baseline was Day 1 for all groups.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=52 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=125 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With Virologic Failure During Treatment Viral breakthrough	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Virologic Failure During Treatment Viral rebound	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Virologic Failure During Treatment Non-response	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: End of treatment to Post-treatment Week 24

Population: Participants in the Safety Analysis Set with available data were analyzed.

Viral relapse was defined as HCV RNA \< 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.

Outcome measures

Outcome measures
Measure	SOF+PEG+RBV 12 Weeks n=51 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=124 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=153 Participants Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.	SOF Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.	SOF+RBV Rerandomization Group n=75 Participants This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).	5.9 percentage of participants	1.6 percentage of participants	3.9 percentage of participants	2.7 percentage of participants	2.7 percentage of participants

Adverse Events

SOF+PEG+RBV 12 Weeks

Serious events: 2 serious events

Other events: 51 other events

Deaths: 0 deaths

SOF+PEG+RBV 24 Weeks

Serious events: 6 serious events

Other events: 121 other events

Deaths: 0 deaths

SOF+PEG+RBV 12 Week/Rerandomization Group

Serious events: 4 serious events

Other events: 153 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SOF+PEG+RBV 12 Weeks n=52 participants at risk Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.	SOF+PEG+RBV 24 Weeks n=125 participants at risk Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.	SOF+PEG+RBV 12 Week/Rerandomization Group n=155 participants at risk Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.65% 1/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Cardiac disorders Arrhythmia	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Gastrointestinal disorders Colitis iscaemic	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
General disorders Chest pain	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.65% 1/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Hepatobiliary disorders Chelocystitis acute	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.65% 1/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Hepatobiliary disorders Cholelithiasis	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.65% 1/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Infections and infestations Pyelonephritis	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Injury, poisoning and procedural complications Alcoohol poisoning	1.9% 1/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Injury, poisoning and procedural complications Road traffic accident	1.9% 1/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.80% 1/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.
Surgical and medical procedures Hip arthroplasty	0.00% 0/52 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.00% 0/125 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.	0.65% 1/155 • Baseline (Day 1) to Week 12 or Week 24 (depending upon treatment arm) plus 30 days. Adverse events are counted if they began on or after the date of the first dose and on or before the last dose of study drug plus 30 days. As prespecified in the analysis plan, adverse events are reported according to the group to which participants were initially randomized.

Other adverse events

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER