Switching to a Nevirapine-Based Regimen Feasible in Children Previously Exposed to Single-Dose Nevirapine: Presented at IAS
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Switching to a Nevirapine-Based Regimen Feasible in Children Previously Exposed to Single-Dose Nevirapine: Presented at IAS

By Charlene Laino

CAPE TOWN, South Africa -- July 23, 2009 -- HIV-positive children who have been exposed to a single-dose of nevirapine before birth can maintain viral suppression if they are switched to a nevirapine-based antiretroviral regimen, according to a study presented here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.

Ashraf Coovadia, MD, Department of Paediatrics and Child Health, University of the Witwatersrand, Coronation Women and Children Hospital, Johannesburg, South Africa, presented the findings of the Nevirapine Resistance Study (NEVEREST) on July 20.

Current guidelines call for initiating a protease inhibitor (PI)-based regimen in infants exposed to single-dose nevirapine, but these regimens are more costly and have greater long-term toxicities than non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens, said Dr. Coovadia.

Therefore, Dr. Coovadia and colleagues set out to determine the feasibility of switching from a protease inhibitor-based regimen to an NNRTI-based regimen in children previously exposed to single-dose nevirapine.

The study involved 195 HIV-positive children aged younger than 2 years whose mother had taken nevirapine to prevent mother-to-child transmission. The children were started on a regimen consisting of lopinavir/ritonavir in combination with stavudine and lamivudine.

After maintaining a viral load <400 copies/mL for 3 months or more, 99 children were randomised to continue on their current regimen, and 96 children were given nevirapine in place of lopinavir/ritonavir.

A total of 56.2% of children in the nevirapine arm consistently had a viral load <50 copies/mL for 52 weeks, compared with 42.4% of children who remained on lopinavir/ritonavir (P = .01).

Of the children treated with lopinavir/ritonavir, 98% maintained a viral load <1,000 copies/mL throughout the year, compared with 80% in the nevirapine arm (P = .007). This suggests that the difference in the proportion with viral load <50 copies/mL may have been due by poorer adherence to the PI, Dr. Coovadia said.

Factors that predicted sustained viral suppression in children who switched to nevirapine were having a viral load of <50 copies/mL at randomisation and having no NNRTI mutations at baseline.

Two children in both arms died.

The researchers called for further study of NNRTI-based regimens in children.

[Presentation title: Randomized Clinical Trial of Switching to Nevirapine-Based Therapy for Infected Children Exposed to Nevirapine Prophylaxis. Abstract MOAB103]

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