Read a concise review of a new real-world study that shows high efficacy for this all-oral combination against HCV GT2.
A combination of sofosbuvir plus ribavirin is safe and effective for the treatment of hepatitis C virus (HCV) genotype 2 (GT2) infection in a real-world, clinical practice setting, according to a new study.
HCV GT2 is the third most common genotype, with an estimated 16.5 million infected persons worldwide. Relative proportions of infections range from 10.8% and 12% in Western Europe and North America to higher prevalences in Central Latin America (19.3%), Western Sub-Saharan Africa (23.0%) and Asia Pacific (24.5%).
Previously, therapy with pegylated interferon (PegIFN) and ribavirin for 24 weeks yielded favorable response rates in HCV GT2-infected patients. However, poor tolerability limited the clinical use of PegIFN-based therapies, in particular in patients with liver cirrhosis, according to study authors led by Tania M Welzel of JW Goethe University Hospital, Frankfurt am Main, Germany.
The researchers published their results in October 2017 Gut.
The safety and efficacy of sofosbuvir in combination with weight-based ribavirin for 12 weeks in HCV GT2 patients has been tested in several pivotal phase III trials with good results. In these trials, 94% of patients without cirrhosis and 90% of patients with cirrhosis achieved a sustained virologic response 12 weeks after therapy (SVR12).
Welzel and colleagues set out to investigate the effectiveness and tolerability of sofosbuvir and ribarivin for treatment of HCV GT2 in HCV-TARGET, an international, prospective observational academic consortium study, designed to evaluate information on novel direct-acting antiviral (DAA) therapies used in routine patient care.
The study was conducted at 44 academic and 17 community medical centers in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice.
Of the 321 patients, 283 patients completed 12 weeks and 38 patients completed 16 weeks of treatment with sofosbuvir and ribavirin. Prior treatment experience and cirrhosis was more frequent among those who took the combination for 16 weeks as compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively).
Effective with/without cirrhosis
Overall, 88.2% of patients achieved SVR12. The SVR12 in patients without cirrhosis was 91% for 12 weeks of therapy and 92.9% for 16 weeks of therapy. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79% and 83%.
SVR12 rates in patients without cirrhosis were comparable with those reported in phase III clinical trials, they stated. A multivariate analysis showed liver cirrhosis, lower serum albumin and ribavirin dose at baseline were significantly associated with SVR12.
Both treatment durations were well-tolerated. Common adverse events included fatigue, anemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to adverse events occurred in 2.8% of patients. Serious adverse events were reported in less than 5% of patients.
Larger, randomized trials in patients with cirrhosis are required to determine the benefit of extended treatment durations of this combination for these patients, they concluded.
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