Efficacy of peginterferon alpha‐2b in chronic hepatitis delta: Relevance of quantitative RT‐PCR for follow‐up

Hepatitis delta virus (HDV) can cause severe acute and chronic liver disease in patients infected by hepatitis B virus. Interferon alpha at high doses, although poorly efficient, is the only treatment reported to provide some benefit in chronic hepatitis delta. Pegylated interferon alpha (PEG‐IFN) has not yet been evaluated. Treatment is usually monitored by the qualitative detection of HDV‐RNA in serum. In this study, safety and efficacy of PEG‐IFN were assessed in chronic hepatitis delta, and serum HDV‐RNA kinetics were determined using quantitative RT‐PCR. Fourteen patients with chronic hepatitis delta received subcutaneous PEG‐IFN alpha‐2b during 12 months (1.5 μg/kg per week). Serum HDV‐RNA was quantified at initiation and during the course of therapy, and during the posttreatment follow‐up period, which ranged from 6 to 42 months (median 16 months). PEG‐IFN alpha‐2b was well tolerated, inducing no serious adverse effect. Sustained biochemical response was obtained in 8 patients (57%). At the end of treatment, 8 patients (57%) had achieved virological response (undetectable HDV‐RNA). Sustained virological response throughout the posttreatment follow‐up period was observed in 6 patients (43%). HDV‐RNA kinetics were predictive of the response: after 3 months of PEG‐IFN, HDV‐RNA levels were significantly lower in the responders than in the nonresponders group (P = .018). After 6 months of therapy, a negative HDV‐RNA was predictive of sustained response (P = .021). In conclusion, this preliminary study indicates that PEG‐IFN alpha‐2b is safe and efficient for treatment of chronic hepatitis delta. The follow‐up of HDV‐RNA levels during therapy, which allows the differentiation of various profiles of virological responses, improves treatment monitoring. (HEPATOLOGY 2006;44:728–735.)