Simplification of HAART therapy on ambulatory HIV patients in Malaysia: a randomized controlled trial

• Main Authors: Velvanathan T (Author), Islahudin F (Author), Sim BL (Author), Taha NA (Author)
• Format: Book
• Published: Centro de Investigaciones y Publicaciones Farmaceuticas, 2016-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.18549/PharmPract.2016.04.830; 1885-642X; 1886-3655
• Keywords: Antiretroviral Therapy Highly Active; Emtricitabine; Tenofovir; Benzoxazines; Anti-Retroviral Agents; Drug Combinations; CD4 Lymphocyte Count; Viral Load; Malaysia; Therapeutics. Pharmacology; RM1-950; Pharmacy and materia medica; RS1-441
• Source: Pharmacy Practice, Vol 14, Iss 4, Pp 830-830 (2016)

Objective: Evaluate the impact of fixed-dose combination (FDC) containing emtricitabine (FTC), tenofovir (TDF), and efavirenz (EFV) versus a free-dose combination (FRC) of the same three drugs on clinical outcomes, adherence and quality of life in Malaysian outpatients with HIV. Methods: HIV patients (n=120) on highly active antiretroviral therapy (HAART) in the infectious disease clinic of Hospital Sungai Buloh were randomized to either FDC (n=60) or FRC (n=60). Morisky scores, health-related quality of life scores and clinical outcomes such as CD4 count and viral load were assessed in both groups at baseline and six months. Result: Patients on FDC (108 SD=1.1) had a significantly higher CD4 count increase compared to the FRC group (746.1 SD=36.3 vs 799.8 SD=33.8) (p <0.001). The viral load profile was unchanged and remained undetectable in both groups. The quality of life EQ-5D scores showed a positive correlation with CD4 counts in the FDC group (ρ=0.301, p=0.019) at six months. On the other hand, quality of life EQ-VAS scores was significantly associated with medication adherence in the FDC group at six months (ρ=0.749, p=0.05). However, no significant changes or associations were observed in the FRC group. Conclusion: Management of HAART using an FDC demonstrated a positive clinical outcome, adherence and quality of life within six months in local HIV patients.