Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). Journal of acquired immune deficiency syndromes (1999) [J Acquir Immune Defic Syndr] Journal article | | Title | Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). | | Author(s) | Sosa N, Hill-Zabala C, Dejesus E, Herrera G, Florance A, Watson M, Vavro C, Shaefer M | | Institution | Social Security Hospital, Panama City, Panama. | | Source | J Acquir Immune Defic Syndr 2005 Dec 1; 40(4):422-7. | | MeSH | Adult
Aged
Anti-HIV Agents
CD4 Lymphocyte Count
Comparative Study
Dideoxynucleosides
Drug Combinations
Drug Resistance, Viral
Drug Therapy, Combination
Female
HIV Infections
HIV Protease Inhibitors
Humans
Lamivudine
Male
Middle Aged
RNA, Viral
Research Support, Non-U.S. Gov't
Reverse Transcriptase Inhibitors
Treatment Outcome
Treatment Refusal
Viral Load
| | Abstract | BACKGROUND: Abacavir (ABC) and lamivudine (3TC) administered twice daily were compared with an ABC + 3TC fixed-dose combination (Epzicom, Kivexa; EPZ) administered once daily, both in combination with a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).
METHODS: Two hundred sixty HIV-infected subjects with more than 6 months of ABC and 3TC administered twice daily plus a PI or NNRTI with an HIV-1 RNA level less than 400 copies/mL for more than 3 months and a CD4 count greater than 50 cells/mm were randomized 1:1 to ABC + 3TC administered twice daily or EPZ administered once daily.
RESULTS: At baseline, median time on ABC and 3TC administered twice daily was 22 months, and median CD4 count and HIV-1 RNA level were 554 cells/mm and <50 copies/mL, respectively. EPZ administered once daily was established as not inferior to ABC + 3TC administered twice daily based on the proportion of nonvirologic failures (confirmed HIV-1 RNA level > or =1265 copies/mL; 90% confidence interval: -3.4 to 6.4; (intent to treat [ITT]: missing [M] = failure [F]). Proportions with an HIV-1 RNA level <50 copies/mL were 81% of those taking EPZ once daily and 82% of those taking ABC + 3TC twice daily at week 48 (ITT: M = F). Virologic failure was rare (2 patients taking the once-daily regimen, 4 patients taking the twice-daily regimen). There was a low incidence of grade 2 through 4 adverse events (AEs) and no drug-related serious AEs or hypersensitivity reactions.
CONCLUSIONS: EPZ administered once daily was established as not inferior to ABC + 3TC administered twice daily in a regimen containing an NNRTI or a PI over 48 weeks. A dual-nucleoside backbone of ABC and 3TC administered once or twice daily is effective, durable, and well tolerated. | | Language | eng | | Pub Type(s) | Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 16280696 |
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