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ORIGINAL RESEARCH

Drug Use Evaluation of Tenofovir/Lamivudine/Dolutegravir (TLD) Fixed-Dose Combination for Initiation and Transition Among HIV-Infected Individuals Attending Lumame Primary Hospital, North West Ethiopia

ORCID Icon, ORCID Icon &
Pages 31-42 | Received 25 Jan 2024, Accepted 12 Apr 2024, Published online: 17 Apr 2024
 

Abstract

Background

A key strategy for quality improvement is drug use evaluation, which looks at the safe, appropriate use of medication principles. Tenofovir/Lamivudine/Dolutegravir (TLD-FDC) usage has not yet been sufficiently examined in published literature. The purpose of this study was to assess how TLD were used by HIV-positive patients Using WHO drug use evaluation standards in Lumame Primary Hospital, North West Ethiopia.

Methods

Using WHO drug use evaluation standards, a retrospective study design was used to evaluate the appropriateness of TLD use. Systematic random sampling was utilized to gather patient medical records containing TLD. Accordingly, 100 records that met the inclusion criteria were selected and reviewed between April 1 and 15, 2021. Five criteria, namely, indication, dose, contraindication, drug interaction, and TLD safety monitoring were used to evaluate the appropriateness of TLD utilization.

Results

80% of patients were transited to TLD from other regimens. The median time on TLD was found to be 13 months with 9 months to 18 months IQR. The latest CD4 count as well as CD4 count at the initiation or transition of TLD was not done for 75% and 89% of the patients, respectively. 3/4 (75%) of the patients were found to have a scheduled medication refill history. TLD dosing, indications, and contraindications were found to be 100% appropriate. No, TLD safety monitoring tests were done for 21% of the patients in this study. However, viral load, liver/kidney function, and serum creatinine tests were done for 77% (95% CI: 74%–79%), 5% (95% CI: 2%–8%), and 14% (95% CI: 11%–17%) of the patients, respectively. More over, In 93% (95% CI: 91%–95%) of the patients, the TLD interaction was appropriate; in 7%, it was not. All recording, documenting, and reporting technologies were available and used efficiently, except for the Electronic Dispensing Tool.

Conclusion

Generally, good adherence to national and WHO guidelines was obtained regarding dose, indication, and contraindications. However, improvement in safety monitoring tests and CPT utilization is recommended. Drug interactions satisfied the majority of the criteria’s threshold, while certain standards were not followed.

Abbreviations

AIDS, Acquire immunodeficiency syndrome; ART, Antiretroviral therapy; ARV, Antiretroviral; ASM, Appointment Spacing Model; DTG, Dolutegravir; DTC, Drug and Therapeutic Committee; DUE, Drug Use Evaluation; EDT, Electronic Dispensing Tool; EFV, Efaverenz; FDC, Fixed Dose Combination; HAART, Highly Active Anti-Retroviral Therapy; HIV, Human immunodeficiency virus; INSTI, Integrase Strand Transfer Inhibitors; JCAHCO, Joint Commission on Accreditation of Healthcare Organizations; 3TC, Lamivudine; NNRTI, Non-Nucleoside Reverse Transcriptase Inhibitors; Nucleoside (and Nucleotide) Reverse Transcriptase Inhibitors; PCP, Pneumocystis carinii pneumonia; PI, Protease Inhibitors; TDF, Tenofovir Disoproxil Fumarate; TLD, Tenofovir + Lamivudine + Dolutegravir; TLE, Tenofovir + Lamivudine + Efaverenz; WHO, World Health Organization.

Data Sharing Statement

The manuscript contained all the required information.

Ethics Approval and Consent to Participate

The ethical committee at Lumame Hospital granted ethical clearance and approval for this study, which was carried out per the Declaration of Helsinki’s ethical standards. The study’s reference number is LPH/242/2021. The need for informed consent was waived by the Lumame Hospital ethics committee, and the privacy and confidentiality of all patients’ medical records data were properly secured at all times. Since there are currently no published studies assessing ART medications like the TLD FDC in Ethiopia.

Acknowledgments

We appreciate Lumame Hospital allowing us to perform the research on drug usage evaluation. We want to express our sincere appreciation to Global Health Supply Chain -Procurement and Supply Management for their technical assistance with the creation of this research. We are grateful for data gatherers as well.

Disclosure

The authors declared that there are no competing interests in this work.