Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine

Chokephaibulkit, Kulkanya; Plipat, Nottasorn; Cressey, Tim R.; Frederix, Koen; Phongsamart, Wanatpreeya; Capparelli, Edmund V.; Kolladarungkri, Teera; Vanprapar, Nirun

doi:10.1097/01.aids.0000183625.97170.59

Cited by 45 publications

(32 citation statements)

References 11 publications

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“…In a Thai study [18], only 3% of children (one of 34) who received divided adult FDCs (GPO-VIR S30; GPO, Thailand; equivalent to Triomune 30) had subtherapeutic nevirapine concentrations (defined as < 3.4 mg/l) and the average nevirapine dose was considerably higher at 328 mg/m 2 [18] compared with 265 mg/m 2 in our previous study [3]. The average age was, however, higher and none were less than 3 years (compared with 13% in our previous study), nor did any receive quarter or threequarter tablets (compared with 42%) [3].…”

Section: Discussionmentioning

confidence: 99%

Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets

L'homme

Kabamba

Ewings

et al. 2008

Aids

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Section: Discussionmentioning

confidence: 99%

Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets

L'homme

Kabamba

Ewings

et al. 2008

Aids

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“…8,10,11 The majority of patients in our cohort were treated with split adult FDC of 2 NRTIs and 1 NNRTI, confirming other findings that good outcomes can be achieved with this treatment strategy. 18,19 It should be noted, however, that this practice is a suboptimal interim strategy 13 pending prequalification of pediatric formulations of FDCs. The majority of the patients were in an advanced stage of HIV infection, similar to many settings where HIV/AIDS care for children has been commenced.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Highly Active Antiretroviral Therapy in HIV-Positive Children: Evaluation at 12 Months in a Routine Program in Cambodia

Janssens¹,

Raleigh²,

Soeung

et al. 2007

Pediatrics

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OBJECTIVE. Increasing access to highly active antiretroviral therapy to reach all those in need in developing countries (scale up) is slowly expanding to HIV-positive children, but documented experience remains limited. We aimed to describe the clinical, immunologic, and virologic outcomes of pediatric patients with >12 months of highly active antiretroviral therapy in 2 routine programs in Cambodia. METHODS. Between June 2003 and March 2005, 212 children who were younger than 13 years started highly active antiretroviral therapy. Most patients started a standard first-line regimen of lamivudine, stavudine, and nevirapine, using split adult fixed-dosage combinations. CD4 percentage and body weight were monitored routinely. A cross-sectional virologic analysis was conducted in January 2006; genotype resistance testing was performed for patients with a detectable viral load. RESULTS. Mean age of the subjects was 6 years. Median CD4 percentage at baseline was 6. Survival was 92% at 12 months and 91% at 24 months; 13 patients died, and 4 were lost to follow-up. A total of 81% of all patients had an undetectable viral load. Among the patients with a detectable viral load, most mutations were associated with resistance to lamivudine and non–nucleoside reverse-transcriptase inhibitor drugs. Five patients had developed extensive antiretroviral resistance. Being an orphan was found to be a predictor of virologic failure. CONCLUSIONS. This study provides additional evidence of the effectiveness of integrating HIV/AIDS care with highly active antiretroviral therapy for children in a routine setting, with good virologic suppression and immunologic recovery achieved by using split adult fixed-dosage combinations. Viral load monitoring and HIV genotyping are valuable tools for the clinical follow-up of the patients. Orphans should receive careful follow-up and extra support.

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“…The investigators concluded that dividing FDC Triomune should be used with caution to avoid inappropriate dosing and that further study is needed on the effects of malnutrition on NVP pharmacokinetics in children. However in Thailand, good virologic and immunologic response as well as appropriate NVP exposure has been reported among children treated with adult fixed dose combinations of stavudine, lamivudine, and nevirapine (GPO-VIR) 31 . In spite of the disadvantages of using adult FDC to treat children, our data show that children can be effectively treated with adult FDC up to 96 weeks of treatment.…”

Section: Discussionmentioning

confidence: 99%

The long-term effectiveness of generic adult fixed-dose combination antiretroviral therapy for HIV-infected Ugandan children

Barlow-Mosha¹,

Bagenda²,

Mudiope³

et al. 2013

Af Hlth Sci

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Background: Access to pediatric antiretroviral formulations is increasing in resource-limited countries, however adult FDCs are still commonly used by antiretroviral therapy (ART) programs. Objective: To describe long-term effectiveness of using adult FDC of d4T+3TC+NVP (Triomune) in children for HIV treatment. Methods: Clinical, immunologic, and virologic outcomes of HIV-infected ART-naïve children aged six months to 12 years, were evaluated up to 96 weeks post-ART initiation. Results: From March 2004 to June 2006, 104 children were followed with a median age of 5.4 years, median CD4 cell percent and HIV-1 RNA were 11.0% (IQR 6.7-13.9) and 348,846copies/mL (IQR 160,941-681,313) respectively at baseline. Using Kaplan-Meir estimates, 75% of children had undetectable viral loads (<400copies/mL) at 96weeks of ART. Children with a baseline CD4 cell percent >15% were 3 times more likely to achieve viral load <400copies/mL than those with baseline CD4 cell percent <5% after adjusting for baseline age {aHR = 3.03 (1.10-8.32), p=0.03}; no difference was found among those with CD4 cell percent >5-14.9% and <5%. Conclusion: Treatment with generic adult FDC for HIV-infected Ugandan children led to sustained clinical, immunologic and virologic response during 96 weeks of ART. Early initiation of ART is key to achieving virological success.

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Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine

Cited by 45 publications

References 11 publications

Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets

Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets

Effectiveness of Highly Active Antiretroviral Therapy in HIV-Positive Children: Evaluation at 12 Months in a Routine Program in Cambodia

The long-term effectiveness of generic adult fixed-dose combination antiretroviral therapy for HIV-infected Ugandan children

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