TREATMENT OF HCV INFECTION

The American Association for the Study of Liver Diseases, along with other societies, has updated guidelines for the treatment of hepatitis C viral infection (HCV), including the use of direct-acting antiviral drugs. The new guidance was published onlineJune 25 in Hepatology and is also posted online.

According to World Health Organization estimates, worldwide prevalence of chronic HCV infection is approaching 150 million. The Centers for Disease Control and Prevention reported US prevalence of 2.7 million, with 30,000 new acute cases in 2013. Health burden of HCV includes complications of cirrhosis or hepatocellular carcinoma.

"The good news is that HCV is now on the cusp of being a curable disease for...millions of Americans, many of whom are undiagnosed," writing panel cochair Gary Davis, MD, president of MedLogician Consulting, said in a news release. "The web-based Guidance document is an easy-to-use resource for practitioners treating HCV patients with novel antivirals."

The writing panel included 26 specialists in hepatology and infectious disease, as well as a patient advocate, to address HCV testing and linkage to care, initial therapy of HCV infection in treatment-naive patients, retreatment for patients refractory to prior therapy, and data for unique patient populations.

According to newly available data presented at the European Association for the Study of the Liver International Liver Congress 2015, the panel updated sections on When and In Whom to Initiate Therapy, Initial Treatment, Retreatment, Acute HCV Infection, and Unique Populations (HIV/HCV Coinfection, Decompensated Cirrhosis, and Renal Impairment).

"The Guidance is a living document that will continually be updated with evidence-based advice about how to best use the next generation of direct-acting antivirals and other treatment options," said American Association for the Study of Liver Diseases President-elect Keith Lindor, MD, from Arizona State University, Tempe. "Our role as associations of researchers and clinicians is to provide key information in the appropriate format to patients and those who care for them."

Some of the specific updates include the following:

• All patients with chronic HCV infection should be treated with the exception of those with short life expectancies as a result of comorbid conditions.
• Based on available resources, patients at high risk for liver-related complications should be given high priority for immediate treatment.
• Treatment-naive patients with HCV genotype 1a or 1b infection should receive daily sofosbuvir (400 mg) plus simeprevir (150 mg) for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis without Q80K polymorphism), with or without weight-based ribavirin (from 1000 mg [<75 1200="" kg="" mg="" to="">75 kg]).
• Treatment-naive patients with HCV genotype 3 infection should receive daily sofosbuvir (400 mg) and weight-based ribavirin plus weekly peginterferon for 12 weeks or, alternatively, daily sofosbuvir and weight-based ribavirin for 24 weeks if they are interferon-eligible.
• Treatment-naive patients with HCV genotype 5 or 6 infection should receive a daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks or, alternatively, daily sofosbuvir and weight-based ribavirin plus weekly peginterferon for 12 weeks. Peginterferon and ribavirin with or without simeprevir for 24 to 48 weeks is not recommended.
• Patients with HCV genotype 1a or 1b infection without cirrhosis but with failure of prior peginterferon and ribavirin treatment should receive daily sofosbuvir (400 mg) plus simeprevir (150 mg) for 12 weeks.

Societies collaborating with the American Association for the Study of Liver Diseases to update these guidelines are the Infectious Diseases Society of America and the International Antiviral Society-USA.

Financial disclosures of the guidelines authors regarding various pharmaceutical companies are available online.