RESUMO
BACKGROUND/AIMS: Thymalfasin has shown efficacy in the treatment of chronic HCV infection. The aim of this study was to evaluate the efficacy and tolerability of triple therapy with thymalfasin, peginterferon alpha-2a (PEG-IFN alpha-2a), and ribavirin in Hispanic patients with chronic viral hepatitis C who were nonresponders to prior treatment with interferon alfa (IFN-alpha)/ribavirin. METHODS: In this open-label study, 40 subjects received thymalfasin (1.6 mg twice a week), PEG-IFN alpha-2a (180 microg once a week), and ribavirin (800-1,000 mg/day) for 48 weeks. All patients had positive HCV RNA by PCR analysis, abnormal levels of ALT, compensated hepatic disease, and liver biopsy with chronic damage. RESULTS: Viral response was observed in 52.5% patients at week 12 and 50% at week 24. Of the per protocol group, 52.6% showed an end-of-treatment response at week 48 and 21.1% achieved an SVR at week 72. Among genotype 1 patients, 23.5% achieved an SVR at week 72. A reduction of the dose of PEG IFN alpha-2a and ribavirin was required. Thymalfasin was well tolerated without dose reduction. CONCLUSION: Triple therapy with thymalfasin, PEG IFN alpha-2a, and ribavirin is an effective treatment option for difficult-to-treat HCV patients who are refractory to prior conventional treatment, with adequate tolerability.
Assuntos
Adjuvantes Imunológicos/administração & dosagem , Antivirais/administração & dosagem , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , Interferon-alfa/administração & dosagem , Polietilenoglicóis/administração & dosagem , Ribavirina/administração & dosagem , Timosina/análogos & derivados , Adjuvantes Imunológicos/efeitos adversos , Adulto , Idoso , Antivirais/efeitos adversos , Feminino , Hepacivirus/genética , Humanos , Interferon alfa-2 , Interferon-alfa/efeitos adversos , Masculino , México , Pessoa de Meia-Idade , Projetos Piloto , Polietilenoglicóis/efeitos adversos , RNA Viral/análise , Proteínas Recombinantes , Ribavirina/efeitos adversos , Terapia de Salvação , Timalfasina , Timosina/administração & dosagem , Timosina/efeitos adversos , Resultado do Tratamento , Adulto JovemRESUMO
AIDS: Thymosin-Alpha-1 (Zadaxin) is a synthetic hormone that has been studied as a treatment for HIV, hepatitis B, and hepatitis C. Recently approved in Mexico as a booster for the flu vaccine, it was also approved in nine other countries for flu, hepatitis B, and hepatitis C. The demand for Thymosin is great but it is difficult to procure. A partnership between Schering-Plough and SciClone Pharmaceuticals has renewed hope that the demand for Thymosin will be met. Schering-Plough is also marketing Rebetron, a packaged combination of Ribavirin capsules and injectable alpha-interferon (Intron-A), for the treatment of hepatitis C. Other hepatitis treatments are described, such as Epivir-HBV (3TC, Epivir) which was approved in December for the treatment of Hepatitis B. Epivir-HBV has shown promising results.^ieng