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Short-term safety and tolerability of a once-daily fixed-dose abacavir-lamivudine combination versus twice-daily dosing of abacavir and lamivudine as separate components: findings from the ALOHA study.
- Source :
-
Pharmacotherapy [Pharmacotherapy] 2008 Mar; Vol. 28 (3), pp. 314-22. - Publication Year :
- 2008
-
Abstract
- Study Objective: To evaluate the short-term (12 wks) safety and tolerability of a once-daily, fixed-dose abacavir-lamivudine combination versus twice-daily dosing of the separate components, both with background antiretroviral therapy.<br />Design: Phase IIIB, randomized, open-label, parallel-group, multicenter study.<br />Setting: One hundred forty-six human immunodeficiency virus (HIV) clinics.<br />Patients: Six hundred eighty antiretroviral therapy-naïve patients with HIV type 1 RNA greater than 1000 copies/ml at baseline.<br />Intervention: Patients were randomly assigned in a 2:1 manner to receive either abacavir 600 mg-lamivudine 300 mg once/day or abacavir 300 mg twice/day and lamivudine 150 mg twice/day. Subjects were stratified based on choice of third or fourth antiretroviral drug (nucleoside reverse transcriptase inhibitor [NRTI], NNRTI, or protease inhibitor), assigned before randomization.<br />Measurements and Main Results: The primary end point was occurrence of grades 2-4 adverse events and serious adverse events; abacavir hypersensitivity reactions were considered serious adverse events. Baseline characteristics were similar between the once-daily (455 patients) and twice-daily (225 patients) groups. The rates of all grades 2-4 adverse events were similar: once-daily 33% (150 patients), twice-daily 31% (69). A slightly larger proportion of patients in the twice-daily group experienced drug-related grades 2-4 adverse events: once-daily 10% (47), twice-daily 16% (36). Rates of all serious adverse events (once-daily 11% [49], twice-daily 10% [22]) and drug-related serious adverse events (once-daily 5% [21], twice-daily 8% [17]) were similar. The rate of suspected abacavir hypersensitivity reaction was 5.3% (once-daily 4.4% [20], twice-daily 7.1% [16]), with a higher rate for the NNRTI stratum of the twice-daily group (8.6% [10]) than in any other stratum (once-daily, NNRTI 4.3% [10]; twice-daily, protease inhibitor 5.6% [6]; once-daily, protease inhibitor 4.6% [10]).<br />Conclusion: In the short-term, the rates of adverse events in the once-daily and twice-daily groups appeared to be similar. The rate of suspected abacavir hypersensitivity reaction in the once-daily group was lower than the rate in the twice-daily group.
- Subjects :
- Adult
Aged
Anti-HIV Agents therapeutic use
CD4 Lymphocyte Count
Dideoxynucleosides
Drug Administration Schedule
Drug Combinations
Female
Humans
Lamivudine therapeutic use
Male
Middle Aged
Patient Compliance
Patient Satisfaction
Viral Load
Anti-HIV Agents adverse effects
HIV Infections drug therapy
Lamivudine adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 0277-0008
- Volume :
- 28
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Pharmacotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 18294111
- Full Text :
- https://doi.org/10.1592/phco.28.3.314