1 Somé EN, et al. BMJ Open 2018;8:e019239. doi:10.1136/bmjopen-2017-019239 Open Access HIV-1 disease progression in immune- competent HIV-1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study Eric Nagaonle Somé, 1,2 Ingunn M S Engebretsen, 1 Nicolas Nagot, 3 Nicolas Yelbomkan Meda, 4 Roselyne Vallo, 3 Chipepo Kankasa, 5,6 James K Tumwine, 7 Mandisa Singata-Madliki, 8 Kim Harper, 8 G Justus Hofmeyr, 8 Philippe Van de Perre, 3 Thorkild Tylleskär, 1 on behalf of the ANRS 12174 Trial Group To cite: Somé EN, Engebretsen IMS, Nagot N, et al. HIV-1 disease progression in immune-competent HIV- 1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study. BMJ Open 2018;8:e019239. doi:10.1136/ bmjopen-2017-019239 ► Prepublication history for this paper is available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2017- 019239). Received 24 August 2017 Revised 17 December 2017 Accepted 14 February 2018 For numbered affliations see end of article. Correspondence to Dr Eric Nagaonle Somé; eric.nsome@gmail.com Research ABSTRACT Objective We have assessed HIV-1 disease progression among HIV-1-positive mothers in relation to duration of any or exclusive breast feeding in the context of ANRS 12174 trial. Methods The analysis was completed on 203, 212, 272 and 529 HIV-1-positive and lactating mothers with CD4 count >350 cells/µL from Burkina Faso, South Africa, Uganda and Zambia, respectively. The trial compared lamivudine and lopinavir/ritonavir as a peri-exposure prophylaxis during a 50-week follow-up time. A multiple logistic regression model was run with the mothers’ weight, CD4 count and HIV-1 viral load as separate dependent variables, then combined into a dependent composite endpoint called HIV-1 disease progression where HIV-1 viral load was replaced by the HIV-1 clinical stage. Exclusive or predominant breast feeding (EPBF) and any breastfeeding duration were the key explanatory variables. Results In the adjusted model, the associations between EPBF duration and weight change, CD4 cell count and the HIV-1 viral load were consistently insignifcant. The CD4 cell count was associated with a signifcantly higher mothers’ body mass index (BMI; a mean increase of 4.9 (95% CI 2.1 to 7.7) CD4 cells/ µL per each additional kilogram per square metre of BMI) and haemoglobin concentration (19.4 (95% CI 11.4 to 27.4) CD4 cells/µL per each additional gram per decilitre of haemoglobin concentration). There was no signifcant association between EPBF duration and HIV-1 disease progression. A higher education level was a factor associated with a slower HIV-1 disease progression. Conclusion Breast feeding was not a risk factor for a faster progression of HIV-1 disease in mothers of this cohort with a baseline CD4 cell count >350 cells/µL. Trial registration number NCT0064026; Post-results. INTRODUCTION  In 2015, 36.7 (34.0–39.8) million people were infected with HIV. Among them, 17.4 (16.1– 20.0) million were women of childbearing age. 1 2 HIV-1 prevalence was estimated between 5.3% and 6.5% among pregnant women in sub-Saharan Africa. 3 Because of the almost irreversible immune activation involved, HIV-1 infection creates a condition of metabolic stress that may result in wasting and immune depression. 4–7 Ten per cent weight loss and a CD4 count of <350 cells/μL in the context of HIV-1 infection have been recognised as major criteria of the diagnosis of AIDS. 8 This weight loss is also associated Strengths and limitations of this study ► Our study has been implemented in four countries in Africa, namely Burkina Faso (West), South Africa and Zambia (South), and Uganda (East), which made our sample representative of the wider sub-Sahara African population. ► The data were collected in the context of a rigorous clinical trial, which minimised the loss to follow-up, the missing data as well as other data collection er- rors, and therefore improved the quality of our data. ► However, the selection associated with the environ- ment of a clinical trial, usually quite different from a routine environment, may have biased our fndings. ► Nonetheless, the variables analysed separately as dependent variables or as part of our composite endpoints (mother’s weight, CD4 cell count, HIV-1 viral load or HIV-1 clinical stage) were suffciently robust and had a high validity. on 12 April 2019 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2017-019239 on 5 April 2018. Downloaded from