AEGiS-13IAC: Sustained efficacy of nevirapine (NVP) in combination with two nucleosides in advanced, treatment-naive HIV infected patients with high viral loads: A BI 1090 substudy.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Sustained efficacy of nevirapine (NVP) in combination with two nucleosides in advanced, treatment-naive HIV infected patients with high viral loads: A BI 1090 substudy.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB604)

Wood R; R. Wood, HIV Clinic, Somerset Hospital, Greenpoint 8001, Capetown, South Africa, Tel.: +27 11 27 11 402 6911, Fax: +27 11 27 11 252 021, E-mail: rcurry@boehringer-ingelheim.com

BACKGROUND: Study BI 1090 was a 2256 patient international clinical endpoint comparison study of NVP versus placebo on a background of antiretroviral medication. CD4+ counts and HIV RNA copy number were assessed to evaluate the effect of NVP.

METHODS: Plasmas from the first 171 antiretroviral-naive patients (77 NVP, 94 placebo) using ZDV/3TC as their antiretroviral background were assayed. Analyses included response to below limit of detection (BLD, limit of detection 50 c/mL) at 6 months and 12 months for HIV RNA and CD4+ count. Patients were considered evaluable if they were observed during the 16 to 32 week (6 month) or the 40 to 56 week (12 month) time windows. Intent-to-treat (ITT) analysis that considers all non-evaluable patients as failures is displayed in brackets ' '.

RESULTS: The Republic of South Africa had the highest enrollment with 71% of patients in this substudy. Baseline HIV RNA was 142,883 c/mL (geometric mean) 174,708 c/mL (median); baseline CD4+ count was 97 cells/mm³ (mean), 84 cells/mm³ (median). At 6 months and 12 months, 71% (46/65) '60%' and 65% (34/52) '44% ' of evaluable NVP patients were BLD, compared to 6% (4/65) '4% ' and 0% (0/42) '0% ' of evaluable placebo patients. At 6 and 12 months, evaluable NVP patients had mean CD4+ count changes of 98 cells/mm³ (N = 66) and 137 cells/mm³ (N = 58), compared to 55 cells/mm³ (N = 72) and 54 cells/mm³ (N = 51) for evaluable placebo patients. NVP was statistically significantly superior to placebo for all comparisons (p>0.05).

CONCLUSION: Sustained suppression of plasma HIV RNA with associated improvement in CD4+ count was achieved with NVP/ZDV/3TC in advanced antiretroviral- naive patients with high viral loads.

Keywords: AEGIS, Nevirapine, Viral Load, HIV Infections, CD4 Lymphocyte Count, Zidovudine, Lamivudine, Antiretroviral Therapy, Highly Active, HIV Seropositivity, Drug Therapy, Combination, South Africa, Human, therapy, pathogenicity, drug therapy
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WeOrB604