Abstract
BackgroundThe clinical data of plasma NVP level, safety and efficacy of antiretroviral therapy (ART) for the concurrent use of nevirapine (NVP)-based ART and fluconazole (FLU) is scanty.MethodsA retrospective study was conducted in patients who were initiated NVP-based ART between October 2004 and November 2005. The objectives were to compare NVP levels, adverse events, and 36-week efficacy of NVP-based ART between patients who did not receive FLU (group A) and those who received FLU 200 mg/day or 400 mg/day (group B).ResultsThere were 122 patients with mean ± SD age of 36 ± 9 years; 81 in group A and 41 in group B. Median (IQR) baseline CD4 cell count was 29 (8–79) cell/mm3 in group A and 19 (8–33) cell/mm3 in group B (P = 0.102). Baseline characteristics between the two groups were similar. Mean ± SD NVP levels were 6.5 ± 3.0 mg/L in group A and 11.4 ± 6.1 mg/L in group B(P < 0.001). One (2.4%) patient in group B developed clinical hepatitis (P = 0.336). Six (7.4%) patients in group A developed NVP-related skin rashes (P = 0.096). There were no differences in term of 36-week antiviral efficacy between the two groups (P > 0.05).ConclusionCo-administration of NVP and daily dosage of FLU (200 mg/day and 400 mg/day) results in markedly increased trough plasma NVP level when compared to the administration of NVP alone. The concurrent use of NVP and FLU in very advanced HIV-infected patients is well-tolerated. The immunological and virological responses are favorable.
Highlights
The clinical data of plasma NVP level, safety and efficacy of antiretroviral therapy (ART) for the concurrent use of nevirapine (NVP)-based ART and fluconazole (FLU) is scanty
Current guidelines recommend the use of high dose of amphotericin B 0.7–1.0 mg/kg/day combined with flucytosine 100 mg/kg/day during the first two weeks of treatment
We demonstrate that co-administration of NVP and daily dosage of FLU (200 mg/day and 400 mg/day) results in markedly increased trough plasma NVP level when compared to the administration of NVP alone
Summary
The clinical data of plasma NVP level, safety and efficacy of antiretroviral therapy (ART) for the concurrent use of nevirapine (NVP)-based ART and fluconazole (FLU) is scanty. Before the era of combined active antiretroviral therapy (ART), approximately 5%– 8% of HIV-infected patients in developed countries (page number not for citation purposes). The incidence has substantially declined after the era of combined effective ART. It is still a major problem in developing countries [3,4,5]. Current guidelines recommend the use of high dose of amphotericin B 0.7–1.0 mg/kg/day combined with flucytosine 100 mg/kg/day during the first two weeks of treatment. Amphotericin B and flucytosine can be discontinued and consolidation therapy with fluconazole (FLU) 400 mg/day for a minimum of eight weeks is recommended [7]. FLU is the preferred azole drug for systemic treatment of candidiasis and coccidioidomycosis [11]
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