At
the recent ICAAC, Spanish researchers presented the
latest data from the PRESCO trial treating coinfected individuals with pegylated
interferon plus weight-based ribavirin, which appears to help prevent HCV
relapse after the completion of therapy.
This
multicenter, prospective trial included 389 coinfected individuals with a median
age of 40 years; 49% had genotype
1 HCV, 39% had genotype
2 or 3, and 12% had genotype
4. About three-quarters were on HAART,
and the median baseline CD4 cell count
was 546 cells/mm3.
Patients
were treated with 180 mcg/week pegylated
interferon alpha-2a (Pegasys) plus 1000-1200 mg/day ribavirin. Those who experienced
early virological response (more than a 2 log drop in HCV RNA after 12 weeks of
therapy) continued on treatment for 48 or 72 weeks if they had genotype 1 or 4,
or 24 or 48 weeks if they had genotype 2 or 3. (Standard treatment duration is
48 weeks for genotypes 1/4 and 24 weeks for genotypes 2/3.)
Results
92 patients (45 with genotypes 1/4 and 54 with genotypes 2/3) received a prolonged
course of therapy.
66 patients (17%) interrupted anti-HCV therapy within the first 24 weeks due to
lack of virological response.
Another 108 subjects (28%) discontinued due to side effects or voluntary withdrawal,
mostly in the prolonged treatment arms.
In an intent-to-treat analysis, end-of-treatment response was seen in 262 total
participants (67%):
- 106 (55%) with genotype 1; - 137 (90%) with genotype
2 or 3; - 19 (41%) with genotype 4.
Sustained virological response (SVR) was seen in 190 total patients (49%):
-
68 (36%) with genotype 1; - 107 (70%) with genotype 2 or 3; - 15 (33%)
with genotype 4.
In a multivariate analysis, having genotype 2 or 3 HCV (OR 4.41; P < 0.0001)
and baseline HCV RNA below 500,000 IU/mL (OR 2.06; P = 0.002) were independent
predictors of SVR.
Prolonged treatment (72 weeks for genotypes 1/4 or 48 weeks for genotypes 2/3)
was not associated with greater higher likelihood of achieving sustained response.
Conclusion
"The
use of ribavirin 1000-1200 mg/day along with pegylated interferon alpha-2a provides
higher SVR than previously reported in HCV-HIV coinfected patients treated with
fixed low ribavirin dose," the researchers concluded. "In this study,
extension of treatment did not improve the efficacy of therapy."
The
SVR rates of 36% for genotype 1 and 70% for genotypes 2/3 in this study compare
favorably with those observed in the pivotal
APRICOT trial: 29% and 62%, respectively.
Hosp.
Carlos III, Madrid, Spain; Hosp. Xeral-Cies, Vigo, Spain; Hosp. San Jorge, Huesca,
Spain; Hosp. Clinico, Santiago, Spain; Hosp. de Cruces, Bilbao, Spain; Hosp. Clinico,
Valencia, Spain.
10/13/06
References M
Nunez, C Miralles, M A Berdun, and others. The PRESCO Study: Role of Extended
Therapy and/or Optimal Doses of Ribavirin in the Treatment of Chronic Hepatitis
C in HIV-Infected Patients. 46th ICAAC. San Francisco, CA. September 27-30, 2006.
Abstract V-1910.
92 patients (45 with genotypes 1/4 and 54 with genotypes 2/3) received a prolonged
course of therapy.