Boceprevir Helps Hepatitis C Patients with Cirrhosis EASL
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
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
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.