2005, Number 2
MexVir 1: comparison of two antiretroviral schemes including nelfinavir in Mexican patients with HIV infection: a national, multicenter, 48-week follow-up
Curiel HO, Arreola PMA, Jáuregui CM, Rodríguez SR, Cano DC, Torres IR, Rascón HO, López GP, Herver CMJ, Hernández JM, Pérez SG, Wong GS, Encinas AJ, Ramos SC, Vargas MJD, Méndez CP, Muñoz RCG, Dávila BA, García CL, Juárez KI, Pérez SU, Luis PC, Ilizaliturri SS, Vega YA, Flores FL, Vázquez M, Mancera AA
Full text
Language: Spanish
References: 11
Page: 106-122
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ABSTRACT
Background: Sequencing of antiretroviral therapy has shown benefits on HIV/AIDS-patients’ survival. Nelfinavir is a protease inhibitor that supports this kind of treatment, and that has shown long-term effectiveness and safety.Objective: To describe experience gained in Mexico using nelfinavir in antiretroviral therapy on HIV-infected patients.
Material and methods: This is a randomized, prospective, longitudinal clinical trial to determine effectiveness and safety of nelfinavir (NFV) with two regimes of nucleoside analogs (ZDV+3TC or ZDV+ddC). A total of 1,035 Mexican patients where divided into two groups (ZDV+3TC+NFV, n = 466 vs ZDV+ddC+NFV, n = 569). Viral load, CD4 cell count, basic laboratory tests, such as blood count, transaminases, triglycerides, cholesterol, and renal function tests were performed. An analysis of initial data at 24 weeks (6 months) and 48 weeks (12 months) was carried out. Patient evolution was compared from initial observation up to 48 weeks; subsequently, effectiveness and safety were compared between the two groups.
Results: No differences were observed in epidemiologic variables among the two groups. Diagnosis time intervals were very similar; however, more advanced disease stages were observed in the ddC group, with no significant difference. Effectiveness of both regimes was comparable, from an immunological (CD4 recovery; ddC group, 119 cells vs 3TC group, 180 cells) and viral point of view (viral suppression ddC 1.56 log10 vs 3TC 1.46 log10). Side effects were also similar between the two groups; there were non-serious adverse events resulting from study drugs. Main adverse events were: gastrointestinal (same for the two groups); neuropathy, slightly higher in ddC group and hypertriglyceridemia, similar in both groups (p=0.05, with no clinical significance). Withdrawal and death rates remained under 5%, and were associated to the stage of the disease, not to the study treatment.
Conclusion: This multicenter study represents the experience gained in Mexico with the use of nelfinavir, as a part of a HAART (highly active antiretroviral therapy) regime. These results are consistent with those of a study carried out in 2003 with the protease inhibitor saquinavir; further Mexican reports are required on experience with different protease inhibitors, in order to establish the best procedures for patients with HIV in our country.
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