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

Abstract

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.

Which antiretroviral regimen is associated with higher adherence in Brazil? A comparison of single, multi, and dolutegravir-based regimens

“…The overall prevalence of adherence observed in the present study was similar to the ones reported in Brazil in earlier years 21,22 and worldwide 23,24,25 . Previous studies using the MMAS-8 with the same cut-off point as ours reported a prevalence of adherence of 43.7% 24 and 61.7% 25 , while studies using other self-report measurements of adherence reported rates above 70% 3,26,27 .…”

“…However, this method is fast, easy to apply and is a good predictor of virological failure 44 . Furthermore, several studies used the MMAS-8 to measure HAART adherence 23,24,25,35 and although there is a multiplicity of indirect measures of adherence, none of them is considered a "gold standard". The triangulation of methods increases the validity and reliability of the adherence results.…”

Interventions on Improving Medication Adherence in Malaysia: A Mini Review

“…A total of 66% of the studies employed prospective RCT design with some further elaborating the type of randomization, such as block stratified randomization and blinding strategy. Generally, those studies which employ prospective randomized control trial, [12][13][14][16][17][18][19][20]22 multicentered, 20,23 longer period of intervention evaluation with equal or more than 6 months 13,18,19,21,22 and having blinding approach 20 are better approaches to evaluate the effectiveness of an intervention. 26 Two studies which use retrospective approach 15,21 would create selection bias due to lacking randomization, where the significant difference between intervention and control groups is confounded with pre-existing differences between both groups.…”

“…It is found that eight out of nine prospective randomized controlled studies are considered low-quality studies. [12][13][14][16][17][18][19][20]22 Such findings on the methodological quality could be arguably over-stringent as Zwikker et al also reported that all 30 included studies under review were judged as lowquality study with the use of the same judging framework. 27 On the other hand, the framework undeniably provides a clear guideline on designing a study with high quality methodology.…”

“…Subsequently, 12 articles were retained for further evaluation. [12][13][14][15][16][17][18][19][20][21][22][23] The summary of these articles which are related to the interventions on improving medication adherence in Malaysia are tabulated as shown in Supplementary Material 1. To evaluate the methodological quality of the included studies, the framework of judging methodological quality used by Zwikker et al originated from Hayden et al is adopted.…”