12th Conference on Retroviruses and Opportunistic Infections Boston, Massachusetts - February 22-25, 2005

Conf Retrovir Opportunistic Infect 2005 Feb 22-25;12:abstract no. 50

Thanyawee Puthanakit¹, A Oberdorfer¹, N Akarathum², S Kanjanavanit², P Wannarit³, R Chaiwarith¹, and T Sirisanthana^1
1Chiang Mai Univ, Thailand; ²Ministry of Publ Hlth, Chiang Mai, Thailand; and ³Ministry of Publ Hlth, Lamphun, Thailand

BACKGROUND: Thailand’s national program for access to ART in HIV-infected patients has been implemented since 2002. This study aimed to determine the effectiveness of nevirapine (NVP)- and efavirenz (EFV)-based HAART in advanced-stage, ART-naïve children participating in the Thai national access program.

METHODS: From August 2002 to May 2003, 96 HIV-infected ART-naïve children, whose CD4 cells = 15% were enrolled. NVP-based HAART employed a generic non-pediatric fixed-dose combination of stavudine (d4T), lamivudine (3TC), and NVP (n = 51). EFV-based HAART utilized non-pediatric pills of d4T, 3TC, and EFV (n = 45). The drug dosage was calculated based upon the child’s body weight. Pills were divided into quarters or halves if necessary. All patients have been followed for >72 weeks. Primary endpoint was the percentage of patients with HIV RNA (plasma viral load) < 50 copies/mL at week 72. Secondary endpoints were the change in percentage of CD4 and the incidence of resistance mutation virus.

RESULTS: At baseline, the mean age was 7.9 years (range 2.0 to 13.8), the mean adjusted weight z-score was –1.9 (0.9) and height z-score was –2.4 (SD 1.4). The median percentage of CD4 was 4 % (IQR 1 to 10), and the mean plasma viral load was 5.4 (SD 0.5) log₁₀ copies/mL. In the first 2 weeks of treatment, 5 patients who received NVP-based HAART developed severe adverse drug reactions and were switched to EFV-based regimen; 4 patients died from HIV-related illness (NVP 1, EFV 3). Adherence rate of ≥ 95% of prescribed dose at every visit was reported in 86% of patients. In an intention-to-treat analysis, plasma viral load was undetectable in 74% of patients (NVP 59%, EFV 91%; p < 0.001). At week 72, the median percentage of CD4 was 21 % (IQR 15 to 25). Children with virologic success had significantly higher percentage of CD4 at week 72 (21% vs 15%, p = 0.02). The mean adjusted weight and height z-score significantly increased to –1.4 (SD 0.9) and –2.1 (SD 1.3), respectively; 14 patients (NVP 12, EFV 2) developed resistance mutation virus. The most common resistance mutation pattern was that which conferred resistance to both 3TC and NNRTI.

CONCLUSIONS: This study showed that NNRTI-based HAART is an effective regimen for HIV-infected children despite initiation of treatment in the advanced stage of disease. The use of generic fixed-dose formulations and non-pediatric formulations are feasible and effective in resource-limited settings.

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