Dual efficacy of lamivudine treatment in human immunodeficiency virus/hepatitis B virus-coinfected persons in a randomized, controlled study (CAESAR). The CAESAR Coordinating Committee.
The efficacy and safety of lamivudine in persons coinfected with human immunodeficiency virus (HIV) type 1 and hepatitis B virus (HBV) were examined in the CAESAR study, a randomized placebo-controlled trial assessing the addition of lamivudine (150 mg 2x/day) or lamivudine (150 mg 2x/day) plus loviride (100 mg 3x/day) to zidovudine-containing background antiretroviral treatment. Baseline hepatitis B surface antigen (HBsAg) results were available for 1790 study subjects, of whom 122 (6.8%) tested positive. Retrospective analyses for serial HBV DNA, HBsAg, and hepatitis B e antigen (HBeAg) were performed on stored sera from 118 HBsAg-positive subjects. HBV DNA and HBeAg were present in 83% and 63%, respectively. At weeks 12 and 52, median log10 HBV DNA change was -2.0 and -2.7, respectively, in the lamivudine arms, compared with no reduction among placebo recipients (P<.001). A trend to lower alanine transferase level, and delayed progression of HIV-1 disease (relative hazard, 0.26; 95% confidence interval, 0.08-0.80) were also seen in the lamivudine arms, compared with the placebo group.
Dore
G J
GJ
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia. gdore@nchecr.unsw.edu.au
Cooper
D A
DA
Barrett
C
C
Goh
L E
LE
Thakrar
B
B
Atkins
M
M
D000081:Acetamides / Q000627:therapeutic use*; D000098:Acetophenones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D015497:HIV-1; D006509:Hepatitis B / Q000150:complications* / Q000188:drug therapy*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012189:Retrospective Studies; D013997:Time Factors
D000081:Acetamides; D000098:Acetophenones; D019380:Anti-HIV Agents; D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D010919:Placebos; D019259:Lamivudine; C080073:loviride