[Spanish GESIDA/Nacional AIDS Plan Recommendations for antiretroviral therapy in HIV-infected Adults (October 2004)].
OBJECTIVE
This consensus document is an update of antiretroviral therapy (ART) recommendations for adult patients infected with the human immunodeficiency virus (HIV).


METHODS
To formulate these recommendations, a panel composed 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, the safety and efficacy findings from clinical trials, and the results from cohort and pharmacokinetic studies published in biomedical journals or presented at scientific meetings over the last years. Three levels of evidence were defined according to the source of the data: randomized studies (level A), cohort or case-control studies (level B), and expert opinion (level C). The decision to recommend, consider or not recommend ART was established in each of these situations.


RESULTS
ART consisting of at least three drugs is currently the initial treatment of choice for chronic HIV infection. These regimens should include 2 NRTI + 1 NNRTI or 2 NRTI + 1 PI. Initiation of ART is recommended in patients with symptomatic HIV infection. In asymptomatic patients, initiation of ART is recommended on the basis of CD4+ lymphocyte counts per L and plasma viral load, as follows: 1) Therapy should be started in patients with CD4+ counts of < 200 cells/microL; 2) Therapy should be started in most patients with CD4+ counts of 200-350 cells/microL, although it can be delayed when CD4+ count persists at around 350 cells/microL and viral load is low; and 3) Initiation of therapy can be delayed in patients with CD4+ counts of > 350 cells/microL. The initial objective of ART is to achieve an undetectable viral load. Adherence to therapy plays an essential role in maintaining the antiviral response. Because of the development of cross resistance, therapeutic options are limited when ART fails. Genotype studies are useful in these cases. Toxicity is a limiting factor in the use of ART, although the benefits outweigh the risks. In addition, the criteria for the use of ART are discussed in situations of acute infection, pregnancy, and post-exposure prophylaxis, and in the management of co-infection of HIV with HCV or HBV.


CONCLUSIONS
CD4+ lymphocyte count is the most important reference factor for initiating ART in asymptomatic patients. The large number of available drugs, the increased sensitivity of tests to monitor viral load, and the possibility to determine viral resistance is leading to a more individualized approach to therapy.
Iribarren
José Antonio
JA
Hospital Donostia, San Sebastián, Spain. jiribarr@telefonica.net
Labarga
Pablo
P
Rubio
Rafael
R
Berenguer
Juan
J
Miró
José M
JM
Antela
Antonio
A
González
Juan
J
Moreno
Santiago
S
Arrizabalaga
Julio
J
Chamorro
Lourdes
L
Clotet
Bonaventura
B
Gatell
José M
JM
López-Aldeguer
José
J
Martínez
Esteban
E
Polo
Rosa
R
Tuset
Montserrat
M
Viciana
Pompeyo
P
Santamaría
Juan Miguel
JM
Kindelán
José María
JM
Ribera
Esteve
E
Segura
Ferrán
F
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy; D000208:Acute Disease; D044966:Anti-Retroviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002908:Chronic Disease; D018450:Disease Progression; D004347:Drug Interactions; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D010349:Patient Compliance; D011247:Pregnancy; D011480:Protease Inhibitors / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use
D044966:Anti-Retroviral Agents; D011480:Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors