Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine

12Citations
Citations of this article
44Readers
Mendeley users who have this article in their library.

Abstract

Background The side-effects of anti-retroviral drugs are different between Japanese and Caucasian patients. Severe central nerve system (CNS) side-effects to efavirenz and low rate of hypersensitivity against abacavir characterize the Japanese. Objective The objective of this study was to select a once daily regimen for further non-inferior study comparing the virological efficacy and safety of the first line once daily antiretroviral treatment regimens in the current HIV/AIDS guideline. Methods The study design was a randomized, open label, multicenter, selection study. One arm was treated with efavirenz and the other with ritonavir-boosted atazanavir. A fixed-dose lamivudine plus abacavir were used in both arms. The primary endpoint was virologic success (viral load less than 50 copies/mL) rate at 48 weeks. Patients were followed-up to 96 weeks with safety as the secondary endpoint. Clinicaltrials.Gov (NCT 00280969) and the University hospital Medical Information Network (UMIN000000243). Results A total of 71 participants were enrolled. Virologic success rates in both arms were similar at week 48 [efavirenz arm 28/36 (77.8%); atazanavir arm 27/35 (77.1%)], but were decreased at week 96 to 55.6% in the efavirenz arm and 68.8% in the atazanavir arm (p=0.33). At the 96-week follow-up, 52.8% of the EFV arm and 34.3% of the ATV/r arm reached total cholesterol more than 220 mg/dL and required treatment. None of the patients developed cardiovascular complications in this study by week 96. Conclusion There was no significant difference in the efficacy of efavirenz and ritonavir-boosted atazanavir combined with lamivudine plus abacavir at 48 weeks. The evaluation of safety was extended to 96 weeks, which also showed no significant difference in both arms. © 2011 The Japanese Society of Internal Medicine.

References Powered by Scopus

Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir

1300Citations
N/AReaders
Get full text

Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: A multi-cohort collaboration

812Citations
N/AReaders
Get full text

Changes in mitochondrial DNA as a marker of nucleoside toxicity in HIV-infected patients

527Citations
N/AReaders
Get full text

Cited by Powered by Scopus

Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials

296Citations
N/AReaders
Get full text

Comparative efficacy and safety of first-line antiretroviral therapy for the treatment of HIV infection: a systematic review and network meta-analysis

162Citations
N/AReaders
Get full text

Comparative safety and neuropsychiatric adverse events associated with efavirenz use in first-line antiretroviral therapy: A systematic review and meta-analysis of randomized trials

56Citations
N/AReaders
Get full text

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Cite

CITATION STYLE

APA

Honda, M., Ishisaka, M., Ishizuka, N., Kimura, S., & Oka, S. (2011). Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Internal Medicine, 50(7), 699–705. https://doi.org/10.2169/internalmedicine.50.4572

Readers' Seniority

Tooltip

PhD / Post grad / Masters / Doc 15

56%

Researcher 11

41%

Professor / Associate Prof. 1

4%

Readers' Discipline

Tooltip

Medicine and Dentistry 18

58%

Pharmacology, Toxicology and Pharmaceut... 8

26%

Nursing and Health Professions 3

10%

Biochemistry, Genetics and Molecular Bi... 2

6%

Save time finding and organizing research with Mendeley

Sign up for free