Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
- Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed to treat the hepatitis C virus (HCV) infection. They are still being researched and are not approved by the Food and Drug Administration. They are being developed as treatment for hepatitis C as a single pill taken once a day.
- To determine whether a combination of the two study drugs can safely and effectively treat HCV infection in people with HIV infection and who do not have cirrhosis of the liver.
- Individuals who have HIV infection and have liver disease caused by infection with HCV.
- Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required.
- Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs.
- Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected With HIV|
- To assess the safety, tolerability and efficacy of a fixed dose combination (FDC) of GS-7977/GS-5885 tablets for 12 weeks in HIV/HCV GT-1 coinfected subjects who are IFN-treatment na(SqrRoot) ve. [ Time Frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 10,Week 2, Week 3, Week 4, Week 6, Week 8, Week 12, Week 14, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60 ] [ Designated as safety issue: Yes ]
- To assess the fitness of NS5A/B viral mutants in vivo in the presence or absence of a fixed dose combination of GS-7977/ GS-5885 in vitro by performing NS5A/B site directed mutagenesis. [ Time Frame: At study completion ] [ Designated as safety issue: No ]
- To compare HCV quasispecies evolution from baseline and throughout 12 weeks of treatment (especially during relapse or viral breakthrough) and assess the influence on virologic response to treatment in HIV/HCV GT-1 coinfected patients. [ Time Frame: At study completion ] [ Designated as safety issue: No ]
- To compare the immunologic, virologic and host genetic/proteomic predictors of response to treatment with a fixed dose combination of GS-7977/GS-5885 in subjects treated for 12 weeks. [ Time Frame: At study completion ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Subjects with HIV and HCV
Drug: GS-7977/GS- 5885 FDC
The GS-7977/GS-5885 FDC product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor and will be given for 12 weeks.
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the US an estimated 4.1 million people are infected with HCV which is the principal cause of death from liver disease and leading indication for liver transplantation. Significant advances have been made with the approval of directly acting antivirals (DAA) namely the protease inhibitors, telaprevir (TVR) and boceprevir (BOC) which have been shown to significantly improve rates of sustained virologic response (SVR). Response rates to these new combinations in HIV/HCV are also very promising, however treatment has been characterized with high rates of toxicities.
Recently several trials have confirmed the efficacy of potent DAA therapy without concomitant IFN in the treatment of HCV monoinfected individuals. Given the improved response rates achieved with a combination of DAAs with fast HCV suppression and improved side-effect profiles; and the need for better therapy for HIV/HCV co-infected subjects, we propose a study to determine the safety, tolerability and efficacy of 12 weeks of treatment with a fixed dose combination of GS-7977 and GS-5885 in HIV/HCV Genotype 1 (GT-1) subjects. We hypothesize that anti-HCV therapy that does not rely on the host immune system will provide an enhanced rate of SVR among HIV/HCV GT-1 coinfected subjects. The findings from this study will aid in our understanding of determinants of response to an IFN-free regimen in HIV/HCV coinfected individuals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878799
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Shyamasundaran Kottilil, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|