New Hepatitis C Regimens Have Adherence Issues

Advances in treatment for chronic hepatitis C virus (HCV) have been breaking news in the last few years, with many guideline revisions to include direct-acting antiviral (DAA) protease inhibitors approved by the FDA.

Chronic HCV causes significant morbidity and mortality, and without better treatment, the societal and financial burden of disease will increase enormously. DAAs offer some advantages over peginterferon alfa (PEG) and ribavirin (RBV) therapy in terms of cure rate, efficacy, tolerability, and administration route.

Concerned about real-world treatment patterns, health care use, and costs among HCV patients receiving DAA-based therapies, a research team recently assessed factors associated with incomplete courses of therapy. Their study, which was published in the April 2015 issue of Journal of Managed Care and Specialty Pharmacy, indicates there is room for improvement.

The researchers used a US-based commercial claims database to identify adults with chronic HCV who filled prescriptions for boceprevir or telaprevir after May 13, 2011. This study required that patients take all prescribed drugs for the minimum required duration identified in current treatment guidelines and FDA-approved drug labeling.

The investigators identified 871 telaprevir and 284 boceprevir patients aged 54 years, on average. Many patients had cirrhosis (25% and 18% in the telaprevir and boceprevir arms, respectively). Decompensated cirrhosis was diagnosed in 9% of telaprevir and 7% of boceprevir patients, while HIV co-infection was reported in 1% of patients.

For teleprevir, the FDA approved 12 weeks of triple therapy plus 12 weeks of dual therapy. For boceprevir, the agency approved 3 weeks of lead-in therapy plus 24 weeks of triple therapy.

Nevertheless, approximately half of telaprevir patents and three-quarters of boceprevir patients failed to complete the minimum duration of therapy recommended in the products’ complete prescribing information.

Medical and drug-related costs were high, with telaprevir patients incurring $19,519 and boceprevir patient incurring $16,927 before the price of the drugs. The additional drug costs were $59,953 for boceprevir and $76,497 for telaprevir.

The findings align with other evidence that real-world DAA completion rates are lower than the approximately 60% to 70% rates reported in clinical trials. The researchers noted that patients who enroll in clinical trials are carefully selected and have access to additional resources that encourage patient adherence to medications. They concluded that better HCV treatment regimens are needed to improve and encourage adherence.