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.
Results
 |
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.
4/1/11
Reference
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.
