Abstract
Purpose: 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. Conclusion: 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.
Original language | English (US) |
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Pages (from-to) | 375-384 |
Number of pages | 10 |
Journal | HIV Clinical Trials |
Volume | 10 |
Issue number | 6 |
DOIs | |
State | Published - Jan 1 2009 |
Keywords
- Adherence
- Efavirenz
- HIV-1
- Quality of life
ASJC Scopus subject areas
- Infectious Diseases
- Pharmacology (medical)