U.S.FDA approves Combination Drug Vosevi to treat Chronic Hepatitis C in Adults

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The US FDA has authorized a new drug to treat Chronic Hepatitis C in adults with genotypes 1-6 without cirrhosis or with benign cirrhosis. The new drug Voxolaprevir is a fixed dose, containing two other drugs named Sofosbuvir and Velpatasvir which are both pre-approved drugs. It is for the first time that treatment is approved for patients previously treated with direct-acting Sofosbuvir and other NS5A protein inhibiting drugs for HCV.

Edward Cox, M.D., the director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research stated in a statement, “Direct-acting antiviral drugs impede the virus from populating and often cure HCV. Vosevi offers a treatment option for some patients who were not favorably treated with other HCV drugs in the past.”

Recommended treatment for Vosevi is different depending on prior treatment history and viral genotype.

A headache, fatigue, diarrhea, and nausea are the most common adverse reactions in patients taking Vosevi.

It is contraindicated in patients taking the drug rifampin knowing the virus strain can help treatment recommendations. 75% of Americans have HCV genotype 1, 20 to 25% have genotype 2, or 3, and a small number of patients have 4, 5, or 6.

Results of both trials demonstrated that 96-97 percent of patients who received Vosevi had no virus discovered in the blood 12 weeks after finishing the treatment, suggesting that patients’ infection had been remedied.

96-97% of patients who received Vosevi in both trials demonstrated that they had no virus discovered in blood after 12 weeks of finishing the treatment.

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