Chronic viral hepatitis B and C are a significant cause of chronic liver disease worldwide and still represent a pathology difficult to treat.
Drugs available for the treatment of chronic hepatitis B (CHB) include nucleoside analogues, nucleotide analogues and immunomodulatory agent. Lamivudine is the most commonly prescribed drug in CHB worldwide, but resistance to lamivudine occurs in 15-30% of patients during the first year of treatment.
Telbivudine (an HBV specific L-nucleosid analogue of thymidine) has a greater antiviral suppression than lamivudine in phase II and III clinical trials. The GLOBE trial (1) demonstrated a higher efficacy for telbivudine and similar safety to lamivudine in HBeAg-positive and HBeAg-negative patients (over 1369 patients). Telbivudine was associated with fewer flares of serum ALT levels when compared to lamivudine and showed significantly less primary and secondary failure, breakthrough and resistance. A recent study (2) compared the antiviral efficacy and safety of telbivudine switch (600 mg/ day) vs. continued lamivudine treatment in patients with persistent viraemia after previous lamivudine treatment. Early switch (before 24 weeks of lamivudine treatment) to telbivudine may improve the patient's outcomes; switching lamivudine-resistant patients to telbivudine monotherapy may have a limited role, and to achieve a more potent antiviral effect and prevent multidrug resistance; the combination of telbivudine with another nucleotide could be another option.
Recently, US Food and Drug Administration approved boceprevir (Victrelis®) for the treatment of chronic hepatitis C; it's the first new drug in the last 20 years. Boceprevir is an NS3/4A serine protease inhibitor. In combination with peginteferon alfa and ribavirin, boceprevir is approved for adults patients with chronic hepatitis C or compensated cirrhosis, who are untreated or in whom previous failed after bitherapy. Recommended dose is 800 mg/ day, administrated orally 3 times a day (3). The approval was based on data from 3 randomized trials reported in March 2011 in NEJM. The most commonly adverse effects were anemia, neutropenia, fatigue, and headache. The drug is expected to be found in pharmacies in US in June 2011. We are waiting for approval of this drug in Europe.
References
- 1.Liaw YF, Gane E, Leung N, et al. 2-year GLOBE trial results: telbivudine is superior to lamivudine in patients with chronic hepatitis B. Gastroenterology. 2009;136:486–495. doi: 10.1053/j.gastro.2008.10.026. [DOI] [PubMed] [Google Scholar]
- 2.Rifaat Safadi, Qing Xie, Yagang Chen, et al. Efficacy of Switching to Telbivudine in Chronic Hepatitis B Patients Treated Previously with Lamivudine. Liver International. 2011;31:667–675. doi: 10.1111/j.1478-3231.2010.02360.x. [DOI] [PubMed] [Google Scholar]
- 3.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm