Fifth International Congress Drug Therapy in HIV Infection 22-26 October, 2000 Glasgow, UK

ABT-378/RITONAVIR (ABT-378/r) VERSUS NELFINAVIR IN ANTIRETROVIRAL NAÏVE SUBJECTS: WEEK 48 COMPARISON IN A PHASE III BLINDED RANDOMIZED CLINICAL TRIAL

M. Johnson¹, G. Beall², A. Badley³, W. Cameron³, D. Johnson⁴, P. Ruane⁵, R. Rubio⁶, R. Stryker⁷, S. Walmsley⁸, M. King⁹, P. Cernohous⁹, J. Moseley⁹, M. Opferman⁹, M. Sattler⁹, B. Bernstein⁹, and E. Sun⁹ for the M98–863 Study Team
¹The Royal Free Hosp. London, UK; ²Res; And Ed., Torrance, California; ³Ottawa Gen. Hosp, Ottawa, Canada; ⁴Bedford Gardens, South Africa; ⁶Tower Infectious Diseases, Los Angeles, USA; ⁷Hosp. Doce de Octubre, Madrid, Spain; ⁸Pacific Oaks Res, Beverly Hills, California; USA; Toronto Gen. Hosp., Toronto, Canada; ⁹Abbott Laboratories, Abbott Park, Illinois, USA

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.5
AIDS 2000, Oct 22-26;14(Suppl. 4);S7

ABT-378/r is a novel protease inhibitor (PI) that achieves trough concentrations > 75-fold above the EC₅₀ of ABT-378 relative to wild type virus when dosed at 400/100 mg bid. A phase II study of ABT-378/r demonstrated activity in ARV-naïve subjects, 96% had VL < 400 copies/ml at Week 96 (OT) with 2/100 discontinuing for study drug-related AEs.

Study M98–863 is a multi-center, international, double-blind randomized study of 653 (129 female) ARV-naïve subjects treated with either ABT-378/r 400/100 mg bid (n = 326) or NFV 750 mg tid (n = 327). All subjects also received d4T and 3TC at standard doses. There were no significant differences between the two treatment groups in baseline HIV RNA (overall mean 4.9 log₁₀ copies/ml) and CD4 cell count (overall mean 259 cells/µl).

Genotypic and phenotypic analyses were performed on subjects with incomplete virologic suppression at Week 24. Of samples analyzed to date, 0/18 ABT-378/r subjects and 14/35 NFV subjects demonstrated evidence of phenotypic or genotypic resistance to the PI.

AEs occurring in > 2% of subjects included diarrhea, nausea, asthenia, abdominal pain, vomiting, and headache. The incidence rates of these events were similar between the two treatment groups. The most common laboratory abnormalities were triglyceride and cholesterol elevations. Through Week 40, 2% and 3% of subjects in the ABT-378/r and NFV groups, respectively, had discontinued due to PI-related AEs.

A significantly greater proportion of ABT-378/r treated subjects achieved HIV RNA below the LOQ in all analyses at Weeks 40 and 48. Both regimens were well tolerated, as manifested by the low incidence of study drug-related discontinuations through week 40.

Presenting author: M. Johnson

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2000-10-22
PL6-5

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