Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901

作者：Manns Michael P^*; Akarca Ulus S; Chang Ting Tsung; Sievert William; Yoon Seung Kew; Tsai Naoky; Min Albert; Pangerl Andreas; Beebe Suzanne; Yu Miao; Wongcharatrawee Suchat

来源：Expert Opinion on Drug Safety, 2012, 11(3): 361-368.

DOI：10.1517/14740338.2012.653340

• chronic hepatitis B
• entecavir
• long-term
• nucleos(t)ide
• safety
• therapy

Objective: To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. %26lt;br%26gt;Methods: The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monotherapy in previous entecavir Phase II/III studies. Longterm cumulative safety results are based on reported AEs, regardless of causal relationship. %26lt;br%26gt;Results: Median exposure to entecavir in study ETV-901 was 184 weeks. Commonly reported AEs (%26gt;= 10%) were upper respiratory tract infection, headache and nasopharyngitis. Most AEs were mild to moderate; 203 (19%) patients reported grade 3 - 4 AEs, with 45 (4%) considered related to entecavir. There were 14 (1%) discontinuations due to AEs. On-treatment alanine aminotransferase (ALT) flares were reported in 32 (3%) patients and were associated with a reduction in hepatitis B virus DNA of more than 2 log(10) copies/ml in 25/32 patients. AEs potentially associated with nucleos(t) ide analogs were infrequent, the most common being myalgia (n = 54; 5%) and neuropathy-related AEs (hypoparesthesia and hyperparesthesia, polyneuropathy; n = 42; 4%). %26lt;br%26gt;Conclusions: Long-term administration of entecavir was associated with low rates of serious AEs, discontinuations due to AEs and ALT flares. AEs potentially associated with nucleos(t) ide use occurred at low rates.

• 出版日期2012-5