UNAIDS. The path that ends AIDS: UNAIDS Global AIDS Update 2023. Geneva: Joint United Nations Programme on HIV/AIDS; 2023. https://www.unaids.org/sites/default/files/media_asset/2023-unaids-global-aids-update_en.pdf Accessed 18 Jul 2025.
Van de Perre P, Goga A, Ngandu N, Nagot N, Moodley D, King R, et al. Eliminating postnatal HIV transmission in high incidence areas: need for complementary biomedical interventions. Lancet. 2021. https://doi.org/10.1016/S0140-6736(21)00570-5.
World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring. Recommendations for a public health approach. 2021. https://www.who.int/publications/i/item/9789240031593. Accessed 17 Jul 2025.
World Health Organization. Overview of WHO recommendations on HIV and sexually transmitted infection testing, prevention, treatment, care and service delivery. 2025. https://iris.who.int/server/api/core/bitstreams/16073301-792e-4153-9ce9-ad7a56ea37a7/content. Accessed 4 Nov 2025.
Thior I, Lockman S, Smeaton LM, Shapiro RL, Wester C, Heymann SJ, et al. Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana: a randomized trial: the Mashi Study. JAMA. 2006. https://doi.org/10.1001/jama.296.7.794.
Kilewo C, Karlsson K, Massawe A, Lyamuya E, Swai A, Mhalu F, et al. Prevention of mother-to-child transmission of HIV-1 through breast-feeding by treating infants prophylactically with lamivudine in Dar es Salaam, Tanzania: the Mitra Study. J Acquir Immune Defic Syndr. 2008. https://doi.org/10.1097/QAI.0b013e31816e395c.
Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, et al. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008. https://doi.org/10.1056/NEJMoa0801941.
Chasela CS, Hudgens MG, Jamieson DJ, Kayira D, Hosseinipour MC, Kourtis AP, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med. 2010. https://doi.org/10.1056/NEJMoa0911486.
Article PubMed PubMed Central Google Scholar
Coovadia HM, Brown ER, Fowler MG, Chipato T, Moodley D, Manji K, et al. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. Lancet. 2012. https://doi.org/10.1016/S0140-6736(11)61653-X.
Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, et al. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016. https://doi.org/10.1016/S0140-6736(15)00984-8.
Flynn PM, Taha TE, Cababasay M, Fowler MG, Mofenson LM, Owor M, et al. Prevention of HIV-1 transmission through breastfeeding: efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE): a randomized, open-label, clinical trial. J Acquir Immune Defic Syndr. 2018. https://doi.org/10.1097/QAI.0000000000001612.
Article PubMed PubMed Central Google Scholar
Mennecier A, Sakana BLD, D’Ottavi M, Tassembedo S, Moles JP, Kania D, et al. An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV). BMC Infect Dis. 2024. https://doi.org/10.1186/s12879-024-09910-z.
Article PubMed PubMed Central Google Scholar
Kankasa C, Mennecier A, Sakana BLD, Moles JP, Mwiya M, Chunda-Liyoka C, et al. Optimised prevention of postnatal HIV transmission in Zambia and Burkina Faso (PROMISE-EPI): a phase 3, open-label, randomised controlled trial. Lancet. 2024. https://doi.org/10.1016/S0140-6736(23)02464-9.
Ruel T, Penazzato M, Zech JM, Archary M, Cressey TR, Goga A, et al. Novel approaches to postnatal prophylaxis to eliminate vertical transmission of HIV. Glob Health Sci Pract. 2023. https://doi.org/10.9745/GHSP-D-22-00401.
Article PubMed PubMed Central Google Scholar
World Health Organization. Updated recommendations on HIV prevention, infant diagnosis and antiretroviral initiation and monitoring. 2021. https://iris.who.int/bitstream/handle/10665/340190/9789240022232-eng.pdf?sequence=1. Accessed 26 May 2025.
Kania D, Moles JP, Rutagwera D, Kadeba FE, D'Ottavi M, Tonga M, et al. Maternal HIV viral load threshold for guiding for guiding extended infant prophylaxis initiation. In: 30th Conference on retroviruses and opportunistic infections, Seattle, WA, February 19–22, 2023 (abstract 777.5).
Six Week Extended-Dose Nevirapine (SWEN) Study Team. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet. 2008. https://doi.org/10.1016/S0140-6736(08)61114-9.
Chi BH, Chintu N, Cantrell RA, Kankasa C, Kruse G, Mbewe F, et al. Addition of single-dose tenofovir and emtricitabine to intrapartum nevirapine to reduce perinatal HIV transmission. J Acquir Immune Defic Syndr. 2008. https://doi.org/10.1097/QAI.0b013e3181743969.
