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

CONTINUED INDINAVIR (800 MG TID) VERSUS SWITCHING TO INDINAVIR + RITONAVIR (800/100 MG BID) IN HIV PATIENTS HAVING ACHIEVED VIRAL LOAD SUPPRESSION. A RANDOMIZED STUDY: THE BID EFFICACY AND SAFETY TRIAL (BEST)

D. Podzamczer¹, J. Arrizabalaga², P. Van Wanzeele³, M. Harris⁴, C. Pedersen⁵, P. Cahn⁶, A. Casiro⁷, F. Chiodo⁸, J.A. Arnaiz⁹ and J.M. Gatell⁹ for the BEST Study Team
¹Hospital de Bellvitge, L’ Hospitalet, Spain; ²Hospital Aranzazu, San Sebastián, Spain; ³University Hospital, Gent, Belgium; ⁴St Paul’s Hospital, Vancouver, Canada; ⁵Odense University Hospital, Odense, Denmark; ⁶Fundación Huésped, Buenos Aires, Argentina; ⁷Hospital Álvarez, Buenos Aires, Argentina; ⁸Ospedale S. Orsola, Bologna, Italy; ⁹Hospital Clínic, Barcelona, Spain

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.7
AIDS 2000, Oct 22-26;14(Suppl. 4);S8

BACKGROUND: Triple therapy with indinavir (IDV) containing regimens achieve long term suppression of viral replication, immunological reconstitution, delay clinical progression and reduce mortality. Twice-a-day antiretroviral regimens including IDV plus low dose ritonavir (RTV) may offer some advantages: avoidance of both food restrictions and lunch time dose and a subsequent better adherence.

OBJECTIVE: The BEST is a randomized study aimed to test whether switching to bid administration of IDV 800 mg with RTV 100 mg is equivalent, in terms of antiviral activity and tolerability, to continued tid IDV therapy.

METHODS: Randomized, open-label, multicenter, clinical trial, in 326 stable HIV-infected patients on IDV-containing triple therapy with HIV-1 RNA levels below 500 copies/ml randomly assigned to either (a) continue on tid IDV or (b) switch to bid IDV 800 mg + RTV 100 mg plus same two nucleosides.

RESULTS: By the end of June 2000, 237 of the 326 patients enrolled had already completed a follow-up of at least 6 months. Baseline characteristics of both groups were similar. The proportions of patients with plasma HIV-1 RNA below 500 copies/ml at 6 months, and their 95% CI are shown in Table PL6.6:

More patients discontinued the assigned therapy because of adverse events in the bid arm than in the tid arm (19% versus 7%) mostly due to taste disturbances or gastrointestinal intolerance to the liquid formulation of RTV. Nephrolithiasis developed in 5% in the tid arm versus 12% in the bid arm leading to treatment discontinuation in 2% versus 3% respectively. Efficacy data using ultrasensitive viral load (HIV-1 RNA below 20 copies/ml) will be provided.

CONCLUSIONS: These preliminary data suggest that bid administration of IDV 800 mg in combination with RTV 100 mg is generally well tolerated and maintains comparable viral suppression in stable HIV-infected patients in comparison with the standard tid regimen.

Presenting author: J.M. Gatell

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2000-10-22
PL6-7

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