Estudio clínico abierto, no controlado para la evaluación de la seguridad y eficacia del interferón alfa 2b pegilado PEG-Heberon® más ribavirina para el tratamiento de la infección crónica por el virus de la hepatitis C en pacientes cubanos

The pegylated forms of recombinant human interferon-alpha 2 have substantially improved the sustained virologic response (SVR) and are in the current guidelines for the treatment of chronic hepatitis due to the hepatitis C virus (HCV), but their high costs limit their availability. The aim of this study was to evaluate the efficacy and safety of PEGHeberon® (40-kDa pegylated interferon alpha-2b), a formulation developed by the Center for Genetic Engineering and Biotechnology. An open, uncontrolled clinical trial was conducted at the National Gastroenterology Institute of Havana, in 147 patients that were chronically infected with the hepatitis C virus; 55 % were females of 50.1 ± 10.8 years of age, 94.6 % were of genotype 1 with high viral loads, and 54.4 % were mostly non-responders to previous treatments. Response-guided therapy was applied according to the genotype and viral load with Peg-Heberon® and ribavirin. Viral serum titers of the hepatitis C virus were used to evaluate the response to treatment. The intention to treat statistical analysis was carried out and logistic regression analyses were performed to identify independent predictors of SVR. A 46.3% of naive patients attained SVR versus 21.3 % in non-responders to previous treatments. The rapid virological response achieved on the fourth week of the treatment was the main independent predictor of SVR. A total of 98 % of 920 adverse events were mild to moderate, while systemic adverse events were more frequent (68.4 %). Hematological alterations were found in 26.8 % of the patients. PEG-Heberon® is safe, well tolerated and effective, and therefore, a good option for the treatment of HCV chronically-infected patients.