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

• Published in: BMC infectious diseases Vol. 10; no. 1; p. 212
• Main Authors: Gonçales, Jr, Fernando L, Moma, Camila A, Vigani, Aline G, Angerami, Adriana F C F, Gonçales, Eduardo S L, Tozzo, Raquel, Pavan, Maria H P, Gonçales, Neiva S L
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20-07-2010; BioMed Central; BMC
• Subjects: 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; Interferon-alpha - administration & dosage; Interferons - administration & dosage; Male; Middle Aged; Patient outcomes; Polyethylene Glycols - administration & dosage; Recombinant Proteins; Retreatment - methods; Ribavirin - administration & dosage; RNA, Viral - blood; Treatment Outcome; Viral Load; Brazil
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/1471-2334-10-212

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.
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 microg, once weekly, associated with RBV, through the oral route, with doses determined according to weight (1,000 mg if weight <or= 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).
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.
PEG-IFN alpha-2b plus weight-based ribavirin is effective in re-treating previous interferon-alpha plus RBV failure; 22.2% of the patients with genotype 1 HCV and 40% of patients with genotype 3 HCV achieved SVR.