96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures.

Authors

Johnson M, Grinsztejn B, Rodriguez C, et al. 

Institution

Royal Free Hospital, London, UK. margaret.johnson@royalfree.nhs.uk

Source

AIDS 2006 Mar 21; 20(5) :711-8.

Abstract

BACKGROUND
In BMS Study 045, once-daily (QD) atazanavir/ritonavir (ATV/RTV) demonstrated comparable efficacy and safety to twice-daily (BID) lopinavir/ritonavir (LPV/RTV) over 48 weeks in treatment-experienced patients. Results of extended follow-up to 96 weeks are presented.
METHODS
BMS Study 045 was an open-label, randomized, multi-national trial of HIV-infected patients with virologic failure on two or more prior HAART regimens designed to evaluate the efficacy and safety of ATV/RTV (300/100 mg) QD and LPV/RTV (400/100 mg) BID, each with tenofovir (300 mg) QD and one nucleoside reverse transcriptase inhibitor. The primary efficacy measure was the time-averaged difference (TAD) in reduction in HIV RNA from baseline. Secondary objectives included evaluation of safety and plasma lipid levels through week 96.
RESULTS
Over 96 weeks, the ATV/RTV regimen demonstrated similar virologic efficacy to the LPV/RTV regimen. Mean reductions from baseline in HIV RNA were -2.29 and -2.08 log10 copies/ml, respectively [TAD (97.5% confidence interval): 0.14 log10 copies/ml (-0.13, 0.41)]. The LPV/RTV regimen resulted in significant increases in total cholesterol (+9%) and fasting triglycerides (+30%) in comparison with the ATV/RTV regimen, which demonstrated decreases in these parameters [-7 and -2%, respectively, (P < 0.0001)]. Grade 2-4 diarrhoea occurred less frequently in ATV/RTV patients (3%) in comparison with LPV/RTV patients (13%) (P < 0.01). Grade 3-4 elevations in bilirubin were more common in ATV/RTV patients (53%) than LPV/RTV patients (< 1%) (P < 0.0001), with no resulting discontinuations.
CONCLUSIONS
Regimens containing once-daily ATV/RTV demonstrated comparable efficacy and safety, with significant reductions in total cholesterol and fasting triglycerides and improved gastrointestinal-tolerability in comparison with twice-daily regimens containing LPV/RTV over 96 weeks in treatment-experienced patients.

Mesh

Adenine
Adult
Anti-HIV Agents
Antiretroviral Therapy, Highly Active
Didanosine
Drug Administration Schedule
Drug Therapy, Combination
Female
HIV Infections
HIV-1
Humans
Lipids
Male
Oligopeptides
Phosphonic Acids
Pyridines
Pyrimidinones
RNA, Viral
Ritonavir
Saquinavir
Time Factors
Treatment Outcome

Language

eng

Pub Type(s)

Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

PubMed ID

16514301