Article PubMed PubMed Central Google Scholar
Mennecier A, Matoka B, Wilfred-Tonga MM, Chunda-Liyoka C, Mwiya M, Nagot N, et al. Facilitators and barriers to infant post-natal HIV prophylaxis, a qualitative sub-study of the PROMISE-EPI trial in Lusaka, Zambia. Front Public Health. 2023. https://doi.org/10.3389/fpubh.2023.1242904.
Article PubMed PubMed Central Google Scholar
Jacobs TG, Schouwenburg S, Penazzato M, Archary M, Ruel TD, van den Anker J, et al. What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies. Lancet HIV. 2022. https://doi.org/10.1016/S2352-3018(22)00121-7.
European Medicine Agency. Kaletra: EPAR-product information. 2025. https://www.ema.europa.eu/en/documents/product-information/kaletra-epar-product-information_en.pdf. Accessed 5 Jan 2026.
Clinical Info HIV.gov. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. 2024. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/management-infants-utero-intrapartum-breastfeeding-hiv-exposure?guideline%5B0%5D=title_bookpart%3APerinatal+HIV+Clinical+Guidelines&redirected=1. Accessed 26 May 2025.
Pacifici GM. Pharmacokinetics of antivirals in neonate. Early Hum Dev. 2005. https://doi.org/10.1016/j.earlhumdev.2005.06.001.
Giaquinto C, Rampon O, Penazzato M, Fregonese F, De Rossi A, D’Elia R. Nucleoside and nucleotide reverse transcriptase inhibitors in children. Clin Drug Investig. 2007. https://doi.org/10.2165/00044011-200727080-00001.
Monnin A, Nagot N, Periès M, Vallo R, Meda N, Singata-Madliki M, et al. Mitochondrial DNA parameters in blood of infants receiving lopinavir/ritonavir or lamivudine prophylaxis to prevent breastfeeding transmission of HIV-1. J Clin Med. 2020. https://doi.org/10.3390/jcm9092972.
Article PubMed PubMed Central Google Scholar
Monnin A, Nagot N, Eymard-Duvernay S, Meda N, Tumwine JK, Tylleskär T, et al. Health outcomes at school age among children who are HIV-exposed but uninfected with detected mitochondrial DNA depletion at one year. J Clin Med. 2020. https://doi.org/10.3390/jcm9113680.
Article PubMed PubMed Central Google Scholar
Monnin A, Desquiret-Dumas V, Meda N, Goudenege D, de Van Perre P, Reynier P, et al. Mitochondrial DNA instability is common in HIV-exposed uninfected newborns. J Clin Med. 2021. https://doi.org/10.3390/jcm10112399.
Article PubMed PubMed Central Google Scholar
Desquiret-Dumas V, D’Ottavi M, Monnin A, Goudenège D, Méda N, Vizeneux A, et al. Long-term persistence of mitochondrial DNA instability in HIV-exposed uninfected children during and after exposure to antiretroviral drugs and HIV. Biomedicine. 2022. https://doi.org/10.3390/biomedicines10081786.
Gay L, Desquiret-Dumas V, Nagot N, Rapenne C, de Van Perre P, Reynier P, et al. Long-term persistence of mitochondrial dysfunctions after viral infections and antiviral therapies: a review of mechanisms involved. J Med Virol. 2024. https://doi.org/10.1002/jmv.29886.
Kappelhoff BS, Huitema AD, van Leth F, Robinson PA, MacGregor TR, Lange JMA, et al. Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study. HIV Clin Trials. 2005. https://doi.org/10.1310/B5VU-FU5F-QNWC-UDCK.
Back DJ, Burger DM, Flexner CW, Gerber JG. The pharmacology of antiretroviral nucleoside and nucleotide reverse transcriptase inhibitors: implications for once-daily dosing. J Acquir Immune Defic Syndr. 2005. https://doi.org/10.1097/01.qai.0000168882.67942.3f.
Benaboud S, Ekouévi DK, Urien S, Rey E, Arrivé E, Blanche S, et al. Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates. Antimicrob Agents Chemother. 2011. https://doi.org/10.1128/AAC.00631-10.
Article PubMed PubMed Central Google Scholar
Bazzoli C, Jullien V, Le Tiec C, Rey E, Mentré F, Taburet AM. Intracellular pharmacokinetics of antiretroviral drugs in HIV-Infected patients, and their correlation with drug action. Clin Pharmacokinet. 2010. https://doi.org/10.2165/11318110-000000000-00000.
Koulinska IN, Villamor E, Chaplin B, Msamanga G, Fawzi W, Renjifo B, et al. Transmission of cell-free and cell-associated HIV-1 through breast-feeding. J Acquir Immune Defic Syndr. 2006. https://doi.org/10.1097/01.qai.0000179424.19413.24.
Comments (0)