This article is more than 5 years old. Information may no longer be current.

Telaprevir, Boceprevir not Toxic in Real-World Study

Regimens containing telaprevir and boceprevir demonstrated improved 12-week sustained virologic response rates with lower toxicity compared with those containing pegylated interferon and ribavirin, according to results of a large analysis.

“SVR rates are higher and closer to those reported in pivotal clinical trials among [boceprevir]- and [telaprevir]-treated persons compared with [pegylated interferon/ribavirin]-treated persons,” Adeel A. Butt, MD, MS, FIDSA, of the University of Pittsburgh School of Medicine, and colleagues wrote. “Hematologic adverse events are frequent, but severe toxicity is uncommon.”

Adeel A. Butt

The researchers aimed to evaluate real-world SVR12 and hematologic adverse event rates associated with regimens containing boceprevir (Victrelis, Schering-Plough) and telaprevir (Incivek, Vertex Pharmaceuticals) compared with those reported for regimens containing peginterferon and ribavirin. Data were culled from the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES). Patients in the peginterferon/ribavirin group served as controls and had genotype 1 disease.

The analysis included 2,288 patients receiving boceprevir, 409 treated with telaprevir and 6,308 treated with peginterferon and ribavirin. Thirty-one percent of patients in the boceprevir arm had treatment experience vs. 43% in the telaprevir arm and 9% in the peginterferon/ribavirin arm. Cirrhosis at baseline was reported in 17% of the boceprevir group, 37% in the telaprevir group and 14% of the peginterferon/ribavirin group. The proportion of genotype 1a disease was 63% for boceprevir, 54% for telaprevir and 48% for peginterferon/ribavirin.

The main exclusion criteria included HIV coinfection and missing HCV RNA data.

Apart from SVR12, hematologic toxicity — defined as grade 3/4 anemia, neutropenia and thrombocytopenia — served as the primary outcome measures.

SVR12 rates for noncirrhotic, treatment-naive patients were 65% for boceprevir, 67% for telaprevir and 31% for peginterferon/ribavirin. In the treatment-experience, noncirrhotic group, SVR12 was 57% for boceprevir, 54% for telaprevir and 13% for peginterferon/ribavirin. There was no significant difference for the comparison of boceprevir and telaprevir. However, there was a significant difference between boceprevir and telaprevir vs. peginterferon/ribavirin (P<.0001).

Grade 3/4 anemia occurred in 7% of the boceprevir group, 11% of the telaprevir group and 3% of those receiving peginterferon/ribavirin. The rates for grade 4 thrombocytopenia were 2.2%, 5.4% and 1.7%, respectively, while grade 4 neutropenia occurred in 8.2% of patients receiving boceprevir, 5.6% of those receiving telaprevir and 3.4% of those receiving peginterferon/ribavirin.

Disclosure: The researchers report various financial associations with AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Gilead, Janssen, MedImmune, Merck, Synteract and Vertex.

Editor's Note: Both telaprevir and boceprevir have recently been pulled from the market.