Hepatitis C virus (HCV) treatments based on Gilead Sciences’ Sovaldi (sofosbuvir) are faring just as well in the real world as in clinical trials, MedPage Today reports. Researchers analyzed data collected by the HCV-Target consortium, which has been following 2,063 people treated with Sovaldi–based regimens since mid-April. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.
The cohort includes 384 people who took Sovaldi with interferon and ribavirin, which the U.S. Food and Drug Administration (FDA) approved to treat those with genotypes 1 and 4 of the virus. Then there are 784 people treated with Sovaldi and Janssen’s Olysio (simeprevir), which was approved in October, but which many clinicians have prescribed off-label throughout the year. Lastly, there were 228 people who took Sovaldi, Olysio and ribavirin. Sixty percent of the overall cohort had cirrhosis.
Not all of the members of the cohort are 12 weeks past the end of treatment, so the researchers presented interim results at the conference. In order to be declared cured, someone with hep C must maintain an undetectable viral load for 12 weeks after completing therapy, known as achieving a sustained virologic response, or SVR12. The researchers presented data on the proportion of those who have achieved an SVR4, which means someone has maintained an undetectable viral load four weeks after completing treatment. According to their research, having an SVR4 meant a 94.4 percent to 98.2 percent likelihood of achieving an SVR12.
The researchers found that 85 percent of those with genotype 1 who took Sovaldi plus interferon and ribavirin achieved an SVR4, compared with 90 percent of those with genotype 2 who took Sovaldi plus ribavirin, and 89 percent for those with genotype 1 who took Sovaldi and Olysio, with or without ribavirin.
Ribavirin did not affect cure rates among those with genotype 1 who were treated with Sovaldi and Olysio.
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