13th Conference on Retroviruses and Opportunistic Infections Denver, Colorado - February 5-8, 2006

Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 17

Ross McKinney¹, M Rathore², C Hu³, P Britto³, M Smith⁴, L Serchuck⁴, J Rodman⁵, L Draper⁶, L Reynolds⁷, G Chittick⁸, and Pediatric ACTG Protocol 1021 Team
¹Duke Univ Sch of Med, Durham, NC, US; ²Univ of Florida Hlth Sci Ctr, Jacksonville, US; ³Harvard Sch of Publ Hlth, Boston, MA, US; ⁴NIH, DHHS, Bethesda, MD, US; ⁵St Jude Children's Res Hosp, Memphis, TN, US; ⁶Frontier Sci & Tech Res Fndn, Amherst, NY, US; ⁷Bristol-Myers Squibb, Wallingford, CT, US; and ⁸Gilead Sci, Durham, NC, US

BACKGROUND: Compliance with complex ART regimens is a problem for HIV-1-infected children and their families. Simple, safe, and effective regimens are important for long-term therapeutic success.

METHODS: A once-daily regimen of 3 ART drugs—emtricitabine (FTC), didanosine (ddI), and efavirenz (EFV)—was tested in 37 therapy-naïve HIV-infected children and adolescents between 3 and 21 years of age (inclusive). Subjects were followed for at least 96 weeks on an intent-to-treat basis. Signs, symptoms, plasma HIV-1 RNA viral load, CD4 counts, and safety laboratories were followed regularly. Endpoints were the proportion of subjects with plasma HIV below 400 or 50 HIV copies/mL, and safety and tolerability of the regimen.

RESULTS: We enrolled 37 subjects at 16 sites. The only adverse events leading to study drug discontinuation were 2 rashes during the first 2 weeks of therapy. Early study discontinuations included 2 incarcerations, 1 international move, 2 refusals for follow-up, and 2 viral failures on treatment. Possibly drug-related adverse events were 1 grade 4 (low glucose) and 3 grade 3 events. There were no deaths. Virologic outcomes showed promise, with 32 of 37 (85%) subjects achieving viral suppression to <400 RNA copies/mL, and 26 of 37 (72%) subjects maintaining sustained suppression at <50 copies/mL through week 96 (see the figure). The median baseline CD4 count was 310/µL (17%), which increased at week 96 by a median +329 cells/µL (by +18% CD4). Pharmacokinetic results were as predicted for FTC and ddI, while EFV concentrations in children receiving EFV oral solution were lower than anticipated, requiring a dose escalation after the initial planned assessment point.

CONCLUSIONS: A once-daily regimen of FTC, ddI, and EFV proved to be safe and effective in this 37 subject, 2-year phase I/II study. By intent-to-treat analysis, 72% of subjects demonstrated sustained HIV viral load suppression to <50 copies/mL through week 96.

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2006-02-05
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