Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01826981 |
Recruitment Status :
Completed
First Posted : April 9, 2013
Results First Posted : September 16, 2016
Last Update Posted : November 16, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Drug: LDV/SOF Drug: SOF Drug: RBV Drug: Peg-IFN Drug: GS-9669 Drug: VEL | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 359 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)
LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Experimental: Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Drug: Peg-IFN pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
Other Name: Pegasys® |
Experimental: Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)
LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Experimental: Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)
LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: GS-9669 GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily |
Experimental: Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Experimental: Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Experimental: Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)
SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
Drug: VEL Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816 |
Experimental: Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)
SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Drug: VEL Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816 |
Experimental: Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)
SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
Drug: VEL Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816 |
Experimental: Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)
SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Drug: VEL Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816 |
Experimental: Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)
LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Experimental: Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)
LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
- Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks plus 30 days ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 1 and 2 ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 4, 6, and 8 ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 10 ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 12 ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 16, 20, and 24 ]
- Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24) [ Time Frame: Posttreatment Weeks 2, 4, 8, and 24 ]
- For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20) [ Time Frame: Posttreatment Weeks 16 and 20 ]
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
On-treatment virologic failure was defined as:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic genotype 1, 2, 3, or 6 HCV infection
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826981
New Zealand | |
Auckland Clinical Studies Ltd. | |
Auckland, New Zealand | |
Christchurch Clinical Studies Trust | |
Christchurch, New Zealand |
Study Director: | Robert H Hyland, DPhil | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01826981 |
Other Study ID Numbers: |
GS-US-337-0122 |
First Posted: | April 9, 2013 Key Record Dates |
Results First Posted: | September 16, 2016 |
Last Update Posted: | November 16, 2018 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | 18 months after study completion |
Access Criteria: | A secured external environment with username, password, and RSA code. |
URL: | http://www.gilead.com/research/disclosure-and-transparency |
Hepatitis C Hepatitis C, Chronic Infections Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections Communicable Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis, Chronic Sofosbuvir Antiviral Agents Anti-Infective Agents |