Hepatitis C & HIV: New Treatment Shows Promise

observational-study PMID: 25038354

Quick Summary: A study found that a new combination of medicines effectively treated Hepatitis C (HCV) in people also living with HIV. The treatment, which didn't use interferon, led to high cure rates and was well-tolerated.

What The Research Found

Researchers looked at how well a combination of two drugs, sofosbuvir and ribavirin, worked in people who had both Hepatitis C and HIV. They found that the treatment was very effective at getting rid of the Hepatitis C virus. Most people in the study were cured of HCV. The treatment also didn't seem to interfere with their HIV medications.

Study Details

Who was studied: 223 people with both Hepatitis C and HIV. Some had never been treated for HCV, while others had tried treatments before.

How long: The study lasted for 12 or 24 weeks, depending on the type of Hepatitis C they had.

What they took: Participants took sofosbuvir (400mg daily) and ribavirin (dose based on weight).

What This Means For You

If you have both Hepatitis C and HIV, this study suggests that a new treatment option is available that can effectively cure your Hepatitis C. This treatment doesn't use interferon, which can have many side effects. Talk to your doctor about whether this treatment might be right for you.

Study Limitations

The study wasn't a "gold standard" study. It didn't compare the treatment to a placebo (a "dummy" pill) or another treatment.

The study included a limited number of people, especially those who had tried HCV treatment before.

The study only followed people for a short time after treatment, so we don't know the long-term effects.

Key Findings

This 2014 observational study found that the interferon-free regimen of sofosbuvir (400 mg daily) and weight-based ribavirin achieved high sustained virologic response (SVR12) rates in patients coinfected with hepatitis C virus (HCV) and HIV. SVR12 rates were 76% for HCV genotype 1 (95% CI: 67%-84%), 88% for genotype 2 (95% CI: 70%-98%), and 67% for genotype 3 (95% CI: 51%-80%) among treatment-naive individuals. For treatment-experienced patients with genotype 2/3, SVR12 rates were 92% (95% CI: 73%-99%) and 94% (95% CI: 71%-100%), respectively. Adverse events (fatigue, insomnia, headache, nausea) were manageable, with only 3% discontinuing treatment. No negative interactions with antiretroviral therapies (ARTs) or HIV disease progression were observed.

Study Design

This was an open-label, nonrandomized, uncontrolled phase 3 trial conducted across 34 U.S. and Puerto Rico centers (August 2012–November 2013). The study included 223 participants with HCV genotypes 1, 2, or 3 and HIV coinfection. Eligibility criteria included stable ART with HIV RNA ≤50 copies/mL and CD4 >200 cells/μL, or untreated HIV with CD4 >500 cells/μL. Participants were stratified into treatment-naive (n=182) and treatment-experienced (n=41) groups based on HCV genotype and prior therapy.

Dosage & Administration

Treatment-naive patients with HCV genotype 1 and treatment-experienced patients with genotype 2/3 received sofosbuvir 400 mg daily plus weight-based ribavirin (1,000–1,200 mg/day) for 24 weeks. Treatment-naive genotype 2/3 patients received the same doses for 12 weeks. The regimen was administered orally, without interferon.

Results & Efficacy

Genotype 1 (treatment-naive): 76% achieved SVR12 (87/114; 95% CI: 67%-84%).
Genotype 2 (treatment-naive): 88% achieved SVR12 (23/26; 95% CI: 70%-98%).
Genotype 3 (treatment-naive): 67% achieved SVR12 (28/42; 95% CI: 51%-80%).
Genotype 2 (treatment-experienced): 92% achieved SVR12 (22/24; 95% CI: 73%-99%).
Genotype 3 (treatment-experienced): 94% achieved SVR12 (16/17; 95% CI: 71%-100%).
Adverse events were common but rarely led to discontinuation (7/223 patients). HIV viral load and CD4 counts remained stable, indicating no ART interference.

Limitations

The study lacked randomization, control groups, and blinding, increasing risk of bias. Genotype 2/3 treatment-experienced subgroups had small sample sizes (n=24 and n=17), limiting statistical power. Duration of follow-up was limited to 12 weeks post-treatment, with no long-term safety data. Demographics were not fully detailed, and the study excluded patients with advanced liver disease or lower CD4 counts, reducing generalizability.

Clinical Relevance

The findings demonstrate that sofosbuvir-ribavirin is effective and safe for HCV-HIV coinfected patients, particularly as an interferon-free alternative. High SVR12 rates across genotypes support its use in treatment-naive and experienced populations. However, the lack of randomization and narrow inclusion criteria highlight the need for larger, controlled trials in diverse groups. For clinicians, this regimen offers a viable option for coinfected patients without compromising HIV management.

Note: This study does not evaluate Uridine Monophosphate. The provided analysis focuses on sofosbuvir and ribavirin for HCV-HIV coinfection. Please verify the intended study for Uridine Monophosphate research.