FDA Approves a Triple-Combination Drug for Chronic Hepatitis C Treatment

On 18 July 2017, the American Food and Drug Administration FDAapproved the drug named below to treat adult patients with chronic hepatitis C virus (HCV) genotype 1-6 infection who have no cirrhosis (chronic liver failure) or mild cirrhosis: Vosevi .

Vosevi is a fixed-dose combination tablet containing two previously approved drugs, sofosbuvir and velpatasvir, and a new drug, voxilaprevir. It contains the triple combination of 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg voxilaprevir.

What Is Hepatitis C?

Hepatitis C infection is a viral disease that can cause inflammation of the liver, reduced liver function, liver cancer , or liver failure. In the United States alone, an estimated 2.7 to 3.9 million people have chronic HCV (hepatitis C virus) infection. In some patients, chronic HCV infection can lead to jaundice (yellowing of the eyes or skin), bleeding, abdominal fluid buildup, infections, and liver cancer.

There are at least six genetically distinct types of HCV. Knowing the viral type can help guide treatment recommendations. Approximately 75 percent of Americans with HCV have genotype 1, 20-25 percent have genotype 2 or 3, and a small number have genotype 4, 5, or 6.

Vosevi’s safety and efficacy were assessed in two phase 3 clinical trials involving approximately 750 adults with no cirrhosis or mild cirrhosis.

The first trial compared 12 weeks of Vosevi with placebo, a treatment containing no active ingredient, in adults with genotype 1 whose previous treatment with an NS5A inhibitor had failed. All patients with genotypes 2, 3, 4, 5, or 6 received Vosevi.

The second trial compared 12 weeks of Vosevi with the previously approved drugs sofosbuvir and velpatasvir in adults with genotypes 1, 2, or 3 whose previous sofosbuvir treatment had failed but who had not experienced treatment failure with an NS5A inhibitor.

The results of both trials showed that in 96-97% of patients receiving Vosevi, no virus was detectable in the blood 12 weeks after treatment ended, suggesting that their infections had been cured. This is an important achievement. Some scientists believe that hepatitis C infection could become completely treatable within the next 10 years.

Recommended Vosevi treatment doses can vary according to viral genotype and previous treatment history, but treatment generally consists of a tablet taken by mouth once daily for 12 weeks. The most common side effects in patients taking Vosevi are headache, fatigue, diarrhea, and nausea.

Vosevi must not be used in patients taking rifampin; it is contraindicated. In addition, before starting Vosevi, all patients should be screened for evidence of current or previous hepatitis B virus (HBV) infection because HBV can reactivate during Vosevi treatment.