Second-Line Antiretroviral Treatment Outcomes and Predictors in Tigray Region, Ethiopia

Abstract

Introduction

Ethiopia has one of the highest HIV burdens in sub-Saharan Africa. Despite the fact that second-line antiretroviral therapy (ART) has been available for more than ten years, studies on its effectiveness are scarce.

Objective

To assess treatment outcomes and predictors of unfavorable outcomes in HIV patients receiving second-line ART at Ayder Comprehensive Specialized Hospital and Mekelle Hospital.

Materials and Methods

An institution-based retrospective cohort study was conducted in two hospitals in Tigray Region, Ethiopia. We evaluated 192 patients aged ≥15 years who were switched to second-line from November 2009 to May 2020 after failure of first-line ART. The primary outcome was the time from the initiation of second-line ART to the occurrence of unfavorable treatment outcomes (treatment failure, death, and loss to follow-up). We performed Kaplan–Meier survival estimates to calculate the cumulative incidence rates of unfavorable outcomes.

Results

The mean age (SD) at the initiation of second-line ART was 39 (10.03) years, and the median CD4 cell count was 121 cells/microL. During a median follow-up of 4.6 years, 24 (12.5%) patients had died, 11 (5.7%) patients were lost to follow up, and 47 (24,4%) patients were experienced treatment failure. The incidence rates for unfavorable outcomes were 7.8 per 100 patients/years. Predictors for unfavorable outcomes were body mass index (BMI) <18.5 (adjusted hazard ratio [aHR] = 2.51, 95% confidence interval (CI): 1.27–4.95) and CD4 counts ≤100 cells/microL (aHR = 1.74, 95% CI: 1.09–2.79). Despite the failure of second-line ART, none of the patients received third-line ART.

Conclusion

The incidence rate of unfavorable treatment outcomes for second-line ART was found to be high. A low BMI and a low baseline CD4 count were significant predictors of unfavourable outcomes and should be given special consideration in HIV care. A third-line ART regimen should also be considered for people who have failed second-line ART.

Keywords:

• human immunodeficiency virus
• second-line ART
• outcomes

Abbreviations

3TC, Lamivudine; ACSH, Ayder Comprehensive Specialized Hospital; ABC, Abacavir; aHR, Adjusted hazard ratio; ART, Antiretroviral Therapy; ATV/r, Atazanavir/ritonavir; BMI, Body Mass Index; cHR, crude hazard ratio; CI, Confidence Interval; EFV, Efavirenz; HIV, Human Immunodeficiency Virus; LPV/r, Lopinavir/ritonavir; LTFU, Loss to follow-up; MH, Mekelle Hospital; NNRTI, Non-Nucleoside Reverse-Transcriptase Inhibitors; NRTI, Nucleoside Reverse Transcriptase Inhibitors; NVP, Nevirapine; PI, Protease inhibitors; TDF, Tenofovir; WHO, World Health Organization; ZDV, Zidovudine.

Data Sharing Statement

The dataset of this study is available from the corresponding author upon reasonable request.

Ethics Approval and Consent to Participate

Ethical approval was obtained from the Ethics Review Committee of the School of Pharmacy, College of Health Sciences, Mekelle University and the committee waived the need for informed consent as it was a retrospective study. The study was conducted in accordance with the Declaration of Helsinki. A letter of support was obtained from the hospital’s medical director to access the patient’s charts. Patient data were recorded using a personal identifier, and the privacy of personal information was strictly protected.

Acknowledgments

The authors would like to thank the College of Health Science, Mekelle University for their cooperation and material support. The authors would also like to thank for all Ayder comprehensive specialized hospital and Mekelle hospital staff members for their support during this study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors have declared that there are no conflicts of interest in this work.

Additional information

Funding

The study was carried out as part of our routine work.