The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have released updated guidelines on their website for the treatment of hepatitis C virus infection, according to a press release.
Multiple sections of the guidance — posted on HCVguidelines.org — have been revised to reflect the FDA’s approval of Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) for all chronic HCV genotypes in adults. The combination drug was approved in June for patients with HCV regardless of cirrhosis status.
“We believe that the updated recommendations will help caregivers with regimen choice, not only in common treatment scenarios, but will also importantly provide guidance in cases where randomized trial data or specific FDA labeling may be lacking,” Raymond Chung, MD, co-chair of the HCV Guidance panel, said in the release.
The guidelines include the recommendation of a daily, fixed-dose combination of 400 mg sofosbuvir and 100 mg velpatasvir for 12 weeks for treatment-naive patients with HCV genotypes 1 through 4 with or without compensated cirrhosis. For patients with genotypes 5 and 6, the same combination is recommended for treatment-naive patients regardless of cirrhosis status. For patients with moderate to severe cirrhosis, the combination is approved with ribavirin.
The update also includes clinical trial data for other combination regimens of direct-acting antivirals to treat unique or harder-to-treat patient populations, including those with impaired kidney function, HIV coinfection or those who have undergone liver transplantation, according to the release.
“The latest updates … bring a trusted document up to date with the latest therapeutic options,” Hugo Vargas, MD, chair of the division of hepatology and professor of medicine at Mayo Clinic College of Medicine, and HCV Guidance panel co-chair, said. “The guidance now offers more than one front-line regimen for each viral genotype and updates recommendations for patients of high complexity. Most treating clinicians will find workable treatment options for the majority of their patients.”
HCV Next Editorial Board member Arthur Kim, MD, FIDSA, assistant professor of medicine at Harvard Medical School, and guidance panel co-chair, said the updated guidance will enable more providers to “join the fight against this deadly disease” and epidemic.
AASLD/ISDA. Recommendations for testing, managing, and treating hepatitis C. http://hcvguidelines.org/sites/default/files/HCV-Guidance_July_2016_b.pdf Accessed July 22, 2016.