Final analysis of the international observational S-Collate study of peginterferon alfa-2a in patients with chronic hepatitis B
PLOS ONE
Authors: Marcellin, Patrick; Xie, Qing; Paik, Seung Woon; Flisiak, Robert; Piratvisuth, Teerha; Petersen, Joerg; Asselah, Tarik; Cornberg, Markus; Ouzan, Denis; Foster, Graham R.; Papatheodoridis, Georgios; Messinger, Diethelm; Regep, Loredana; Bakalos, Georgios; Alshuth, Ulrich; Lampertico, Pietro; Wedemeyer, Heiner
Abstract
Background and aims Sustained off-treatment immune control is achievable in a proportion of patients with chronic hepatitis B treated with peginterferon alfa-2a. We evaluated on-treatment predictors of hepatitis B surface antigen (HBsAg) clearance 3 years after peginterferon alfa-2a treatment and determined the incidence of hepatocellular carcinoma. Methods A prospective, international, multicenter, observational study in patients with chronic hepatitis B who have been prescribed peginterferon alfa-2a (40KD) in a real-world setting. The primary endpoint was HBsAg clearance after 3 years' follow-up. Results The modified intention-to-treat population comprised 844 hepatitis B e antigen (HBeAg)positive patients (540 [64%] completed 3 years' follow-up), and 872 HBeAg-negative patients (614 [70%] completed 3 years' follow-up). At 3 years' follow-up, HBsAg clearance rates in HBeAg-positive and HBeAg-negative populations, respectively, were 2% (16/844) and 5% (41/872) in the modified intention-to-treat population and 5% [16/328] and 10% [41/394] in those with available data. In HBeAg-positive patients with data, Week 12 HBsAg levels < 1500, 1500-20,000, and > 20,000 IU/mL were associated with HBsAg clearance rates at 3 years' follow-up of 11%, 1%, and 5%, respectively (Week 24 predictability was similar). In HBeAg-negative patients with available data, a >= 10% decline vs a <10% decline in HBsAg at Week 12 was associated with HBsAg clearance rates of 16% vs 4%. Hepatocellular carcinoma incidence was lower than REACH-B (Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B) model predictions. Conclusions Sustained off-treatment immune control is achieved with peginterferon alfa-2a in a real-world setting. HBsAg clearance 3 years after completion of peginterferon alfa-2a can be predicted on the basis of on-treatment HBsAg kinetics.
Impact of long-term systemic treatment for psoriasis on liver disease in psoriasis patients with coexisting hepatitis B virus infection
DERMATOLOGIC THERAPY
Authors: Chularojanamontri, Leena; Nimanong, Supot; Wongpraparut, Chanisada; Silpa-Archa, Narumol; Chaiyabutr, Chayada; Charoenpipatsin, Norramon
Abstract
Continuously updated information is helpful for evaluating the safety of long-term systemic drug use in psoriasis patients with concomitant hepatitis B virus (HBV) infection. To investigate the impact of long-term systemic treatment for psoriasis on liver disease in psoriasis patients with HBV infection. Data of patients during 10-year period were recorded and analyzed. Sixty-six patients (46 males and 20 females) with a mean age of 58.5 +/- 13.1 years were recruited. Our study estimated that the 5-year cumulative risks of developing cirrhosis and HCC were 30% and 5%, respectively, in patients receiving systemic treatments for psoriasis. Risks of cirrhosis and HCC were not significantly different between systemic and topical treatment groups. Thirty patients were prescribed systemic treatments (acitretin, methotrexate, ciclosporin, and anti-tumor necrosis factors). Three HBsAg+ patients developed viral reactivation (two patients with methotrexate and one patient with ciclosporin). The effects of systemic treatments for psoriasis on liver outcome in patients with coexisting HBV infection are needed to be determined. HBsAg+ patients are more likely to develop viral reactivation during systemic treatment for psoriasis than HBsAg- patients. Monitoring of liver enzymes and HBV DNA every 3 months is recommended during treatment and for 6 to 12 months after drug discontinuation.