20915
document
Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults : results of the Ziagen Once Daily in Antiretroviral Combination Study . The long intracellular half-life of abacavir ( ABC ) supports its once-daily use , and this would be expected to simplify treatment if ABC could be given as part of a complete once-daily regimen . A randomized double-blind clinical trial compared the efficacy and safety of 600 mg of ABC administered once daily ( n = 384 ) versus 300 mg of ABC administered twice daily ( n = 386 ) in combination with 300 mg of lamivudine ( 3TC ) and 600 mg of efavirenz ( EFV ) administered once daily in antiretroviral-naive patients over 48 weeks . The baseline median plasma HIV-1 RNA level was 4.89 log10 copies/mL ( 44 % with viral load > 100,000 copies/mL ) , and the median CD4 cell count was 262 cells/mm . ABC administered once daily was non-inferior to the twice-daily regimen , with 66 % and 68 % of patients in these respective treatment arms achieving a confirmed plasma HIV-1 RNA level < 50 copies/mL ( 95 % confidence interval : -8.4 % , 4.9 % ) . The ABC once-daily and twice-daily regimens were similar with respect to infrequency of virologic failure ( 10 % vs. 8 % ) , emergence of resistance mutations , CD4 cell increases from baseline ( median , 188 vs. 200 cells/mm ) , safety profile , and incidence of ABC-related hypersensitivity reactions ( 9 % vs. 7 % ) . ABC administered once daily in combination with 3TC and EFV administered once daily was non-inferior to the ABC twice-daily dosing schedule when combined with 3TC and EFV over 48 weeks .
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Intervention_Pharmacological
Abacavir
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Intervention_Pharmacological
lamivudine and efavirenz
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Intervention_Pharmacological
Ziagen
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Intervention_Pharmacological
abacavir ( ABC )
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
lamivudine ( 3TC )
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Intervention_Pharmacological
efavirenz ( EFV )
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
ABC-related
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
3TC
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Intervention_Pharmacological
EFV
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Intervention_Pharmacological
ABC
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Intervention_Pharmacological
3TC
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Intervention_Pharmacological
EFV
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Outcome_Physical
antiretroviral-naive
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
baseline median plasma HIV-1 RNA level
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Outcome_Physical
plasma HIV-1 RNA level
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Outcome_Physical
infrequency of virologic failure
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Outcome_Physical
emergence of resistance mutations , CD4 cell increases from baseline
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Outcome_Physical
safety profile
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Outcome_Physical
incidence of ABC-related hypersensitivity reactions
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Participant_Condition
antiretroviral-naive HIV-infected
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Participant_Age
adults
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Participant_Condition
antiretroviral-naive