Abstract
Introduction: A 6-month isoniazid as tuberculosis preventive therapy (TPT) for people living with HIV (PLHIV) was nationally introduced in Eritrea in 2014. However, its effectiveness in preventing tuberculosis (TB) and duration of protection was questioned by physicians. This study was, therefore, conducted to evaluate the impact of the isoniazid preventive therapy (IPT) primarily on the prevention of TB and duration of its protection in PLHIV. Methods: A retrospective cohort study was conducted that selected all eligible PLHIV attending HIV care clinics in all national and regional referral hospitals in Eritrea. Data was collected from patients’ clinical cards using a structured data extraction sheet. The association between use of IPT and outcomes of interest was assessed using a Cox proportional hazard regression model and Kaplan–Meier curve. Results: A total of 6803 patients were selected, which accounted for 75% of all PLHIV-accessing HIV care clinics in Eritrea. About 76% of patients were exposed to IPT while the remaining 24% were unexposed. The mean follow-up time was 4.9 years (SD 1.4). The incidence rate of TB was 1.7 and 10 cases per 1000 person-years in the exposed and unexposed, respectively. The unexposed had a higher risk of incident TB (adjusted hazard ratio [aHR] 3.75, 95% confidence interval [CI] 2.89, 6.13) and all-cause mortality (HR 2.41, 95% CI 1.85, 3.14) compared to the exposed. A Kaplan–Meier curve showed that the exposed group had a higher TB-free follow-up probability (98.8%) compared to the unexposed (95%) at 65 months of follow-up (p < 0.001). IPT protection decreased rapidly 6 months after isoniazid completion. Conclusion: Use of a 6-month isoniazid as TPT was found to be effective in reducing incident TB in PLHIV-accessing HIV care clinics in Eritrea. However, the protection appeared to diminish soon, namely 6 months after completion of isoniazid, which warrants immediate attention from policy makers.
| Original language | English |
|---|---|
| Pages (from-to) | 559-579 |
| Number of pages | 21 |
| Journal | Infectious Diseases and Therapy |
| Volume | 11 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Feb 2022 |
Bibliographical note
Funding Information:The authors would like to sincerely thank the staff of the study sites in general and those involved in data collection in particular. The authors would also like to acknowledge the staff of the Eritrean Medicines and Food Administration: Merhawi Bahta, Merhawi Debesai, Sirak Tefamariam and Yodit Fitsum for their supervisory role during data collection and entry. The authors appreciate pharmacy interns: Abel Tekle, Filipos Yohannes, Heaven Yohannes, Hermon Berhane, Lilay Berhane, Natnael Bereket, Natnael Russom, Saleh Idrisnur and pharmacist Liya Abraham who participated in data entry. Finally, the authors sincerely thank Iyassu Bahta, Director of the National Medicines and Food Administration for his commendable support at all levels of the project and the Communicable Disease Control (CDC) division of the Ministry of Health of the State of Eritrea for their immense cooperation, comments and partial funding of the study. This work was funded, in part, by the CDC Division of the Ministry of Health of the State of Eritrea (Global Fund HIV Grant—activity code 9.8). No funding or sponsorship was, however, received for publication of this article. The funding institution had no role in the design, interpretation and write-up of the article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Mulugeta Russom, Katia Verhamme and Bruno H. Stricker conceptualized the study. All authors contributed on the design and interpretation of the results. Henok G. Woldu was responsible for the data analysis. Mulugeta Russom supervised the data collection and analysis process and wrote the first draft of the manuscript. All authors critically reviewed the manuscript and provided their consent for publication. The whole research project was made under the supervision and guidance of Katia Verhamme and Bruno H. Stricker and funding acquisition was made by Mulugeta Russom. Mulugeta Russom, Henok G. Woldu, Araia Berhane, Daniel Y.B. Jeannetot, Bruno H. Stricker and Katia Verhamme have nothing to disclose. Ethical clearance to conduct the study was obtained from the Health Research Ethics and Protocol Review Committee of the Ministry of Health of the State of Eritrea (reference number 7-18/2020). Patients informed/written consent was waived as the study was retrospective. All data generated or analyzed during this study are included in this published article/as supplementary information files.
Funding Information:
This work was funded, in part, by the CDC Division of the Ministry of Health of the State of Eritrea (Global Fund HIV Grant—activity code 9.8). No funding or sponsorship was, however, received for publication of this article. The funding institution had no role in the design, interpretation and write-up of the article.
Publisher Copyright:
© 2022, The Author(s).
