Efficacy of triple therapy with thymalfasin, peginterferon alpha-2a, and ribavirin for the treatment of hispanic chronic HCV nonresponders.

Abstract

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.

• Authors: Jorge L Poo, Francisco Sánchez Avila, David Kershenobich, Xochitl García Samper, Rocío Torress-Ibarra, Julieta Góngora, Carlos Cano, Miguel Parada, Misael Uribe
• Journal: Annals of hepatology (Ann Hepatol) 2008 Oct-Dec Vol. 7 Issue 4 Pg. 369-75 ISSN: 1665-2681 [Print] Mexico
• PMID: 19034238 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Adjuvants, Immunologic
• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• Thymosin
• peginterferon alfa-2a
• Thymalfasin

Topics

• Adjuvants, Immunologic (administration & dosage, adverse effects)
• Adult
• Aged
• Antiviral Agents (administration & dosage, adverse effects)
• Female
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, adverse effects)
• Male
• Mexico
• Middle Aged
• Pilot Projects
• Polyethylene Glycols (administration & dosage, adverse effects)
• RNA, Viral (analysis)
• Recombinant Proteins
• Ribavirin (administration & dosage, adverse effects)
• Salvage Therapy
• Thymalfasin
• Thymosin (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome
• Young Adult