Safety and efficacy of pegylated interferon alfa-2a for the treatment of hepatitis c in patients with major thalassemia

Hepatitis C virus [HCV] infection is the most common transfusion transmitted disease in poly-transfused patients worldwide. In this study we aimed to evaluate the effects of pegylated interferon alfa-2a [PEG-IFN A-2a] in reducing serum ALT and eradicating serum hepatitis C virus [HCV] RNA in HCV infected polytransfused thalassemic patients. A cohort of 51 HCV-RNA positive thalassemic patients were enrolled to our study and received 180 u,g PEG-IFN A-2a once-weekly for 48 weeks. The primary end point was sustained virological response [SVR]. The secondary outcome was normalization of ALT. Patient safety was assured by monthly, and if needed, weekly laboratory assessment and visits. Of 52 patients, 42 participants completed the treatment schedule. A sustained virological response [SVR] was attained in 22/51 [43%] cases. Among non-responders or relapsers to previous HCV antiviral therapy, 9/27 [33%] attained an SVR. Five patients died during treatment and 3 subjects discontinued the therapy because of adverse effects. Adverse events were generally mild, and laboratory abnormalities were rare. A course of 48-week PEG-IFN A-2a monotherapy is effective in eradicating HCV-RNA during treatment. But about one third of thalassemic patients would relapse within 6 months of treatment schedule completion, in whom combination therapy is needed

Efficacy and safety of pegylated interferon fllfa-2a plus ribavirin for treatment of chronic hepatitis C and cirrhosis in Iranian

Background and aims: pegylation of Interferon prolongs the medication half-life, which has resulted in introducing Pegylated Interferon [PEG-IFN] as the new modality for treatment of chronic hepatitis C. This clinical trial was conducted to assess the efficacy and safety of Peg-INF in combination with ribavirin in a number of Iranian patients with chronic hepatitis C or cirrhosis

Methods: fifty-two patients with HCV RNA in serum, persistently elevated aminotransferase levels, and chronic hepatitis [n=45] or cirrhosis [n=7] on liver biopsy were enrolled to this study. The patients received PEG-IFN [40 kD] 180 micg per week plus ribavirin 10- 15 mg/kg per day. Treatment lasted 48 weeks and was followed by a 24-week follow up period to assess sustained virologic response [SVR]. The patients consisted of 46 males and 6 females with a mean age of 38.5 +/- 10.9 years

Results: in an intention-to-treat analysis HCV RNA was undetectable in 43 patients [83.7%] at week 48 and SVR was achieved in 28 patients [53.8%]. SVR was achieved in 62.9% of naïve patients, 35.3% of the patients who had a past failed treatment with IFN-based therapy, 60.0% of patients with chronic hepatitis and 14.3% of cirrhotic patients. In two patients [3.8%] adverse event led to treatment discontinuation and in eight patients [15.3%] dose modification of medication was required

Conclusion: this study showed that combination therapy with PEG-IFN plus ribavirin was associated with a promising SVR rate and acceptable tolerability in Iranian patients. This regimen may be effective for patients who failed prior IFN-based treatment