Excellent retention, virologic and clinical outcomes after transitioning from an antiretroviral treatment clinical trial to locally-provided care and treatment in Africa

Fredrick Sawe; Michael D. Hughes; Yajing Bao; Evelyn Hogg; Douglas Shaffer; Jacob Phulusa; Tebogo Kakhu; Francesca Conradie; Margaret Kasaro; Rosie Mngqbisa; Abraham Siika; Diana Atwiine; Tsungai Chipato; James McIntyre; Judith Currier; Shahin Lockman

doi:10.18203/2349-3259.ijct20170307

Authors

Fredrick Sawe Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA); Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA
Michael D. Hughes Harvard School of Public Health, Boston, MA, USA
Yajing Bao Harvard School of Public Health, Boston, MA, USA
Evelyn Hogg Social & Scientific Systems, Inc., Silver Spring, MD USA
Douglas Shaffer Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA)
Jacob Phulusa University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi
Tebogo Kakhu Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana
Francesca Conradie University of Witwatersrand Clinical HIV Research Unit Johannesburg South Africa
Margaret Kasaro Centre for Infectious Disease Research in Zambia , Lusaka , Zambia
Rosie Mngqbisa University of KwaZulu-Natal, Durban, South Africa
Abraham Siika Department of Internal Medicine, College of Health Sciences, School of Medicine, Moi University, Eldoret, Kenya
Diana Atwiine Joint Clinical Research Centre Kampala, Uganda
Tsungai Chipato University of Zimbabwe, Harare, Zimbabwe
James McIntyre Anova Health Institute, Johannesburg, South Africa
Judith Currier University of California Los Angeles, Los Angeles, CA, USA
Shahin Lockman Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone; BotswanaBrigham and Women’s Hospital, Boston, Massachusetts, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20170307

Keywords:

HIV, Antiretroviral therapy, Post clinical trial care, Resource limited settings

Abstract

Background: Little is known about outcomes among clinical trial participants following completion of study-provided care and treatment in resource limited settings. We sought to describe outcomes among HIV clinical trial participants after transitioning to local routine care in Africa.

Methods: In the OCTANE study, 741 women with CD4 <200 cells/mm³ in 7 African countries were randomized to initiate antiretroviral treatment (ART) with tenofovir/emtricitabine (TDF/FTC) plus either lopinavir/ritonavir (LPV/r) or nevirapine (NVP). When study-specified ART ended (48-191 weeks after study entry), participants transitioned to locally-provided HIV care and non-study ART. Consenting participants were interviewed and had toxicity labs, CD4 and HIV-1 RNA testing, and clinical outcomes assessed at 12 and 72 weeks after transition to local care.

Results: Five hundred thirteen (77%) of the 669 women in follow-up at completion of the interventional trial participate in the extended follow-up. 513 women, 476 (93%) had HIV-1 RNA <400 cp/mL at time of transition, and 489 (95%) completed follow-up. Seventy-seven women (19%) had a total of 99 antiretroviral regimen changes during post-trial follow-up. 30% of the 99 regimen changes-were due to lack of local drug availability. Thirteen (3%) women had Grade ≥3 laboratory abnormalities and 3 experienced worsening of the WHO HIV stage. Two women died. Eighty-nine percent of 484 with results had HIV-1 RNA ≤400 cp/mL at 72 weeks after transition to local non-study HIV care and treatment.

Conclusions: The vast majority of women were able to continue key components of their ART and to maintain virologic suppression through 72 weeks of locally-provided post-study care.

Trial registration: ClinicalTrials.gov NCT00089505

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Author Biography

Fredrick Sawe, Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA); Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA

Senior Deputy Director

References

Centers for Disease Control and Prevention MMWR Morbidity Mortality Weekly Report. Scale-up of HIV Viral Load Monitoring — Seven Sub-Saharan African Countries. Centers for Disease Control and Prevention MMWR Morbidity Mortality Weekly. 2015;64(46):

Holmes CB, Sanne I. Changing models of care to improve progression through the HIV treatment cascade in different populations. Curr Opin HIV AIDS. 2015;10:447–50.

Khabala KB, Edwards JK, Baruani B, Sirengo M, Musembi P, Kosgei RJ, et al. Medication Adherence Clubs: a potential solution to managing large numbers of stable patients with multiple chronic diseases in informal settlements. Trop Med Int Health. 2015;20(10):1265-70.

Brennan AT, Long L, Maskew M, Sanne I, Jaffray I, MacPhail P, et al. Outcomes of stable HIV-positive patients down-referred from a doctor-managed antiretroviral therapy clinic to a nurse-managed primary health clinic for monitoring and treatment. AIDS. 2011;25:2027–36.

Dawson L, Klingman K, Marrazzo J. Addressing standards of care in resource-limited settings J Acquir Immune Defic Syndr. 2014;65(1):10-4.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Ancillary Care: From Theory to Practice in Int Clin Res Public Health Ethics. 2013;6(2):154–69.

Sofaer N. Reciprocity-Based Reasons For Benefiting Research Participants: Most Fail, The Most Plausible Is Problematic. Bioethics. 2014;28(9):456-71.

Millum J. Post-trial Access to Antiretrovirals: Who Owes What to Whom? Bioethics. 201125(3):145–54.

Dawson L, Zwerski S. Clinical Trial Design For Hiv Prevention Research: Determining Standards Of Prevention. 2015;29(5):316-23.

Iserson KV, Biros MH, James HC. Challenges in International Medicine: Ethical Dilemmas, Unanticipated Consequences, and Accepting Limitations. Acad Emergency Med. 2012;19(6):683-92.

Pratt B, Loff B. A framework to link international clinical research to the promotion of justice in global health. Bioethics. 2014;28(8):387-96.

Godfrey C, Payton M, Tasker S, Proestel S, Schouten JT. Ensuring Participant Safety and Trial Integrity with Clinical Trials Oversight. J Acquir Immune Defic Syndr. 2014;65(1):40–3.

Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, Conradie F, et al. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010;363(16):1499-509.

Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, Chipato T, et al. Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med. 2012;9(6):e1001236.

The Belmont Report. 1979. Available at http://www.hhs.gov/ohrp/ humansubjects/guidance /belmont.html. Accessed on 23 November 2016.

Maman D, Zeh C, Mukui I, Masson BKS, Opolo V, Szumilin E, et al. Cascade of HIV care and population viral suppression in a high-burden region of Kenya. AIDS. 2015;29:1557–65.

Fox MP, Rosen S. Patient retention in antiretroviral therapy. programs up to three years on treatment in sub-Saharan Africa, 2007–2009: systematic review. Trop Med Intl Health. 2010;15(1):1–15.

National AIDS and STI Control Programme (NASCOP), Kenya. Kenya AIDS Indicator Survey 2012: Final Report. Nairobi, NASCOP. 2014.