William F. Balistreri, MD

Disclosures

March 22, 2016

In This Article

Treatment of HCV Genotype 3

Despite progress in the development of well-tolerated, all-oral, interferon-free therapies, the treatment of patients with HCV genotype 3 remains challenging. The optimal regimen and duration of treatment remain unclear, especially for treatment-experienced patients with cirrhosis.

Sofosbuvir and Ribavirin

In clinical trials, SOF/RBV resulted in higher SVR12 rates for patients with HCV genotype 2 than for those with genotype 3. However, higher SVR rates were obtained for patients with HCV genotype 3 if treatment was extended to 24 weeks.

Welzel and colleagues[8] investigated the safety and efficacy of SOF/RBV in patients with HCV genotype 3, including those who had previously received interferon-based therapy or had cirrhosis. Overall SVR12 rates were 85% for patients with HCV genotype 2 and 62% for HCV genotype 3. SVR was lowest in treatment-experienced patients with HCV genotype 3 and cirrhosis (43%). Common adverse events included anemia, nausea, headache, fatigue, and insomnia. The low response rates in patients with HCV genotype 3 indicate a need for better optimized treatment strategies

Daclatasvir Plus Sofosbuvir, With or Without Ribavirin

The combination of DCV and SOF administered for 12 weeks was associated with a high SVR12 rate in noncirrhotic patients with HCV genotype 3 (96%) and a lower SVR12 rate in patients with cirrhosis (70%).

In an ongoing multicenter compassionate use program in France, Hezode and colleagues[9] assessed 395 patients who received DCV (60 mg) plus SOF (400 mg) daily for 12 or 24 weeks, with RBV added at the physician's discretion in 21% of patients. Treatment duration was 24 weeks in 42% of patients and 12 weeks in 18%. SVR12 was achieved in 90% of patients, and no virologic breakthrough was observed. The optimal treatment duration for patients with cirrhosis was 24 weeks.

Welzel and colleagues[10] reported interim results from a trial investigating the efficacy of the combination of DCV plus SOF with or without RBV for the treatment of patients with HCV genotype 3. Infected patients were recruited from a European compassionate use program that enrolled patients with chronic HCV infection who were at high risk for hepatic decompensation or death within 12 months if left untreated and who had no available treatment options. Most patients had cirrhosis (81%); 56% were Child-Pugh class B or C, and 16% had Model for End-Stage Liver Disease (MELD) scores ≥ 15.

Each patient received a 24-week course of DCV (60 mg) plus SOF (400 mg) daily, with RBV added at the physician's discretion. Overall, SVR12 rates were 92%. However, there was a high rate of serious adverse events (eg, pneumonia, multiorgan failure, hepatic encephalopathy), which is expected in this high-risk population. The use of RBV did not affect efficacy outcomes in the DCV plus SOF studies.[9,10] [Editor's note: The FDA approved expanded use of DCV (Daklinza™, Bristol-Myers Squibb) for HCV in February 2016. The drug can now be used in combination with SOF (Sovaldi®, Gilead Sciences), with or without RBV, to treat patients with HCV genotype 1 and 3.]

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