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Colegio de Medicina Interna de México.

2005, Number 5

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Med Int Mex 2005; 21 (5)

Initial therapy with lopinavir-ritonavir in HIV-infected naïve patients in common daily practice

Ayala GJJ, Zapata DER, Valdovinos CSB, González MPM

Language: Spanish
References: 22
Page: 323-329
PDF size: 64.83 Kb.


ABSTRACT

Objective: To assess tolerance and antiviral effect of lopinavir/ritonavir (LPV/r) based regimen with a two nucleoside reverse transcriptase inhibitors (NRTI) backbone given to a group of HIV-infected naïve patients.
Patients and methods: In an infectious diseases outpatient service at a tertiary level hospital in Northeastern Mexico it was performed a cohort pilot study. Naïve HIV adult infected patients, with T CD4+ lymphocyte count of ‹350 cells/mm3 and viral load (VL): plasma HIV-RNA copies/mL ›55,000, with or without AIDS defining conditions, patients were started with LPV/r (Kaletra®) and a zidovudine/lamivudine (Combivir®) backbone. Patients were assessed each four weeks during a period of 48. Study variables were the proportional number of patients with plasma HIV-RNA of ‹400 copies/mL (UDVL) at 12, 24, 36 and 48 weeks; change in T CD4+ lymphocyte count, emergence of AIDS defining conditions and/or death. Drug toxicity was also assessed.
Results: 20 patients were included, in 16 (80%), CD4+ counts were ‹200 cells/mm3, 11 patients (55%) had baseline plasma HIV-RNA ›100,000 copies/mL, one patient carried HBV antigen. On week 24 (IT), eighteen patients (90%) reached sustained UDVL along the follow up; one patient left the study after the first visit, and one patient with Kaposi’s sarcoma died. Mean lymphocyte T CD4+ count on weeks 24 and 48 was respectively 141 and 197 cells/mm3. No patient was withdrawn because of drug toxicity. Two patients developed severe anemia associated to zidovudine, and was substituted with stavudine. In general LPV/r was well tolerated; during the first trimester mild to moderate nausea and loose stools appeared. Mean of total cholesterol rose from 155 mg/dL to 205 mg/dL and triglycerides from 199 mg/dL to 235 mg/dL, liver tests remained unaltered.
Conclusion: As a first regimen, LPV/r with a backbone of 2 NRTIs developed a potent antiretroviral effect, also induced a good immune response and was well tolerated.


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