Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naïve HIV-1-infected patients over 96 weeks.
OBJECTIVE
This study evaluated the long-term efficacy, safety, adherence, and quality of life (QoL) of a once-daily efavirenz-based antiretroviral regimen in two 96-week prospective open-label single-arm studies of treatment-naïve HIV-1-infected patients.


METHODS
Patients received once-daily efavirenz 600 mg and lamivudine 300 mg with either enteric-coated didanosine 400 mg (Daily Antiretroviral Therapy trial [DART] I) or extended-release stavudine 100 mg (DART II). The primary efficacy outcome measure was HIV RNA <400 copies/mL at Week 48.


RESULTS
In an intent-to-treat (ITT) analysis, HIV RNA level <400 (<50) copies/mL was reached by 82%(80%) and 74% (72%) of patients at Week 48 in DART I and II. At Week 96, the corresponding values were 74% (68%) and 55% (54%), respectively. Both regimens were well tolerated. There were no discontinuations for virologic failure. Medication adherence assessed by pill counts was above 80% in 90% of the patients in DART I and more than 80% of patients in DART II. Treatment produced a significant improvement in overall QoL.


CONCLUSIONS
Once-daily efavirenz-based antiretroviral therapy was effective, durable, and well tolerated. In this study, a high level of adherence was achieved with improvement in overall QoL.
Miller School of Medicine, University of Miami, Miami, FL 33136, USA. djayawee@med.miami.edu
Dushyantha
D
Jayaweera
Edwin
E
Dejesus
Kim L
KL
Nguyen
Kristy
K
Grimm
David
D
Butcher
Daniel W
DW
Seekins
D000328:Adult; D000368:Aged; D000480:Alkynes; D048588:Benzoxazines / Q000008:administration & dosage* / Q000009:adverse effects; D003521:Cyclopropanes; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood / Q000187:drug effects; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D018119:Stavudine / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D018119:Stavudine; C098320:efavirenz; D016049:Didanosine