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(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat hepatitis.
The new approval is for Vosevi, which is a tablet that contains three medications: sofosbuvir, velpatasvir and voxilaprevir.
The FDA approved Vosevi to treat long-lasting hepatitis C virus (HCV) genotypes 1 through 6 in adults without liver disease or with mild liver disease.
This medication is the first to be approved for adults who have previously been treated with sofosbuvir or other medications that treat HCV by blocking a protein called NS5A.
HCV infection leads to inflammation of the liver and can result in the liver not working as it should. There are six distinct HCV genotypes (strains). Knowing the strain of the virus can help determine the best treatment option. The treatment recommendations for Vosevi will depend on which viral genotype is causing the infection.
Vosevi’s approval came after two clinical trials found that the majority of patients who received the medication had no detectable HCV in the blood three months after treatment. Finding no virus in the blood suggested that the study participants’ HCV infections had been cured.
Common side effects of Vosevi include headache, feeling tired, diarrhea and nausea. This medication is not to be taken at the same time as rifampin.
The approval of Vosevi was granted to Gilead Sciences Inc.
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