Chronic hep C: More effective, better-tolerated therapies still needed, researchers say

June 13, 2014

Future therapies for chronic hepatitis C that have greater tolerability, simplified dosing schedules, shorter treatment duration, and more favorable safety profiles are needed to improve adherence and enhance treatment effectiveness, according to an abstract published in Value in Health. Treatments with fewer contraindications are also needed to expand available treatments to more patients in need of effective therapy.

Future therapies for chronic hepatitis C that have greater tolerability, simplified dosing schedules, shorter treatment duration, and more favorable safety profiles are needed to improve adherence and enhance treatment effectiveness, according to an abstract published in Value in Health. Treatments with fewer contraindications are also needed to expand available treatments to more patients in need of effective therapy.

The data were recently presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting in Montreal, Quebec, Canada.

Chronic hepatitis C is associated with substantial morbidity and mortality. In 2011, the approval of 2 direct-acting antiviral (DAA) agents, telaprevir and boceprevir, represent the first generation of oral DAA agents that have significantly improved the efficacy of treatment in genotype 1-infected individuals.

“However, these treatment regimens are complex; both telaprevir and boceprevir must be taken multiple times a day and both still require peginterferon alfa, administered via a weekly subcutaneous injection, and ribavirin, a twice-daily oral therapy,” said a study author Eric Qiong Wu, PhD, managing principal at Analysis Group. Wu is a health economist who practices in the areas of health economics, outcomes, and comparative effectiveness. 

“Both telaprevir and boceprevir are associated with their own unique side effects in addition to the significant side effects associated with peginterferon alfa and ribavirin treatment, such as anemia and rash,” he said.

Using a large commercial insurance claims database, Wu and colleagues conducted 2 studies investigating chronic hepatitis C patients in the real-world.

 

The first study assessed the treatment patterns, healthcare utilization, and costs of chronic hepatitis C patients treated with either of these DAA-based therapies.

“We found that chronic hepatitis C patients receiving these DAAs incurred substantial healthcare costs and utilization,” he said.

On average over the 12 months following treatment initiation, patients initiating a telaprevir regimen had approximately $19,500 in medical costs and $76,500 in drugs costs, and patients initiating a boceprevir regimen had approximately $17,000 in medical costs and $60,000 in drug costs, according to Dr Wu. Chronic hepatitis C drug costs accounted for approximately 91% of the drug costs of telaprevir and 85% of boceprevir patients. During this time period, patients had on average 29 to 30 outpatient visits, and approximately 17% had an inpatient visit and 28-30% had an ER visit.

“This study also revealed high noncompletion rates of the DAA-based therapy regimen,” Dr Wu said.

Approximately 54% of telaprevir and 74% of boceprevir patients failed to meet the minimum recommended therapy duration. Further, more than half of telaprevir and boceprevir patients had anemia and 10% to 14% had rash in the 12 months following initiation.

In the second study, the researchers investigated the presence of contraindications to ribavarin and peginterferon alpha, what Wu called, “the “backbone” of current therapy for genotype 1 chronic hepatitis C, among chronic hepatitis C patients not receiving treatment (DAAs, peginterferon, ribavirin).

“We found that over 60% of untreated chronic hepatitis C patients had diagnoses for contraindicated conditions, with arterial hypertension, hepatic decompensation, major system impairment, and psychiatric depression being the most common contraindications,” he said.