title: Virologic outcome and predictors of virologic failure of highly active antiretroviral therapy containing protease inhibitors.
abstract: In this observational single-center cohort study outside the clinical trial setting, outcome and predictors of virologic failure of highly active antiretroviral therapy (HAART) containing a protease inhibitor were evaluated in human immunodeficiency (HIV)-infected persons. The study population consisted of 807 protease inhibitor-naive HIV-seropositive patients who initiated antiretroviral therapy with reverse transcriptase inhibitors and protease inhibitors (indinavir, nelfinavir, ritonavir) between January 1997 and January 1999. Demographic variable, plasma HIV-1 RNA levels, CD4+ T-cell count, adverse drug reactions, and adherence to HAART were assessed. Virologic treatment response was defined as a decrease in plasma HIV-1 RNA load from baseline to below 500 copies per milliliter after 12 months of therapy. Levels of HIV-1 RNA were undetectable in 43% of patients at 12 months. Factors associated with failure to suppress viral load included age 40 years or younger, baseline CD4+ T cell count less than 200 x 10(6) per liter baseline viral load greater than 4.3 log(10) per milliliter, and non-adherence to HAART. After adjustment by logistic regression, non-adherence was the only statistically significant variable associated with virologic failure (odds ratio 0.38, 95% confidence interval 0.21 to 0.67). Unselected patients in whom protease inhibitor is started in a usual clinical setting achieve viral suppression less frequently than do patients in controlled clinical trials. Failure to adherence to HAART was the strongest predictor of virologic failure.
authors.affiliation: Department of Internal Medicine-Infectious Diseases, Autonomous University of Barcelona, Barcelona, Spain. 87138@imas.imim.es
authors.forename: H
authors.initials: H
authors.lastname: Knobel
authors.forename: A
authors.initials: A
authors.lastname: Guelar
authors.forename: A
authors.initials: A
authors.lastname: Carmona
authors.forename: M
authors.initials: M
authors.lastname: Espona
authors.forename: A
authors.initials: A
authors.lastname: González
authors.forename: J L
authors.initials: JL
authors.lastname: López-Colomés
authors.forename: P
authors.initials: P
authors.lastname: Saballs
authors.forename: J L
authors.initials: JL
authors.lastname: Gimeno
authors.forename: A
authors.initials: A
authors.lastname: Díez
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011237:Predictive Value of Tests; D011480:Protease Inhibitors / Q000627:therapeutic use*; D013030:Spain; D016312:Treatment Refusal; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D011480:Protease Inhibitors