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Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection
Mark S Sulkowski1, Susanna Naggie2, Jacob Lalezari3
1Viral Hepatitis Center, Johns Hopkins University, Baltimore, Maryland.
Insights
Sofosbuvir and ribavirin effectively treated hepatitis C virus (HCV) in patients with HIV coinfection, achieving high sustained virologic response rates without negatively impacting HIV disease or treatment.
Area of Science:
- Hepatology and Infectious Diseases
- Antiviral Therapy Research
- HIV/HCV Co-infection Management
Background:
- Hepatitis C virus (HCV) treatment in human immunodeficiency virus (HIV)-coinfected patients is challenging due to drug interactions and interferon-based therapies.
- Previous treatment options for HCV-HIV coinfection were limited, necessitating the exploration of interferon-free regimens.
Purpose of the Study:
- To evaluate the efficacy, measured by sustained virologic response (SVR), of sofosbuvir and ribavirin in patients coinfected with HCV and HIV.
- To assess the safety and adverse events associated with this oral, interferon-free treatment regimen in the target population.
Main Methods:
- An open-label, phase 3 trial involving 223 patients with HCV genotypes 1, 2, or 3 and concurrent HIV infection.
- Patients received either 12 or 24 weeks of sofosbuvir and weight-based ribavirin, depending on HCV genotype and treatment history.
- Eligibility required stable antiretroviral therapy (ART) for HIV or untreated HIV with specific CD4+ T-cell counts.
Main Results:
- High SVR12 rates were observed across HCV genotypes: 76% for genotype 1 (treatment-naive), 88% for genotype 2, and 67% for genotype 3 (treatment-naive).
- Treatment-experienced patients with HCV genotypes 2 or 3 also showed high SVR12 rates (92% and 94%, respectively).
- Common adverse events included fatigue, insomnia, and nausea; only 3% discontinued treatment due to adverse events, with no impact on HIV status.
Conclusions:
- The oral, interferon-free combination of sofosbuvir and ribavirin demonstrates high efficacy for HCV eradication in patients with HCV-HIV coinfection.
- This regimen offers a promising treatment option for HCV-HIV coinfected individuals, warranting further investigation in diverse populations.
- The treatment was well-tolerated and did not adversely affect HIV disease progression or management.
Importance:
Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.
Objective:
To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.
Design, Setting, And Participants:
Open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.
Interventions:
Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.
Main Outcomes And Measures:
The primary study outcome was the proportion of patients with SVR (serum HCV <25 copies/mL) 12 weeks (SVR12) after cessation of HCV therapy.
Results:
Among treatment-naive participants, 87 patients (76%) of 114 (95% CI, 67%-84%) with genotype 1, 23 patients (88%) of 26 with genotype 2 (95% CI, 70%-985), and 28 patients (67%) of 42 with genotype 3 (95% CI, 51%-80%) achieved SVR12. Among treatment-experienced participants, 22 patients (92%) of 24 with genotype 2 (95% CI, 73%-99%) and 16 patients (94%) of 17 (95% CI, 71%-100%) achieved SVR12. The most common adverse events were fatigue, insomnia, headache, and nausea. Seven patients (3%) discontinued HCV treatment due to adverse events. No adverse effect on HIV disease or its treatment was observed.
Conclusions And Relevance:
In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR12. Further studies of this oral regimen in diverse populations of coinfected patients are warranted.
Trial Registration:
clinicaltrials.gov Identifier: NCT01667731.
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