Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
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|ClinicalTrials.gov Identifier: NCT01808248|
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: SOF Drug: PEG Drug: RBV||Phase 2|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||December 2013|
Participants will receive SOF+PEG+RBV for 12 weeks.
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.
- Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 12 weeks ]The percentage of participants discontinuing any study drug due to an adverse event was summarized.
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants Experiencing On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]
On-treatment virologic failure was defined as:
- Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
- Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
- Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
- Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
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): NCT01808248
|United States, Texas|
|Alamo Medical Research|
|San Antonio, Texas, United States, 78215|
|Study Director:||Rob Hyland||Gilead Sciences|