Recent FDA-approval of AbbVie’s Viekira Pak is changing the hepatitis C treatment landscape. The first change to occur was an update by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) to their hepatitis C treatment guidelines, Recommendations for Testing, Managing, and Treating Hepatitis C.
Revisions were made to the following sections of the hepatitis C treatment guidelines:
- Initial Treatment of HCV Infection in Patients Starting Treatment
- Retreatment of Persons in Whom Prior Therapy Has Failed
- Monitoring Patients Who Are Starting Hepatitis C Treatment, Are on Treatment, or Have Completed Therapy
- Unique Patient Populations: Patients with HIV/HCV Coinfection
- Unique Patient Populations: Patients with Cirrhosis
- Unique Patient Populations: Patients Who Develop Recurrent HCV Infection Post-Liver Transplantation
- Unique Patient Populations: Patients with Renal Impairment
Here are highlights of some of the changes:
- Additional HCV treatment medications were added for genotypes 1 and 4, including Viekira Pak (combination of paritaprevir/ritonavir/ombitasvir plus twice-daily dosed dasabuvir with and without ribavirin)
- Updates were made to the Olysion/Sovaldi (simeprevir/sofosbuvir) regimen
- For the first time, there are different treatment options for genotype 1a versus genotype 1b
- Treatment for genotype 1 using Sovaldi (sofosbuvir) and ribavirin was moved to the Not Recommended list
- Under the Retreatment of Persons in Whom Prior Therapy Has Failed section, additional HCV treatment medications were added for genotypes 1 and 4, including Viekira Pak (Combination of paritaprevir/ritonavir/ombitasvir plus twice-daily dosed dasabuvir with and without ribavirin)
- The section about monitoring people on hepatitis C treatment was extensively revamped. In particular, there are recommendations for discontinuation of treatment because of lack of efficacy. If quantitative HCV viral load is detectable at week 4 of treatment, a repeat viral load test is recommended at week 6 of treatment. If viral load has increased by greater than 10-fold, then discontinuation of HCV treatment is recommended.
- With the approval of ribavirin-free HCV treatment, women who are pregnant may be treated, albeit little is known about treating this population.
- The same treatments for HCV mono-infection are recommended for people who are coinfected with HIV/HCV. This is interesting as Harvoni (sofosbuvir/ledipasvir) did not get an official FDA indication for this, despite stellar results in studies on treating HIV/HCV coinfection.
- Extensive lists of drugs and supplements that may interact with HCV drugs are listed, particularly in the Unique Patient Populations: Patients with HIV/HCV Coinfection section.
- Numerous options for treating people with cirrhosis (pre and post-transplant) are described, including options for those with decompensated cirrhosis.
- Specific HCV treatment recommendations were made for people with renal (kidney) disease.
For more about the AASLD/IDSA HCV guidelines, including how they are used to determine insurance coverage, read The Latest Hepatitis C Recommendations: Who Decides Your Future?
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