Medication Side Effects and Retention in HIV Treatment: A Regression Discontinuity Study of Tenofovir Implementation in South Africa and Zambia

Author:

Brennan Alana T123,Bor Jacob123,Davies Mary-Ann4,Wandeler Gilles56,Prozesky Hans7,Fatti Geoffrey8,Wood Robin9,Stinson Kathryn4,Tanser Frank101112,Bärnighausen Till101314,Boulle Andrew41516,Sikazwe Izukanji17,Zanolini Arianna17,Fox Matthew P123

Affiliation:

1. Department of Global Health, School of Public Health, Boston University, Boston, Massachusetts

2. Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

3. Department of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts

4. Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa

5. Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland

6. Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

7. Division of Infectious Diseases, Department of Medicine, Tygerberg Academic Hospital, University of Stellenbosch, Cape Town, South Africa

8. Kheth’Impilo AIDS Free Living, Cape Town, South Africa

9. The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

10. Africa Health Research Institute, Durban, South Africa

11. School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa

12. Research Department of Infection and Population Health, University College London, London, United Kingdom

13. Institute of Public Health, School of Medicine, Heidelberg University, Heidelberg, Germany

14. Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

15. Department of Health, Provincial Government of the Western Cape, Cape Town, South Africa

16. Division of Public Health Medicine, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa

17. Center for Infectious Disease Research in Zambia, Lusaka, Zambia

Abstract

Abstract Tenofovir is less toxic than other nucleoside reverse-transcriptase inhibitors used in antiretroviral therapy (ART) and may improve retention of human immunodeficiency virus (HIV)–infected patients on ART. We assessed the impact of national guideline changes in South Africa (2010) and Zambia (2007) recommending tenofovir for first-line ART. We applied regression discontinuity in a prospective cohort study of 52,294 HIV-infected adults initiating first-line ART within 12 months (±12 months) of each guideline change. We compared outcomes in patients presenting just before and after the guideline changes using local linear regression and estimated intention-to-treat effects on initiation of tenofovir, retention in care, and other treatment outcomes at 24 months. We assessed complier causal effects among patients starting tenofovir. The new guidelines increased the percentages of patients initiating tenofovir in South Africa (risk difference (RD) = 81 percentage points, 95% confidence interval (CI): 73, 89) and Zambia (RD = 42 percentage points, 95% CI: 38, 45). With the guideline change, the percentage of single-drug substitutions decreased substantially in South Africa (RD = −15 percentage points, 95% CI: −18, −12). Starting tenofovir also reduced attrition in Zambia (intent-to-treat RD = −1.8% (95% CI: −3.5, −0.1); complier relative risk = 0.74) but not in South Africa (RD = −0.9% (95% CI: −5.9, 4.1); complier relative risk = 0.94). These results highlight the importance of reducing side effects for increasing retention in care, as well as the differences in population impact of policies with heterogeneous treatment effects implemented in different contexts.

Funder

United States Agency for International Development

US National Institutes of Health

Alexander von Humboldt Foundation

German Federal Ministry of Education and Research

Wellcome Trust

European Commission

Clinton Health Access Initiative

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institute of Allergy and Infectious Diseases

Fogarty International Center

Publisher

Oxford University Press (OUP)

Subject

Epidemiology

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