A new hepatitis C virus (HCV) treatment is expected to appear in pharmacies soon following US Food and Drug Administration's (FDA) decision to approve Vosevi, an HCV treatment developed by Gilead Sciences, Inc. The drug was cleared to treat adults with chronic HCV genotypes 1-6 with no cirrhosis, or mild cirrhosis.
Vosevi is a fixed dose combination product, containing three active ingredients: sofosbuvir, velpatasvir and voxilaprevir. Voxilaprevir is a new HCV nonstructural (NS) protein 3/4A protease inhibitor, the same drug class as medications such as asunaprevir and boceprevir. Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) was granted Priority Review and Breakthrough Therapy designations by the FDA. Breakthrough Therapy designation is designated to expedite development and review of drugs that could treat serious conditions and where clinical evidence indicates the drug may be substantially better than currently available therapies.
Approval was granted following two Phase 3 clinical trials demonstrating the safety and efficacy of Vosevi. These enrolled approximately 750 patients without cirrhosis or with mild cirrhosis. The first trial compared 12 weeks of treatment with Vosevi with 12 weeks of placebos in adults who previously failed treatment with an NS5A inhibitor drug, while the second looked at the efficacy of Vosevi compared with treatment using sofosbuvir and velpatasvir in adults with genotypes 1, 2 or 3 who had previously failed treatment with sofosbuvir, but not an NS5A inhibitor drug.
Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, commented: "Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past."
Who can take Vosevi?
Vosevi is the first treatment approved for patients who have already been treated with the direct-acting antiviral sofosbuvir or other HCV medications inhibiting the NS5A protein, such as Sovaldi (sofosbuvir). Treatment recommendations vary according to viral genotypes and treatment history, so patients should consult with their physicians over the suitability of the drug as part of the HCV treatment.
Vosevi is contraindicated in patients taking drugs containing rifampin, such as Rifater, Rifamate, Rimactane and Rifadin.
Common Side Effects of Vosevi
The most common adverse reactions in the trials were headaches, fatigue, diarrhea and nausea. The drug also carries the risk that a prior hepatitis B infection will be reactivated, so patients should be checked for hepatitis B infection before starting a course of treatment. Other potentially serious side effects include bradycardia (slow heart rate), particularly when taken in combination with drugs containing amiodarone, such as Cordarone, Nexterone and Pacerone.
About Hepatits C
Hepatitis C is a blood-born liver infection caused by the HCV virus. In the majority of cases it is a short-term and treatable condition, but in 15-30 percent of cases it can become a long-term, chronic infection. Figures from the Centers for Disease Control and Prevention (CDC) estimate between 2.7 million and 3.9 million people in the US have chronic hepatitis C. Currently, there is no vaccine against hepatitis C, but it is a treatable condition.
