Effectiveness and Safety of a Single-tablet Regimen of Antiretroviral Drugs Containing Dolutegravir (DTG), Lamivudine (3TC) and Tenofovir Disoproxil fumarate (TDF) in Adult Patients with HIV Infection and AIDS at Srinagarind Hospital: A Retrospective Cohort Study
Keywords:
effectiveness, adverse drug reaction monitoring, adult patients with HIV infection and AIDS, antiretroviral drugs containing dolutegravir, lamivudine and tenofovir disoproxil fumarateAbstract
Background and Objectives: According to the “Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2021/2022”, a first-line recommended a single-tablet regimen of antiretroviral drugs containing dolutegravir (DTG), lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a single tablet. However, there is limited data on the efficacy and safety of single-tablet antiretroviral regimens. This study aimed to evaluate the effectiveness and safety of a single-tablet regimen of antiretroviral drugs to be a guidance of following up and maintenance of adult HIV- infect patients’ treatments.
Methods: A retrospective cohort study was conducted among HIV-infected patients receiving single-tablet antiretroviral therapy at the Adult Infectious Diseases and AIDS Clinic, Srinagarind Hospital, from October 1, 2023 to March 31, 2024. Data collection was divided into two parts: Part 1 was about general informations, disease-related details, and health behaviors gathered by self-administered questionnaires. Part 2 consisted of monitoring medication use, treatment efficacy evaluation, and drug safety using medical records and the hospital’s electronic database. Descriptive statistics were used for data analysis.
Results: A total of 292 patients participated in the study. The majority was male (61.3%). The mean age was 43.98 ± 12.75 years, and the average duration of a single tablet regimen antiretroviral therapy (DTG, 3TC and TDF) use was 15.0 ± 6.97 months. In terms of treatment efficacy, 272 patients (93.2%) had an undetectable HIV viral load in the bloodstream after at least six months of treatment, cluster of differentiation 4 (CD4) counts significantly increased from 517.0 ± 261.7 cells/mm3 to 601.7 ± 256.6 cells/mm3 (p < 0.001). Average viral load (VL), VL also significantly decreased (p < 0.001). Regarding safety, there were 37 patients (12.7%) who reported adverse effects, most of the symptoms were mild such as headaches, fatigue, weakness, and nausea/vomiting. Laboratory findings showed an increasing in serum creatinine (Scr) from 0.89 ± 0.17 mg/dL to 1.02 ± 0.20 mg/dL along with a decreasing in estimated glomerular filtration rate (eGFR) from 96.22 ± 15.82 mL/min/1.73m² to 82.51 ± 15.60 mL/min/1.73m². Moreover, 76.5% of patients experienced a rising of both body weight and body mass index (BMI).
Conclusion: The single-tablet antiretroviral regimen including TDF, 3TC, and DTG has demonstrated good efficacy in HIV treatment by showing effective control in viral replication with minimal side effects. However, the safety profile on renal function remains a limitation, further investigation is still needed in future studies.
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