HCV Cure: Sofosbuvir & Ribavirin for Hepatitis C

clinical-trial PMID: 24795201

Quick Summary: This research looked at how well the drugs sofosbuvir and ribavirin work to cure Hepatitis C (HCV). The study found that this combination is very effective for people with HCV genotypes 2 and 3, with different treatment lengths for each type.

What The Research Found

The study showed that sofosbuvir and ribavirin can effectively eliminate the Hepatitis C virus from the body.

For HCV Genotype 2: A 12-week treatment cured 93% of patients.

For HCV Genotype 3: A 24-week treatment cured 85% of patients.

Important Note: People with Genotype 3 who didn't have liver damage (cirrhosis) had a higher cure rate (91%) than those who did (68%).

Side Effects: The most common side effects were mild, including headaches, feeling tired, and itchy skin.

Study Details

Who was studied: 419 people with Hepatitis C, either new to treatment or who had tried treatment before. Some had liver damage (cirrhosis).

How long: Patients with Genotype 2 were treated for 12 weeks. Patients with Genotype 3 were treated for 24 weeks.

What they took: Patients took sofosbuvir (a pill taken once a day) and ribavirin (a pill taken twice a day, with the dose based on their weight).

What This Means For You

If you have Hepatitis C, this research shows that sofosbuvir and ribavirin can be a very effective treatment option. The length of treatment depends on the type of Hepatitis C you have. Talk to your doctor to see if this treatment is right for you.

Ask your doctor: Discuss your specific situation and the best treatment plan for your type of Hepatitis C.

Understand your genotype: Knowing your HCV genotype is crucial for determining the right treatment duration.

Consider liver health: If you have cirrhosis, your doctor may need to adjust your treatment plan.

Study Limitations

The study changed during the process, so some of the initial goals weren't fully met.

The study didn't compare different treatment lengths for Genotype 3 directly.

The study didn't look at how well the treatment worked over a very long time.

Key Findings

The study demonstrated that a 12-week course of sofosbuvir-ribavirin achieved a 93% sustained virologic response (SVR) in patients with HCV genotype 2, while extending treatment to 24 weeks in genotype 3 patients resulted in an 85% SVR. Notably, genotype 3 patients without cirrhosis had a 91% SVR compared to 68% in those with cirrhosis. Adverse events were generally mild, with headache, fatigue, and pruritus being most common.

Study Design

This was a randomized, controlled clinical trial (VALENCE trial, NCT01682720) conducted in 2014. It enrolled 419 patients with HCV genotype 2 (n=91) or genotype 3 (n=328) infection, including both treatment-naive and interferon-experienced individuals. The original design compared 12 weeks of sofosbuvir-ribavirin to placebo, but due to emerging phase 3 data, the protocol was modified: placebo arms were terminated, and genotype 3 patients received extended 24-week treatment. The study’s primary endpoint was SVR at 12 weeks post-treatment.

Dosage & Administration

Patients received oral sofosbuvir (400 mg once daily) plus weight-based ribavirin (1,000–1,200 mg daily, adjusted for body weight). Treatment duration varied: genotype 2 patients received 12 weeks, while genotype 3 patients were treated for 24 weeks. The regimen was administered in an open-label fashion after unblinding.

Results & Efficacy

Genotype 2: 93% SVR (68/73 patients; 95% CI: 85–98) with 12-week therapy.
Genotype 3: 85% SVR (213/250 patients; 95% CI: 80–89) with 24-week therapy.
Cirrhosis Subgroup: Genotype 3 patients without cirrhosis had a 91% SVR vs. 68% in those with cirrhosis.
Prior Interferon Treatment: 58% of participants were interferon-experienced, though efficacy outcomes were not stratified by this factor in the analysis.

Limitations

The study’s design shifted from hypothesis-testing to descriptive after unblinding, reducing statistical rigor.
Placebo-controlled data were limited to genotype 2 patients, as the placebo arm was terminated early for genotype 3.
Small genotype 2 sample size (n=91) compared to genotype 3 (n=328).
No direct comparison of 12-week vs. 24-week regimens in genotype 3 due to protocol changes.
Long-term safety and efficacy beyond 24 weeks were not assessed.

Clinical Relevance

The findings support sofosbuvir-ribavirin as an effective interferon-free regimen for HCV genotypes 2 and 3, particularly with extended 24-week treatment for genotype 3. Genotype 2 patients achieved high SVR rates in 12 weeks, while genotype 3 patients benefited more from prolonged therapy. These results align with subsequent real-world treatment guidelines, emphasizing genotype-specific durations. However, Uridine Monophosphate was not studied here, and this analysis pertains exclusively to antiviral therapy for HCV.

Note: This study does not evaluate Uridine Monophosphate. It focuses on sofosbuvir-ribavirin for hepatitis C treatment. The discrepancy between the user’s query and the provided study highlights the importance of verifying research details before application to supplement contexts.