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Therapy with Reduced Dose of Pegylated Interferon Plus Ribavirin in HCV & HIV Coinfected Patients
  Editorial note from Jules Levin: This study examines giving a reduced dose of PegIntron with a fixed dose of 800 mg of ribavirin to coinfected patients. Interferon and ribavirin may be difficult to tolerate and have toxicity for some HIV infected patients as studies in coinfected patients often have greater discontinuation rates. Therefore, this study is important in that it examines providing a reduced dose of peginterferon plus only 800 mg of ribavirin. The results are interesting and significant for real world clinic settings. The study results suggest you can start therapy with full dose of peginterferon and if after a few months the patient wants to discontinue therapy due to the side effects you can reduce the interferon and ribavirin doses and still see a reasonable viral response to therapy.
Therapy of chronic hepatitis C (CHC) in HIV-infected patients has become a major issue over the last few years since an increasing number of HCV-HIV coinfected individuals are prone to develop cirrhosis and end-stage liver disease. Moreover, more successful treatment for chronic hepatitis C (CHC) is not available.
Preliminary data suggest that sustained response (SR) can be achieved in more than 50% of HIV-negative patients with CHC using Pegylated interferon (PEG-IFN) plus ribavirin (RBV). We analyzed the efficacy and safety of PEG-IFN plus RBV in coinfected patients.
Sixty-nine subjects (70% males, mean age 37 yr) naive for IFN plus RBV were enrolled in the trial. All had CD4 counts > 300 cell/mm3, plasma HIV RNA < 5000 cop/ml and 95% were receiving antiretroviral therapy.
PEG-IFN alfa-2b 150 mcg sc (PegIntron) once weekly plus RBV 800 mg daily were given during the first 3 months. The dose of PEG-IFN was then reduced to 100 mcg/week until completion of 6 (HCV 2/3) or 12 months (HCV 1/4) of therapy. At baseline HCV-RNA > 800,000 UI/ml was seen in 53%. Genotype distribution was: HCV 1/4:62% and HCV-3: 38%.
End-of-treatment response (ETR) was achieved in 49% of patients (31% of HCV 1/4 and 88% of those with HCV-3). The preliminary data suggest that SR was reached in 73% of patients with ETR. Discontinuation due to adverse events ocurred in 7% of patients.
One patient receving ddI developed acute pancreatitis and weight loss more than 10% was recorded in 70% of patients. RBV doses needed to be reduced in 4% of subjects. No increases in plasma HIV-RNA were seen.
The authors concluded that the combination of PEG-IFN plus RBV is relatively well tolerated and provides SR in nearly 40% of coinfected patients. This rate of SR seems to be lower than observed in HIV-negative subjects.
Miriam Romero et al, Madrid, Spain, AASLD November 2002. Abstract 801.
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