Journal Article

Retreatment of hepatitis C patients with pegylated interferon combined with ribavirin in non-responders to interferon plus ribavirin. Is it different in real life?

Tozzo, Raquel, Gonçales, Eduardo SL, Gonçales, Fernando L, Moma, Camila A, Gonçales, Neiva SL, Angerami, Adriana FCF, Vigani, Aline G, Pavan, Maria HP

2010

Overview

Background More than 50% of hepatitis C viruses (HCV)-infected patients do not respond to the classical Interferon (IFN)/Ribavirin (RBV) combination therapy. The aim of this study was to evaluate the efficacy of retreatment with Peg-Interferon alpha-2b (PEG-IFN alpha-2b) plus RBV, in patients with HCV, genotypes 1 or 3, who were non-responders to the previous standard treatment with IFN/RBV. Methods In the period 2005-2007, a total of 238 HCV chronic patients were non-responders to previous treatment with IFN plus RBV. Of these 130 agreed to be retreated with PEG-IFN alpha-2b and participated in this evaluation (90 with genotype 1 HCV and 40 with genotype 3 HCV). Patients were retreated at assisted IFN application hubs in compliance with the country's public health system rules. They received subcutaneous PEG-IFN alpha-2b, 1.5 μg, once weekly, associated with RBV, through the oral route, with doses determined according to weight (1,000 mg if weight ≤ 75 kg and 1,250 mg if > 75 kg). Patients with genotype 1 HCV were retreated for over 48 weeks and patients with genotype 3 HCV for over 24 weeks. HCV-RNA was tested by polymerase chain reaction (PCR) at baseline, at week 12, at the end of the treatment, and 6 months thereafter. The predictiveness of week 12 in the development of a sustained virologic response (SVR) was also evaluated. Patients with negative HCV-RNA at week 12 were considered as early virologic responders (EVR). Results EVR was observed in 25% of the patients with genotype 1 HCV and in 64% of the patients genotype 3 HCV (risk = 2.075 and p-value = 0.0414). SVR was observed in 22.2% of the patients with genotype 1 HCV and in 40% with genotype 3 HCV (intention-to-treat analysis). The positive predictive value (PPV) of the HCV-RNA testing at week 12, in order to obtain the SVR, was 65% for genotype 1 and 56% for genotype 3, and the negative predictive value (NPV) was 88% for genotype 1 and 89% for genotype 3. Conclusions PEG-IFN alpha-2b plus weight-based ribavirin is effective in re-treating previous interferon-α plus RBV failure; 22.2% of the patients with genotype 1 HCV and 40% of patients with genotype 3 HCV achieved SVR.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Antiviral agents / Antiviral Agents - administration & dosage / Demographic aspects / Dosage and administration / Drug therapy / Drug therapy, Combination / Drug Therapy, Combination - methods / Female / Genotype / Health aspects / Hepacivirus - classification / Hepacivirus - genetics / Hepacivirus - isolation & purification / Hepatitis C / Hepatitis C virus / Hepatitis C, Chronic - drug therapy / Humans / Infectious Diseases / Interferon-alpha - administration & dosage / Interferons - administration & dosage / Internal Medicine / Male / Medical Microbiology / Medicine / Medicine & Public Health / Middle Aged / Parasitology / Patient outcomes / Polyethylene Glycols - administration & dosage / Recombinant Proteins / Research Article / Retreatment - methods / Ribavirin - administration & dosage / RNA, Viral - blood / Treatment Outcome / Tropical Medicine / Viral Load