July 26, 2013

Futility, discontinuation of HCV therapy more common in practice than clinical trials

Provided by Healio

Belperio PS. Clin Gastroenterol Hepatol. 2013;11:1021-1027.

July 26, 2013

Patients with hepatitis C treated with direct-acting antivirals in routine practice were more likely to experience early discontinuation or futility than those treated in clinical trials in a recent study.

Researchers evaluated data from veterans with chronic HCV genotype 1 treated with pegylated interferon and ribavirin with either boceprevir (n=661) or telaprevir (n=198) before January 2012. Patient data was collected from the Veterans Affairs’ Clinical Case Registry. HCV RNA levels were measured at 4, 8, 12 and 24 weeks of treatment.

Among treatment-naive, noncirrhotic participants, more patients in the boceprevir group had undetectable HCV RNA levels at 24 weeks (74% of cases vs. 60% of telaprevir recipients; P=.03). Early response occurred at similar rates among prior null or partial responders, relapsers and cirrhotic patients, though undetectable RNA at 24 weeks was more common among treatment-naive patients in the boceprevir group (71% vs. 58%; P=.02).

At 24 weeks, treatment discontinuation and futility had occurred in 30% and 14%, respectively, of the boceprevir group and 34% and 17%, respectively, of the telaprevir group. Multivariate analysis indicated that prior null response (OR=2.98; 95% CI, 1.73-5.13) and diabetes (OR=1.49; 95% CI, 1.01-2.21) were predictive of treatment failure among boceprevir recipients. In the telaprevir group, diabetes was predictive of failure (OR=2.15; 95% CI, 1.11-4.17) and prior relapse was associated with reduced failure risk (OR=0.18; 95% CI, 0.06-0.57).

“In routine medical practice, treatment with boceprevir- or telaprevir-based antiviral therapy had better early results than previously observed with pegylated interferon/ribavirin alone, but results [were] not quite as good as seen in the clinical trials,” researcher Lisa I. Backus, MD, PhD, national clinical manager of clinical case registries for the Office of Public Health/Population Health in Palo Alto, Calif., told Healio.com. “In particular, in routine medical practice, more patients discontinue treatment early than in clinical trials.” She said the lower early response rates observed among prior null responders suggest a need for patients and providers to make very considered treatment decisions.

Disclosure: The researchers report no relevant financial disclosures.


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