AEGiS-13IAC: An open Label study to compare Efficacy and Safety of the Triple Nucleoside Analog Combination Combivir (COM)/Abacavir (ABC) versus a Protease Inhibitor (PI) Containing Regimen in Antiretroviral Therapy (ART) Naive adults CNAF3007/Ecureuil.

13th International AIDS Conference

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

An open Label study to compare Efficacy and Safety of the Triple Nucleoside Analog Combination Combivir (COM)/Abacavir (ABC) versus a Protease Inhibitor (PI) Containing Regimen in Antiretroviral Therapy (ART) Naive adults CNAF3007/Ecureuil.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB605)

Matheron S, Brun-Vezinet F, Viraben R, Malkin JE, Troisvallets D, Lafeuillade A, Thiaux C, Mamet JP
S. Matheron, Hosp.Bicat, 46,rue Henri Huchard, 75877 paris, France, Tel.: +33 1 40 257 809, Fax: +33 1 42 295 300, E-mail: ct6916@ggr.co.uk

OBJECTIVE: To evaluate COM/ ABC as first line therapy in HIV-1 infected adults, in place of a PI containing triple combination.

METHODS: ART naive adults, with a plasma HIV-1 RNA (pVL) between 1000 and 500000 cp/ml were randomized to receive either COM (3TC150mg/ZDV300mg) bid + ABC (300mg) bid or COM bid + Viracept (NFV) (750mg) q8h for 48weeks (w). pVL (Roche Amplicor > 50 cp/ml), CD4+ cell count, clinical, biological adverse events, and adherence to regimen were assessed at baseline, w 4,8,16,24,32,40 and 48.

RESULTS: 195 subjects, median age 34 years (18-68), 131 males, 64 females, were randomised, 98 subjects to COM/ABC and 97 to COM/NFV. At baseline pVL was comparable in both groups with a median pVL of 4.2 log₁₀ (1.7-5.4).Median CD4+cell count/mm³ was lower at baseline in COM/ABC (387 (10-1038)) than in COM/NFV (449 (29-1133)) (p > 0.004). In this intent to treat analysis, 78% and 74% of subjects had pVL> 50 cp/ml in COM/ABC and COM/NFV respectively and 83% and 80% of subjects had pVL> 400 cp/ml. % of subjects with pVL>50 cp/ml and without switch of study drug, was 67% in both groups. Median change from baseline in pVL was -2.4 log₁₀ (-3.5; 0.5) in both group. Median CD4+ cell count increase was 90 (-168, +701) in COM/ABC and 75 (-767, +741) in COM/NFV. Number of subjects experiencing > = 1 drug related Serious Adverse Event (SAE) was similar in both groups (3 in COM/ABC, 2 in COM/NFV), excluding hypersensitivity reaction to ABC (4 cases reported). 7 subjects (4%) permanently discontinued > = 1 study drug as a result of an SAE.

CONCLUSION: The triple nucleoside combination Combivir/Abacavir was shown to be a potent and safe first line ART in HIV-1 infected adults with a comparable efficacy to a PI containing regimen at 24 weeks

Keywords: AEGIS, Dideoxynucleosides, Zidovudine, Lamivudine, Drug Combinations, CD4 Lymphocyte Count, HIV-1, Nelfinavir, Protease Inhibitors, HIV Protease Inhibitors, Antiretroviral Therapy, Highly Active, Drug Therapy, Combination, abacavir, Combivir, Human, Female, Male, Adult, therapy, drug therapy
000709
WeOrB605