Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV.
- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections.
- Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV
- Half of the study participants will also have HIV infection.
- Participants will be screened with a medical history and physical exam. They will also have blood and urine tests.
- Participants will also have heart and liver function tests, and answer questions about mood and depression.
- Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly.
- Two weeks after starting treatment, participants will have blood tests to study the treatment.
- Four weeks after starting treatment, participants will start taking boceprevir three times a day.
- Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.
Drug: Peg-Interferon-alfa 2B
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, On-Treatment Trial to Assess the Effect of HIV-1 Coinfection on Therapeutic Responses Using Boceprevir, Peg-Interferon-alfa-2b and Ribavirin in HCV Genotype 1, IFN Treatment-Naive Subjects With or Without HIV-1|
- Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment. [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]
- Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects [ Time Frame: Day 0, Day 7 ] [ Designated as safety issue: No ]
- Safety and Treatment Outcome Measures Stratified by ESA Use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
- Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1-HCV
Hepatitis C Mono-infected
|Drug: Boceprevir Drug: Peg-Interferon-alfa 2B Drug: Ribavirin|
Active Comparator: 2 HCV/HIV
Hepatitis C and HIV co-Infected
|Drug: Boceprevir Drug: Peg-Interferon-alfa 2B Drug: Ribavirin|
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States, an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. A combination of ribavirin (RBV) and pegylated interferon (peg-IFN) is the currently recommended therapy for chronic HCV infection. However, this therapy achieves viral clearance in only 19% to 52% of patients infected with HCV genotype 1 and 76% to 80% of patients infected with genotypes 2 and 3. Current therapy is also associated with a high incidence of adverse events and low cure rates in several populations. Novel therapies that do not rely on an interferon backbone will be required to enhance cure rates in various populations. Recent data show that adding an HCV serine protease inhibitor (such as boceprevir [BOC]) to peg-IFN and RBV results in HCV eradication rates of 70% to 80% among HCV-monoinfected subjects. However, whether human immunodeficiency virus (HIV)-infected subjects will have similar rates of response to triple combination therapy is presently not known. Previous data have suggested that HIV-infected patients with chronic HCV infection have much lower eradication rates to peg-IFN and RBV than HCV-monoinfected subjects. This study will explore whether HIV/HCV-coinfected subjects have a lower response rate to a BOC/peg-IFN/RBV regimen than HCV-monoinfected subjects. Participants who have chronic hepatitis C genotype 1 monoinfection (N=50) or coinfection with HIV-1 (N=50), and who are na(SqrRoot) ve to IFN-based HCV treatment, will receive combination therapy with BOC (800 mg three times a day, every 7 to 9 hours, with food), weekly peg-IFN alpha-2b (1.5 mcg/kg/week) and twice daily RBV (weight based) for a maximum of 44 weeks, after a 4-week lead-in of peg-IFN and RBV. BOC received recent FDA approval for treating HCV monoinfection in combination with peg-IFN and RBV, and the approved labeling will be followed in this study. The primary endpoint is comparative efficacy in HCV-monoinfected and HIV/HCV-coinfected subjects. Secondary endpoints include determination of host predictors for therapeutic response, emergence of resistance biomarkers, and early viral kinetics. The findings from this study will aid in the understanding of whether HIV infection affects HCV antiviral and host responses to combination therapy using BOC/peg-IFN alfa-2b/RBV.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443923
|United States, District of Columbia|
|Unity Health Care, Inc./DC General|
|Washington, DC, District of Columbia, United States, 20002|
|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)|