Journal Article

Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV-Infected Adults Initiating Protease Inhibitor—Containing Therapy

Xavier Duval, Valérie Journot, Catherine Leport, Geneviève Chêne, Michel Dupon, Lise Cuzin, Thierry May, Philippe Morlat, Anne Waldner, Roger Salamon and François Raffi

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 39, issue 2, pages 248-255
Published in print July 2004 | ISSN: 1058-4838
Published online July 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/422141
Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV-Infected Adults Initiating Protease Inhibitor—Containing Therapy

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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 ⩾5 log10 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.

Journal Article.  3884 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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