Incidence of and risk factors for adverse drug reactions in a prospective cohort of HIV-infected adults initiating protease inhibitor-containing therapy.

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 >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.

• Authors: Xavier Duval, Valérie Journot, Catherine Leport, Geneviève Chêne, Michel Dupon, Lise Cuzin, Thierry May, Philippe Morlat, Anne Waldner, Roger Salamon, François Raffi, Antiprotease Cohort (APROCO) Study Group
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 39 Issue 2 Pg. 248-55 (Jul 15 2004) ISSN: 1537-6591 [Electronic] United States
• PMID: 15307035 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• HIV Protease Inhibitors
• Indinavir
• Transaminases

Topics

• Adult
• Colic (chemically induced)
• Female
• HIV Infections (complications, drug therapy)
• HIV Protease Inhibitors (adverse effects)
• Hepatitis, Viral, Human (complications)
• Humans
• Incidence
• Indinavir (adverse effects)
• Kidney Diseases (chemically induced)
• Male
• Probability
• Prospective Studies
• Renal Insufficiency (complications)
• Risk Factors
• Time Factors
• Transaminases (blood)