Provided by the AGA Journals Blog
Less than 20% of patients infected with the most common Hepatitis C virus (HCV) genotype receive the latest drugs approved by the US Food and Drug Administration (FDA), according to the August issue of Clinical Gastroenterology and Hepatology. This low percentage could result from concerns of side effects or patient hopes that more effective medications will soon become available.
The anti-HCV drugs boceprevir and telaprevir, approved by the FDA in May 2011, were found to be highly effective in phase 3 clinical trials. When one of these drugs is given in combination with pegylated interferon and ribavirin (triple therapy), rates of sustained virologic response are 70%–80% in patients with HCV genotype 1 infection. Furthermore, these drugs have been reported to reduce mortality from liver diseases, including hepatocellular carcinoma, hepatocellular failure, and complications of portal hypertension.
Emerson Chen et al. investigated how many patients with HCV genotype 1 infection actually started this treatment regimen within the 12 months after their FDA approval.
They found that only 18.7% of patients seen at hepatology practices in Dallas and Miami from June 2011 through February 2012 began the triple therapy–about the same percentage as those receiving dual therapy (with only pegylated interferon and ribavirin) before boceprevir and telaprevir were approved. So, rates of treatment with triple therapy have not increased beyond levels seen in the prior decade with dual therapy, despite the proven efficacy of the new agents.
In analyzing patients’ charts, Chen et al. found that the reasons patients were not given the triple therapy included contraindications (in 50.5%, including non-hepatic disorders, decompensated liver disease, and adverse events during prior treatment), patient choice (22.5%), and less-advanced liver disease (17.4%).
Among the patients who did receive triple therapy, 15% discontinued prematurely because of serious adverse events such as anemia, dehydration, and rash.
Treatment experience and the extent of liver fibrosis seemed to be the most important determinants for initiation of triple therapy.
Patients who had HCV relapse after previous treatments are prime candidates for triple therapy, compared with prior non-responders and treatment-naive patients. Chen et al. found that patients with stage 3−4 fibrosis were also considered prime candidates for triple therapy—they have the highest risk for disease progression and development of liver-related complications.
The factors that affected initiation of triple therapy in this study were similar to those for dual therapy before 2011. Although race, marital status, and insurance were previously reported to be important, these associations were not observed by Chen et al.
The authors propose that the disappointingly low use of the new therapies, even after a decade without novel medications, could result from the continued requirement for interferon, the safety profile of the new drugs, low predicted rates of response for patients that did not respond to previous therapy, and hopes that interferon-free regimens could be around the corner.
Expanding HCV screening to people born between 1945 and 1965—the age group in whom up to 75% of HCV-related deaths occur—could increase the number of treatment-naive patients seeking HCV therapy.
Read the article online.
Chen EY, Sclair SN, Czul F, et al. A small percentage of patients with hepatitis c receive triple therapy with boceprevir or telaprevir. Clin Gastroenterol Hepatol 2013;11:1014-1020.e2.