Positive
Impact of Higher Ribavirin Doses and Longer Duration of Therapy with Pegasys plus
Ribavirin in HIV/HCV Coinfected Patients: The PRESCO Trial
The
fact that HIV-HCV coinfected individuals experience faster progression to end-stage
liver disease has made the treatment of chronic HCV infection in HIV positive
patients a high priority. Prior studies have reported that coinfected patients
experience a poorer response compared to HCV-monoinfected individuals.
In
PRESCO,
a prospective, multicenter, open, comparative trial, HCV/HIV-coinfected patients
with elevated ALT who had not previously been exposed to interferon were treated
with pegylated
interferon alfa-2a (Pegasys) 180 mcg per week) plus ribavirin (1,000 mg daily
if body weight <75 Kg; 1,200 mg daily if >75 kg).
Patients with
HCV genotypes 1 and 4 (61%) were treated for 48 or 72 weeks, while patients with
HCV genotypes 2 and 3 (39%) were treated for 24 or 48 weeks. Patients without
early virological response discontinued therapy at 12-24 weeks.
Results
Out of 389 patients included in the trial, 137(61%) were infected by HCV-1/4 and
67% had high HCV RNA levels.
Treatment was prematurely discontinued in 46%, due to: virologic failure 17%,
serious adverse events 7%, voluntary withdrawal or lost-to-follow-up 22%.
In an intent-to-treat analysis, sustained virological response (SVR) was achieved
in 49.1% patients, significantly more frequently in patients infected with HCV-2/3
(71%) than 1/4 (35%) (p<0.0001).
No significant differences in SVR were observed when comparing short and extended
treatment arms.
Relapses according to length of therapy and HCV genotype are displayed in the
table. Infection with HCV-2/3, lower baseline HCV-RNA, and negative serum HCV
RNA at week 12 were independent predictors of SVR in the multivariate analysis.
In
conclusion, the authors, write, "Nearly half of HIV/HCV-coinfected patients
treated with RBV 1,000-1,200 mg/daily plus pegylated interferon alfa-2a [Pegasys]
180 mcg per week achieved SVR."
"Response was twice higher in
HCV-2/3 than HCV-1/4 carriers."
"The use of higher doses of
ribavirin rather than extended duration of therapy seems to account for the good
results obtained in this study."
Table:
Relapses according to Length of Therapy and HCV Genotype
Treatment
HCV-1/4
HCV-2/3
All*
Short
35/108
(25.9%)
14/81
(17.3%)
49/189
(26%)
Extended
3/9
(33.3%)
7/45
(15.5%)
10/54
(16.9%)
All**
38/117
(32.4%)
21/126
(16.7%)
59/243
(24.8%)
*p=0.2
for all short vs extended treatment arms **p=0.01 for all HCV-1/4 vs HCV-2/3
Hospital Carlos
III, Madrid, Spain.
11/03/06
Reference M
Nunez, J Garcia-Samaniego, M Romero, and others. The PRESCO trial: impact of higher
ribavirin doses and longer duration of therapy with peginterferon alfa-2a plus
ribavirin in HIV-infected patients with chronic hepatitis C. 57th AASLD. October
27-31, 2006. Boston, MA. Abstract 365.
Out of 389 patients included in the trial, 137(61%) were infected by HCV-1/4 and
67% had high HCV RNA levels. 
