November 11, 2013

HCV Update: Simeprevir and Sofosbuvir

...Researchers found that a new pill that combines two drugs, sofosbuvir and ledipasvir, which would be taken over a much shorter time frame (12 weeks), was successful in essentially eliminating the strain of hepatitis C that is currently untreatable. "Our data lend support to the possibility of effectively treating all patients with genotype-1 HCV with a brief, all-oral, once-daily regimen that has no known safety issues," the study says. http://www.usnews.com/news/articles/2013/11/05/new-pill-may-help-those-with-untreatable-hepatitis-c == Unlike previous HCV treatments, which sought to enhance the immune system with interferon and other drugs, the latest group of oral medications interferes with the virus’s ability to replicate and make proteins. A US Food and Drug Administration (FDA) board recommended two such drugs—simeprevir, made by Johnson & Johnson in New Brunswick, New Jersey, and sofosbuvir from Gilead Sciences in Foster City, California—for approval last week. When each is taken in combination with a drug called ribavirin, the treatment eliminates hepatitis C in around 80 percent of people. “This is the first time in the history of humankind that we have a cure for a viral disease,” says pharmacologist Raymond Schinazi of Emory University in Atlanta, Georgia. http://www.scientificamerican.com/article.cfm?id=us-to-approve-potent-oral-drugs-for-hepatitis-c === Among the new drugs, the one garnering the most excitement is sofosbuvir, from Gilead Sciences, which is expected to be approved by the Food and Drug Administration by Dec. 8. It inhibits the virus’s polymerase enzyme, which builds new genomes out of RNA so the virus can replicate. Sofosbuvir is an evil decoy of sorts. It looks like a building block of RNA. But once it is mistakenly incorporated into the RNA chain, the chain cannot grow and the virus cannot reproduce. The effectiveness of the new drugs can vary depending on which strain of hepatitis C, known as genotypes, the patient has. People infected with hepatitis C genotypes 2 and 3 — which account for 20 to 25 percent of cases in the United States — will take sofosbuvir with ribavirin but without interferon, making this the first all-oral treatment for hepatitis C. Treatment for genotype 2 will be 12 weeks, but for genotype 3 it will probably be 24 weeks. Genotype 1, which accounts for more than 70 percent of patients in the United States, will still require interferon and ribavirin along with sofosbuvir, but only for 12 weeks. In a clinical trial, about 90 percent of previously untreated patients taking this combination achieved a sustained virologic response. The combination is expected to be somewhat less effective in those for whom previous treatments did not work. http://www.nytimes.com/2013/11/05/health/hepatitis-c-a-silent-killer-meets-its-match.html

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