Vernazza P, Katlama C, Clotet B, Plettenberg A, Goh L, Cutrell A, Purdon S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 139 (abstract no. 378).
Kantonsspital, St Gallen, Switzerland.
Objectives: To assess intensification of stable background ART with abacavir over 48 weeks in subjects with detectable plasma HIV-1 RNA (vRNA). Long term safety and tolerance will also be evaluated. Methods: 185 ART experienced adults; on stable background therapy (SBG) for > 12 weeks expecting continued benefit for > 16 weeks; plasma HIV-1 RNA > 400- < 50,000 c/mL; no prior history of CD4+ counts < 100 cells/mm3; were randomised to receive either ABC (300 mg BID) + SBG or ABC-placebo (BID) + SBG. Randomisation was stratified according to whether subjects were 3TC experienced or 3TC naIve and duration of prior NRTI therapy. Results: At Week 16, 32/92 (39%) of subjects in the ABC + SBG group had vRNA < 400 c/mL compared to 7/93 (8%) in the PBO + SBG group (ITT), p < 0.001. At week 16, a higher proportion of subjects who were 3TC-experienced had vRNA < 400 c/mL following addition of ABC than those who were 3TC-naive. At week 16, 46% of subjects in the ABC+SBG group demonstrated either a > 1 log10 reduction in vRNA or vRNA < 400 c/mL compared to 9% in the PBO+SBG group (ITT). ABC was well tolerated over a 16 week treatment period when administered to ART experienced subjects in addition to their SBG. There were few treatment limiting AEs. 48-week efficacy and safety data will be presented. Conclusion: Intensification of SBG with ABC in ART experienced subjects has demonstrated antiretroviral activity of ABC regardless of prior 3TC therapy. ABC can be used as an active component of multidrug combination therapy in ART experienced subjects.
Publication Types:
Keywords:
- Adult
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Dideoxynucleosides
- Drug Therapy, Combination
- Humans
- Lamivudine
- abacavir
- drug therapy
- therapy
Other ID:
UI: 102195147
From Meeting Abstracts