Pegasys Versus PegIntron for Combination Hepatitis C Treatment of HIV-HCV Coinfected
Patients Pegylated
interferon plus ribavirin is the current standard of care for chronic hepatitis
C virus (HCV) infection. Two brands of pegylated interferon are currently approved
for this indication: pegylated
interferon alfa-2a (Roche's Pegasys) and pegylated
interferon alfa-2b (Schering-Plough's PegIntron). At
the 47th Interscience Conference on Antimicrobial Agents
and Chemotherapy this week in Chicago, researchers with the Spanish GESIDA
Clinical Trials Agency reported the results of a study comparing the safety and
efficacy of Pegasys and PegInton, both in combination with ribavirin, in HIV-HCV
coinfected patients. The
researchers conducted an analysis of participants in the GESIDA Cohort study,
which prospectively follows HIV-HCV coinfected patients who started anti-HCV therapy
between Jan 2000 and December 2005 at 11 institutions in Spain. The study included
previously treatment-naive patients who started combination therapy with either
Pegasys (n = 315) or PegIntron (n = 242) plus ribavirin. The
only significant difference in baseline characteristics was a lower proportion
of patients with advanced fibrosis (stage F3-F4) in the Pegasys arm compared with
the PegIntron arm (32.8% vs 42.0%). No differences were found with regard to ribavirin
dose or duration of anti-HCV therapy. The
primary efficacy endpoint was a sustained virological response (SVR), defined
as undetectable serum HCV RNA 24 weeks after the completion of anti-HCV therapy.
Results
Factors
independently associated with SVR by logistic regression analysis were CDC clinical
HIV disease category and HCV genotype.
Genotypes
1 or 4 were associated with a lower SVR rate than genotypes 2 or 3.
Efficacy
and safety results are summarized in the table below:
| |
Pegasys |
PegIntron |
|
N=315 |
N=242 |
| Efficacy
(SVR by ITT) |
|
|
| All
patients |
103/315 (32.7%) |
76/242 (31.4%) |
| HCV
genotypes 1 or 4 |
37/193 (19.2%) |
21/146 (14.4%) |
| HCV
genotypes 2 or 3 |
48/107 (44.9%) |
39/85 (45.9%) |
| Safety |
|
|
| Interruption
of anti-HCV treatment due
to adverse events |
47 (14.9%) |
33 (13.6%) |
| Deaths |
2 (0.6%) |
4 (1.7%) |
|
Hepatic
decompensation |
7 (2.2%) |
4 (1.7%) |
Conclusion Based
on these findings, the investigators concluded, "No differences were found
in efficacy/safety between [Pegasys] and [PegIntron] for the treatment of chronic
HCV infection in HIV-infected patients." 09/21//07 Reference
J Berenguer,
J Gonzalez, J Lopez Aldeguer, and others. Peginterferon Alfa-2a Plus Ribavirin
vs Peginterferon Alfa-2b Plus Ribavirin for Chronic Hepatitis C Virus Infection
in HIV-Infected Patients. 47th Interscience Conference on Antimicrobial Agents
and Chemotherapy. Chicago, September 17-20, 2007. Abstract V-1897.
|