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FDA Approves Sofosbuvir (Sovaldi) for Treatment of Chronic Hepatitis C

Drug is third with breakthrough therapy designation to receive agency approval (December 6)

The FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic hepatitis C virus (HCV) infection. The drug is the first to demonstrate safety and efficacy in the treatment of certain types of HCV infection without the need for co-administration of interferon (IFN).

Sofosbuvir is the second drug approved by the FDA in the past few weeks to treat chronic HCV infection. On November 22, the FDA approved simeprevir (Olysio, Janssen Pharmaceuticals).

Sofosbuvir is a nucleotide analog inhibitor that blocks a specific protein needed by HCV to replicate. The drug is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include sofosbuvir and ribavirin or sofosbuvir, ribavirin, and pegIFN-alfa.

The clinical efficacy of sofosbuvir was evaluated in six studies involving a total of 1,947 participants who had not previously received treatment for their disease (treatment naïve) or had not responded to previous treatment (treatment experienced), including participants co-infected with HCV and human immunodeficiency virus (HIV). The trials were designed to determine whether HCV was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting that the participant’s HCV infection has been cured.

Sofosbuvir is the third drug with a breakthrough therapy designation to receive the FDA’s approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates that the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.

Source: FDA; December 6, 2013.

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