title: Hepatic safety profile of fosamprenavir-containing regimens in HIV-1-infected patients with or without hepatitis B or C coinfection.
abstract: OBJECTIVE
  This post hoc analysis investigated the hepatic safety profile of fosampre-navir (FPV) in patients monoinfected with HIV or coinfected with HIV and hepatitis B (HbsAg positive) and/or hepatitis C (anti-HCV antibody positive).
  
  
  METHODS
  Data were pooled from 7 prospective, randomized clinical trials of FPV.
  
  
  RESULTS
  Baseline demographics were generally well-matched between the 205 coinfected (72% HCV, 24% HBV, 3% both) and 1,114 monoinfected patients in this analysis. At baseline, most regimens included ritonavir 100 mg (58%) or 200 mg (38%), and 73% of subjects were ART-naïve. Over 48 weeks, the rate of treatment-related serious adverse events was similar between the coinfected (8%; 16/205) and monoinfected (6%; 62/1114) groups, and the rate of treatment-related grade 2-4 adverse events was higher in the coinfected (38%; 77/205) compared with the monoinfected (29%; 320/1114) group. The percentage of patients with grade 3/4 liver enzyme elevations at any time through week 48 was 14% (ALT) and 12% (AST) in the coinfected group and 1% (both ALT and AST) in the monoinfected group. Median AST to platelet ratio index (APRI) scores decreased by 29% in both groups.
  
  
  CONCLUSIONS
  Liver enzyme elevations in coinfected patients treated with FPV with or without ritonavir appear generally similar to those reported for other second-generation protease inhibitors.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, NC 27708, USA. Belinda.F.Ha@gsk.com
authors.forename: B
authors.initials: B
authors.lastname: Ha
authors.forename: B
authors.initials: B
authors.lastname: Wine
authors.forename: F
authors.initials: F
authors.lastname: Rodriguez-Alcantra
authors.forename: M
authors.initials: M
authors.lastname: Shaefer
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects*; D060085:Coinfection / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005663:Furans; D015497:HIV-1; D006509:Hepatitis B / Q000150:complications*; D006526:Hepatitis C / Q000150:complications*; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D010755:Organophosphates / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D019380:Anti-HIV Agents; D002219:Carbamates; D005663:Furans; D010755:Organophosphates; D013449:Sulfonamides; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; C426859:fosamprenavir