Objective: This consensus document is an update of antiretroviral therapy recommendations for adult patients with human immunodeficiency virus (HIV) infection.
Methods: To formulate these recommendations, a panel comprised of members of the Grupo de Estudio de Sida (Gesida, AIDS Study Group) and the Plan Nacional sobre el Sida (PNS, Spanish AIDS Plan) reviewed the advances in current understanding of the pathophysiology of HIV infection, and the efficacy and safety results from clinical trials, cohort studies, and pharmacokinetic studies published in biomedical journals or presented at scientific meetings over the last 2 years. Three levels of evidence were defined according to the data source: randomized studies (level A), cohort or case-control studies (level B), and expert opinion (level C). The decision to recommend, consider, or not recommend antiretroviral therapy (ART) was established in each situation.
Results: The current treatment of choice for chronic HIV infection is a combination of 3 drugs from 2 different classes; that is, 2 nucleoside or nucleotide analogs (NRTI) plus 1 non-nucleoside (NNRTI) or 1 boosted protease inhibitor (PI/r). ART initiation is recommended in patients with symptomatic HIV infection. In asymptomatic patients, initiation of ART is recommended on the basis of CD4 lymphocyte counts, plasma viral load and the patient's comorbid conditions, as follows: a) therapy should be started in patients with CD4 counts of <350 cells/microl; b) when CD4 count is between 350 and 500 cells/microl, therapy should be started in patients with chronic hepatitis C or cirrhosis, coinfection with hepatitis B requiring treatment, high cardiovascular risk, HIV nephropathy, HIV viral load >10(5)copies/ml, or<14% CD4 cells; c) therapy should be deferred when CD4 count is >500 cells/microl, but can be considered if any of the previous circumstances concur. The objective of ART is to achieve an undetectable viral load. Adherence to therapy plays an essential role in maintaining antiviral response. Therapeutic options are limited after ART failures, but undetectable viral load may be possible with new drugs, even in highly drug-experienced patients. Genotype studies are useful in these situations. Drug toxicity from ART therapy is losing importance as benefits exceed adverse effects.
Conclusions: CD4 cell count, viral load, and patient comorbidities are the most important reference factors to consider when initiating ART in asymptomatic patients. The large number of available drugs, the increasing sensitivity of tests to monitor viral load, and the ability to determine viral resistance is leading to a more individualized therapy approach, with the goal of achieving undetectable viral load in any circumstance. The complete version of the recommendations can be found on the Gesida (http://www.gesida.seimc.org) or PNS (http://www.msc.es/ciudadanos/enfLesiones/enfTransmisibles/sida/home.htm) web sites.