Dive Brief:
- In a study of 223 people co-infected with HIV and hepatitis C (HCV) genotype 1, patients treated with Gilead’s Sovaldi (sofosbuvir) and ribavirin had a 76% sustained viral response (SVR) at 24 weeks.
- There were no severe adverse events detected during the initial study period.
- In patients with HCV genotype 3, SVR was substantially higher in treatment-experienced patients at 24 weeks versus 12 weeks (94% vs 67%).
Dive Insight:
Sovaldi continues to perform well in a variety of clinical trials, reinforcing the widespread assumption that this product is on its way to becoming a $10 billion drug and the biggest selling medicine in the world.
The implications of the study are that the combo of Sovaldi and ribavirin can be administered with any number of antiretroviral drugs. In addition, this combo regimen may be an ideal solution for treating patients for whom interferon is not a recommended treatment option.
One major caveat: patients with cirrhosis made up just 10% of trial participants while women made up just 17%, and patients with advanced HIV were also relatively underrepresented.