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Abstract
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)
CAHN P, CASIRÓ A, PUENTES T, DAVID D, RICHTER C, STEK M, GATELL J
Background: Triple therapy with indinavir (IDV) containing regimens achieve long term suppression of viral replication, immunological reconstitution, delay clinical progression and reduce mortality. A twice-a-day ritonavir (RTV) boosted IDV regimen may be more convenient by avoiding both food restrictions and lunch time dose and a subsequent better adherence. Objective: The BEST is a randomized study 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 assigned to either (a) continue on TID IDV or (b) switch to BID IDV 800 mg + RTV 100 mg maintaining the same 2 NRTIs. Results: By Jan 2001, 253 of the 326 patients enrolled had completed at least 12 months of follow-up. Both groups were similar at baseline. Proportions of patients with plasma HIV-1 RNA <500 cps/mL and <20 cps/mL at 12 mo, and their 95%CI are:
Arm Population % < 500 % < 20
TID IDV Intent-to treat 86 (80-91) 75 (60-86)
(n= 122) As-treated 95 (89-100) 76 (59-89)
BID IDV+RTV Intent-to treat 88 (82-93) 69 (56-80)
(n= 131) As-treated 96 (90-100) 66 (49-80)
More patients discontinued the assigned therapy because of adverse events in the BID arm than in the TID arm (29% vs 10%) mainly due to GI symptoms. Nephrolithiasis developed in 9% in the TID arm vs 21% in the BID arm leading to treatment discontinuation in 4% vs 7% respectively. Serum lipid elevations, but not lipodystrophy, were more frequent in the BID arm. Conclusion: BID administration of IDV 800 mg with RTV 100 mg is generally well tolerated and maintains viral suppression in stable HIV-infected patients in comparison with the standard TID regimen. Final data at 12 months will be presented.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
60
Suggested Citation
"CAHNP, et al.
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).
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
60"
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