AEGiS-13IAC: Antiviral potency and tolerability of a convenient 2-drug regimen, ritonavir (RIT) and indinavir (IDV) in antiretroviral-naive, inner-city minority patients with advanced AIDS and/or high viral loads.

13th International AIDS Conference

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

Antiviral potency and tolerability of a convenient 2-drug regimen, ritonavir (RIT) and indinavir (IDV) in antiretroviral-naive, inner-city minority patients with advanced AIDS and/or high viral loads.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. TuOrB299)

Jayaweera D, Scerpella E, Lalanne R, Asthana D, Kolber M
D. Jayaweera, University of Miami School of Medicine, 901, NW 17th Street, Suite D (D90A), Park Plaza East, Miami FL 33136, United States, Tel.: +1 305 243 4598, Fax: +1 305 243 4037, E-mail: djayawee@med.miami.edu

BACKGROUND: Inner-city minority patients with substance abuse have multiple problems that contribute to poor adherence to antiretrovirals. Simple and tolerable but potent regimens may help to improve adherence and outcomes. We evaluated a 2-drug regimen of RIT+IDV (without NRTIs/NNRTIs) in patients with advanced disease and/or high viral loads (VL).

METHODS: Prospective, nonrandomized, pilot-study in an inner-city, hospital-based clinic. Antiretroviral-naive patients were treated with RIT+IDV 400/400mg BID. Frequent visits to address adherence were planned (weeks 1, 2, 3, 4, 8, 12, 16, 24, 36, 48).

RESULTS: Nineteen patients were enrolled. Mean age 41.9 years, 58% were men, 18/19 (95%) belonged to minority groups, 79% had unprotected heterosexual contact as their HIV risk factor. Median CD4 was 101 cells /mm³ (47% had >50 cells). Mean HIV-1 viral load (VL) was 162,181 copies /mL (5.21 é 0.85 logs) at entry and decreased to 3.72 (wk 2), 3.32 (wk 4), 3.29 (wk 12), and 2.61 logs at week 24. Median CD4 count increased from 101 to 249 cells by week 24. Five patients discontinued treatment due to substance abuse (2), non-adherence (2), and side effects (1). Of the remaining patients, 11/14 (78%) have undetectable VL. Seven patients had adherence problems unrelated to side effects, which improved with counseling and close follow-up. On intention to treat analysis 58% (11/19) of the subjects reached undetectable VL.

CONCLUSIONS: This regimen of RIT+IDV shows a good antiviral potency and tolerability in this difficult-to-treat population. A larger controlled study should be undertaken.

Keywords: AEGIS, Ritonavir, Indinavir, Viral Load, CD4 Lymphocyte Count, HIV-1, Pharmaceutical Preparations, Pilot Projects, Human, Male
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TuOrB299