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Xavier Duval, Valérie Journot, Catherine Leport, Geneviève Chêne, Michel Dupon, Lise Cuzin, Thierry May, Philippe Morlat, Anne Waldner, Roger Salamon, François Raffi, and the Antiprotease Cohort (APROCO) Study Group, Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV-Infected Adults Initiating Protease Inhibitor—Containing Therapy, Clinical Infectious Diseases, Volume 39, Issue 2, 15 July 2004, Pages 248–255, https://doi.org/10.1086/422141
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Abstract
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 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.
- hiv
- antiretroviral therapy, highly active
- hepatitis b
- adult
- aspartate aminotransferases
- cardiovascular system
- follow-up
- hepatitis c antibodies
- indinavir
- mental disorders
- plasma
- protease inhibitor
- time factors
- transaminases
- pancreas
- renal colic
- rna
- adverse effects of medication
- creatinine clearance
- hiv infections
- laboratory test finding