Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan
Efavirenz (EFV) is the most widely used non-nucleoside reverse transcriptase inhibitor (NNRTI). The recommended dose of EFV is 600 mg daily; however, a phase II study showed no significant difference in viral suppression rates across the different EFV groups (200 mg, 400 mg, and 600 mg) at 24 weeks. The week 96 analysis of ENCORE 1 study confirmed the durable virological non-inferiority of EFV 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Fewer EFV-related adverse events (AEs) and fewer treatment discontinuations were also observed in the reduced dose group. The efficacy and safety findings provide robust evidence to redefine the EFV dose for HIV treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.
E-Da Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
C12 EFV concentration
The proportion of subjects achieving C12 EFV concentration \>1.0 mg/L at Week 4.
Time frame: Week 4
HIV-1 RNA load
The proportion of subjects with undetectable plasma HIV-1 RNA load (\<50 copies/mL) at Week 12
Time frame: Week 12
HIV-1 RNA load
The proportion of subjects with undetectable plasma HIV-1 RNA load (\<50 copies/mL) at Week 24
Time frame: Week 24
EFV concentration
The mean changes from baseline in C12 EFV concentration at Week 4.
Time frame: Week 4
CD4+ T cell count
The mean changes from baseline in CD4+ T cell count at Week 12.
Time frame: Week 12
CD4+ T cell count
The mean changes from baseline in CD4+ T cell count at Week 24.
Time frame: Week 24
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