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HIV and Coverage of the
46th Annual Meeting of the European
Association for the Study of the Liver

March 30 - April 3, 2011, Berlin, Germany

Boceprevir Helps Hepatitis C Patients with Cirrhosis

SUMMARY: Chronic hepatitis C patients with advanced liver fibrosis or cirrhosis were more likely to achieve a cure when they added boceprevir to standard therapy, according to a report this week at EASL 2011.

By Liz Highleyman

Direct-acting hepatitis C virus (HCV) drugs -- the first of which are expected to be approved in the U.S. as soon as this summer -- will offer new hope to people with chronic hepatitis C. This is especially true for "hard-to-treat" patients including those with HCV genotype 1, prior non-responders, people of African descent, and individuals with advanced liver disease.

This week at the European Association for the Study of the Liver's International Liver Congress (EASL 2011) in Berlin, researchers presented an analysis of patient subgroups with advanced fibrosis or cirrhosis in 2 Phase 3 clinical trials of Merck's experimental protease inhibitor boceprevir (now known as Victrelis).

As reported in the March 31, 2011, New England Journal of Medicine, SPRINT-2 enrolled more than 1000 treatment-naive patients and RESPOND-2 included about 400 prior non-responders and relapsers.

Participants used pegylated interferon alfa-2b (PegIntron) plus ribavirin for a 4-week lead-in period, and were randomly assigned to subsequently either stay on standard therapy alone or add boceprevir, for either a fixed duration or using response-guided therapy.

Overall, both SPRINT-2 and RESPOND-2 showed that adding boceprevir led to significantly higher sustained virological response (SVR) rates compared with standard therapy alone.

The present sub-analysis looked at 100 previously untreated SPRINT-2 participants and 78 treatment-experienced RESPOND-2 participants who had advanced liver disease graded as Metavir fibrosis stage F3-F4.


Here too, sustained response occurred significantly more often in the boceprevir triple-therapy arms compared with the standard therapy control arms.
In SPRINT-2, SVR rates were 52% using fixed-duration boceprevir, 41% using boceprevir response-guided therapy, and 38% using standard therapy.
Among previously treated patients in RESPOND-2 the differences were greater: 68%, 44%, and 13%, respectively.
Boceprevir produced better outcomes among people with either good or poor initial response at week 4, and those who had either detectable or undetectable HCV RNA at week 8.

Based on these findings, the researchers concluded, "In treatment-naive or previous-treatment-failure patients with HCV [genotype] 1 infection and advanced fibrosis/cirrhosis, addition of boceprevir to [standard of care] in 48-week treatment arms was associated with enhanced SVR."

"SVR was also substantially increased in previous treatment failure patients using response-guided therapy," they continued, "and it was also achievable in patients poorly responsive to [interferon]."

Investigator affiliations: A.O. Fatebenefratelli e Oftalmico, Milan, Italy; Baylor College of Medicine, Houston, TX; Vall d'Hebron Hospital, Barcelona, Spain; Kaiser Permanente, San Diego, CA; Hospital Provincial del Centenario, Rosario, Argentina; Merck, Whitehouse Station, NJ.


S Bruno, JM Vierling, R Esteban, et al. Boceprevir in addition to standard of care enhanced SVR in hepatitis C virus (HCV) genotype-1 with advanced fibrosis/cirrhosis: subgroup analysis of S-2 and RESPOND-2 studies. 46th Annual Meeting of the European Association for the Study of the Liver (EASL 2011). Berlin. March 30-April 3. Abstract 195.
























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