New hep C guidelines endorse direct-acting anti-viral agents

Nearly all patients with chronic hepatitis C virus (HCV) infections should receive direct-acting anti-viral agents, according to updated guidelines by the American Association for the Study for Liver Diseases and the Infectious Diseases Society of America.

Based on expanded “real-world” experience with the tolerability and efficacy of newer HCV medications, the section of the website www.HCVguidelines.org on “When and in Whom to Initiate HCV Therapy” no longer includes tables that offer recommendations on how to prioritize patients for treatment.

“Recent cohort studies support high efficacy and safety of current recommended regimens in real-world clinical practice. As these reports are made public, they are reviewed and considered for incorporation into the guideline recommendations,” guidelines panelist Susanna Naggie, MD, associate professor of medicine at the Duke University School of Medicine in Durham, North Carolina, told Medical Economics. “Real-world clinical experience over the past year has provided overwhelming evidence of the safety and effectiveness of these regimens. For nearly all patients, the risk of treatment is vastly outweighed by the benefit.”

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New data suggest successful hepatitis C treatment that results in sustained virologic response benefits patients with mild liver disease. Previously, the guidelines had prioritized treatment with the direct-acting anti-viral agents for those with the greatest need, particularly those with severe liver disease.

Patients with short life expectancies unrelated to HCV infection are not recommended for treatment with these newer therapies, according to the updated guidelines.

There may still be a need to prioritize patients for treatment based on the cost of the new drugs and regional availability of the appropriate healthcare provider.

“As CDC-recommended screening for HCV is better incorporated into clinical practices across the country, we will need to find ways to expand HCV therapy access beyond subspecialty clinics and tertiary care referral centers,” says Naggie. “Expanding treatment into primary care clinics will significantly improve access, especially for patients in more rural areas. Complex patient populations, including those with severe liver disease and/or hepatic decompensation, chronic kidney disease and end-stage renal disease, and direct-acting antiviral failures requiring retreatment, are best referred for subspecialty care.”

She notes that patients without severe liver disease or other complicating co-morbidities can receive therapy for HCV in their communities. “The primary limitation is ensuring primary care providers have adequate training on HCV natural history, liver disease staging, and treatment decision making,” Naggie says. “Also, ensuring that primary care providers have access to an expert when complications arise is critical to ensure long-term success and safety for patients.”

Even with the high cost of newer HCV treatments, “cost-effectiveness studies of direct-acting antiviral agent combination regimens have generally shown incremental cost-effectiveness ratios within the range of other accepted medical practices,” Naggie says.

Many insurance companies have placed restrictions on access to direct-acting antiviral agents, which amounts to a hurdle for clinicians to get access to the drugs for their patients. Most pharmaceutical companies offer copay assistance for patients, so the majority of HCV patients pay no more than $5 per prescription, if their insurer agrees to cover the medication, she notes.