PMID- 16280696
OWN - NLM
STAT- MEDLINE
DCOM- 20060110
LR  - 20200930
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 40
IP  - 4
DP  - 2005 Dec 1
TI  - 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).
PG  - 422-7
AB  - 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.
FAU - Sosa, Nestor
AU  - Sosa N
AD  - Social Security Hospital, Panama City, Panama.
FAU - Hill-Zabala, Christina
AU  - Hill-Zabala C
FAU - Dejesus, Edwin
AU  - Dejesus E
FAU - Herrera, Gisella
AU  - Herrera G
FAU - Florance, Allison
AU  - Florance A
FAU - Watson, Maria
AU  - Watson M
FAU - Vavro, Cindy
AU  - Vavro C
FAU - Shaefer, Mark
AU  - Shaefer M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Dideoxynucleosides)
RN  - 0 (Drug Combinations)
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (RNA, Viral)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - 2T8Q726O95 (Lamivudine)
RN  - WR2TIP26VS (abacavir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-HIV Agents/*administration & dosage/adverse effects/therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Dideoxynucleosides/*administration & dosage/adverse effects/therapeutic use
MH  - Drug Combinations
MH  - Drug Resistance, Viral
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - HIV Protease Inhibitors/administration & dosage/pharmacology
MH  - Humans
MH  - Lamivudine/*administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - RNA, Viral/blood
MH  - Reverse Transcriptase Inhibitors/administration & dosage/pharmacology
MH  - Treatment Outcome
MH  - Treatment Refusal
MH  - Viral Load
EDAT- 2005/11/11 09:00
MHDA- 2006/01/13 09:00
CRDT- 2005/11/11 09:00
PHST- 2005/11/11 09:00 [pubmed]
PHST- 2006/01/13 09:00 [medline]
PHST- 2005/11/11 09:00 [entrez]
AID - 00126334-200512010-00006 [pii]
AID - 10.1097/01.qai.0000184859.24071.bd [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):422-7. doi: 
      10.1097/01.qai.0000184859.24071.bd.