Incidence of and risk factors for adverse drug reactions in a prospective cohort of HIV-infected adults initiating protease inhibitor-containing therapy.
Risk factors associated with the occurrence of protease inhibitor (PI)-related severe and serious adverse drug reactions (SADRs) were analyzed in a prospective cohort of 1155 patients who initiated PI-containing therapy. During a total follow-up of 2037 patient-years, 169 SADRs were reported, yielding a rate of 8 incidents per 100 patient-years (95% confidence interval [CI], 6.8-8.6). The most frequent SADRs were elevated transaminase levels (in 49 events); renal colic (27); abnormal hematological findings (23); and metabolic (18), neuromuscular (7), pancreatic (6), cutaneous (6), cardiovascular (5), and psychiatric disorders (5). Among baseline characteristics, plasma human immunodeficiency virus RNA levels of >or=5 log(10) copies/mL (hazard ratio [HR], 1.5; 95% CI, 1.1-2.2), elevated aspartate aminotransferase levels (HR, 1.1 for each 20 IU of elevation; 95% CI, 1.1-1.2), creatinine clearance levels of <70 mL/min (HR, 2.1; 95% CI, 1.2-3.7), test results positive for hepatitis C virus antibodies or hepatitis B surface antigenemia (HR, 2.6; 95% CI, 1.8-3.7), and receipt of indinavir (HR, 1.7; 95% CI, 1.2-2.4) were independently predictive of a SADR. SADRs were frequent in the first 4 months after initiation of highly active antiretroviral therapy but continued to occur after that time period.
Laboratoire de Recherche en Pathologie Infectieuse, Faculté Xavier Bichat, Paris, France.
Xavier
X
Duval
Valérie
V
Journot
Catherine
C
Leport
Geneviève
G
Chêne
Michel
M
Dupon
Lise
L
Cuzin
Thierry
T
May
Philippe
P
Morlat
Anne
A
Waldner
Roger
R
Salamon
François
F
Raffi
D000328:Adult; D003085:Colic / Q000139:chemically induced; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects*; D006525:Hepatitis, Viral, Human / Q000150:complications; D006801:Humans; D015994:Incidence; D019469:Indinavir / Q000009:adverse effects; D007674:Kidney Diseases / Q000139:chemically induced; D008297:Male; D011336:Probability; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000150:complications; D012307:Risk Factors; D013997:Time Factors; D000637:Transaminases / Q000097:blood
D017320:HIV Protease Inhibitors; D019469:Indinavir; D000637:Transaminases