HealthDay News — The FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic infection with hepatitis C.
It’s considered a breakthrough medication since it’s the first such drug that does not require same-time administration of interferon, the agency said in a news release.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Sofosbuvir is a nucleotide analog inhibitor designed to inhibit a protein that the virus needs to replicate. The drug’s safety and effectiveness were evaluated in clinical studies involving 1,947 people who had not previously received treatment or had not previously responded to treatment.
Results from all clinical trials showed a treatment regimen containing sofosbuvir was effective in treating multiple types of the hepatitis C virus.
The most common side effects reported by patients treated with sofosbuvir and ribavirin were fatigue and headache. The most common side effects reported by patients taking sofosbuvir, ribavirin, and peginterferon-alfa were fatigue, headache, nausea, insomnia and anemia.