[Immunological, virological and clinical response in patients infected with HIV after highly active antiviral therapy with nelfinavir: prospective cohort study].
BACKGROUND
To assess the long-term effectiveness, safety and response-related factors in a cohort of HIV-infected persons receiving antiretroviral therapy containing nelfinavir. Design and setting. Prospective, non-randomized multicenter study.


METHODS
A total of 792 patients were included: 254 (32.1%) treatment-naive patients and 538 (67.9%) patients previously treated with protease inhibitors who were switched to a nelfinavir-containing regimen due to virological failure or intolerance. Factors related to virological response and to treatment failure were assessed by standard survival techniques and Cox proportional risk models.


RESULTS
Nelfinavir was well tolerated; treatment had to be interrupted in only 57 patients (7.1%) because of toxicity. During a median follow-up of 12 months, 31 patients (3.9%) experienced a new AIDS-defining event or death, and 463 (58.4%) showed immunological response. Overall, 52% patients achieved plasma HIV-1 RNA levels below 500 copies/mL (57% of naive and 49% of previously treated patients), but a high rate of virological rebound (24% and 49%, respectively) was observed. Low baseline viral load and few prior treatments were factors related to virological response. Naive treatment status and a high increase in CD4 cell count were predictive of longer viral response.


CONCLUSIONS
Highly active antiretroviral therapy with a nelfinavir-containing regimen was associated with favorable virological response in nearly half of previously treated patients, and most experienced clinical and immunological benefits. Nevertheless, the limited duration of virological response indicates the need for new alternative drugs.
de Alarcón
Arístides
A
Servicio de Enfermedades Infecciosas y Medicina Interna. Hospital Universitario Virgen del Rocío. Sevilla. Spain. aristide@cica.es
Viciana
Pompeyo
P
Lozano
Fernando
F
Vergara
Antonio
A
Pujol
Emilio
E
Barrera
Antonio
A
Pérez-Guzmán
E
E
Colmenero
Miguel Angel
MA
Hernández-Quero
José
J
Márquez
Manuel
M
de la Torre
Javier
J
Aliaga
Luis
L
Suárez
Ignacio
I
Gutiérrez-Ravé
Víctor
V
Torres-Tortosa
Manuel
M
Marín
Jorge
J
Valdayo
M J
MJ
Milla
M
M
D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019888:Nelfinavir / Q000627:therapeutic use*; D011446:Prospective Studies
D017320:HIV Protease Inhibitors; D019888:Nelfinavir