Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C
Journal of Gastroenterology, 07/17/2012
Minami T et al. – The mortality rate during Pegylated interferon (PEG–IFN)/ribavirin (RBV) therapy was acceptably low, but the rate of serious adverse events (SAEs) was not negligible in a treatment for a benign disease, and the rate was affected by treatment regimens.Methods
- A literature search was conducted using MEDLINE, EMBASE, and the Cochrane Library to identify randomized controlled trials evaluating the efficacy and safety of PEG–IFN/RBV therapy.
- The authors calculated the crude mortality and SAE rates with 95 % confidence intervals (CIs).
- Eighty studies with 153 treatment arms that included 27569 patients were enrolled (14401 patients treated with Peg–IFN alpha–2a/RBV and 13168 with Peg–IFN alpha–2b/RBV).
- All–cause and treatment–related deaths were observed in 50 (0.18 %; 95 % confidence interval [CI] 0.13–0.24 %) and sixteen (0.058 %; 95 % CI 0.033–0.094 %) patients, respectively.
- The crude SAE rate was 7.08 % (95 % CI 6.75–7.41 %).
- Subgroup analysis revealed higher SAE rates in patients receiving PEG–IFN alpha–2a than in those with PEG–IFN alpha–2b (7.45 vs. 6.74 %), and higher SAE rates with higher doses than with the lower doses in PEG–IFN–2a and 2b (11.94 vs. 6.99 %, 7.10 vs. 5.05 %, respectively), and with extended duration (>48 weeks) than with standard duration (48 weeks) (15.5 vs. 6.67 %) in PEG–IFN alpha–2a.