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PegIntron plus Ribavirin in 65 HCV/HIV Coinfected Patients
Reported by Jules Levin
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A Spanish research group (Romero, Soriano, et al) reported end-of -treatment
results from a study of 65 HIV/HCV coinfected patients in a poster at the
April 2002 EASL liver meeting in Madrid. The purpose of the study is to
examine the efficacy and safety of PegIntron and ribavirin in HIV+ patients
with chronic hep C.
The study looked at 65 HIV+ patients who never before received interferon
treatment. They had >300 CD4s and HIV viral load <5000 copies/ml. 95% were
on HAART and 55% had >800,000 IU/ml. 56% of the patients had genotype 1. In
the USA 70% have genotype 1. 30% in this study had genotype 3 and 14%
genotype 4. The patients all received a fixed weekly dose of PegIntron (150
mcg/week for 3 months and 100 mcg/week until complete 6 months in genotype
2/3 and 12 months in genoytype 1/4). Usually, PegIntron is prescribed to be
taken by weight. It is approved to be taken at 1.5 mcg/kg per week. There are
2.2 lbs per kg. Patients received a fixed dose of 800 mg of ribavirin per day. Often ribavirin is dosed by weight.
RESULTS
The average age of the patients was 37. The preliminary end of treatment
response reported was 63% for genotype 3 patients and 37% for genotype 1 and
4 combined. 22% of patients experienced a breakthrough. Breakthrough is when
you achieve undetectable viral load but it goes back up while on treatment.
The overall viral response at the end of treatment was 54%. No increases in
HIV viral load were reported.
Adverse events leading to discontinuation occurred in 14%. Most commonly
reported side effects were: flu-like symptoms, depression, asthenia
(fatigue), gastrointestinal disorders. Of note was weight loss (70% of
patients lost >10% of baseline weight).
The authors said the sustained response data will be available in the summer
2002. The amount of information reported was limited. The authors were not
clear how many patients were available for the ETR analysis. They did not
report if there were dose adjustment or modifications. The average HCV viral
load at baseline was not provided. And the adverse event profile reported was
limited.
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