Efficacy and safety of short-cycle, dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a multicentre, open-label, randomised, parallel, two-arm, non-inferiority trial
Adeodata R Kekitiinwa MMed, Angus Jennings MSc, Mutsa Bwakura-Dangarembizi PhD, Cissy Kityo PhD, Prof Abraham Siika MMed, Prof Moherndran Archary PhD, Alexandra Green MSc, Lungile Jafta BComH, George Patrick Akabwai MMED, Prof Hilda Angela Mujuru MMed, Henry Mugerwa MSc, Cecilia Kiilu MMed, Rosie Mngqibisa MPH, Prof Janet Seeley PhD, Rashidah Nazzinda MBchB, Naomi Apoto MPH, Prof Simon Walker MSc, Prof David Burger PhD, Carlo Giaquinto MD, Resty Babirye Okello MSc, Godfrey Musoro MSc, Charity Wambui DrPH, Tiyara Arumugam MBChB, Magda Conway BAHons, Nadine Van Looy MSc, Annabelle South PhD, Alasdair Bamford PhD, Margaret J Thomason PhD, Deborah Ford PhD, Prof Sarah L Pett PhD, BREATHER Plus trial team, Sarah Pett, Deborah Ford, Margaret Thomason, Alasdair Bamford, Ellen White, Jessica Kirk, Angus Jennings, Helen Ainscough, Rebecca Dodds, Molly Bush, Simona Salomone, Hanh Nguyen, Anas Omar, Ben Spittle, Paul Crawley, Alexandra Green, George Pettitt, Jemima Shickle, Stephen Townsend, Hannah Sweeney, Margaret Hook, Sara Peres, Nadine Van Looy, Andy Sum, Diana Gibb, Annabelle South, Berta Terre-Torras, Elizabeth Chappell, Aoife Nolan, Adeodata Kekitiinwa, George Patrick Akabwai, Fredrick Katongole, Naomi Apoto, Resty Babirye Okello, Ronald Nabimba, Muzamil Nsibuka Kisekka, Collins Mujyanama, Gerald Agaba Muzorah, Gideon Ahimbisibwe, Florence Namuli, Rose Namaganda, Lameck Kiyimba, Angella Baita, Rachael Namuddu Kikabi, Henry Balwa, Susan Tukamuhebwa, Maria Benita Aino, Judith Tikabibamu, Anthony Kirabira, Lekku Lawrence, Barbra Nantume, Muhammad Lutalo, Diana Louis Anena, Rose Jacqueline Kadhuba, Patricia Nahirya Ntege, Teddy Kembabazi, Cissy Kityo, Victor Musiime, Shamim Nakabuye, Miriam Namasinga, Peace Hellen Masiga, Roselyn Kabasingo, Claire Nasaazi, Centurio Wandera, Josephine Kobusingye, Disan Mulima, Alex V Musiime, Faith Mbasani, Ezra Lutalo, Brenda Namukwaya Efrance, Odoch Denis, Baliruno David, Ampaire Phionah, Edgar Ayesiga Wandigali, Patrick Ssebunya, Barbara Mukanza, Rashidah Nazzinda, Ritah Mbabazi, Abigail Atwine, Juliet Ankunda, Priscilla Kyobutungi, Elizabeth Kaudha, Sharif Musumba, Jesca Nantale, Mariam Naabalamba, Mangadalen Nansaigi, Diana Antonia Rutebarika, Mary Nannungi, Benson Ouma, Edward Bagirigomwa, Eddie Rubanga, Josephine Namusanje, Henry Mugerwa, Crispus Katemba, Deborah Kahinju, Eram David Williams, Juliet Ategeka, Ocitti Sunday Paul Labeja, Joan Nantege, Shirat Nakabiri, Jeremy Kirunda, Charles Draleku, Jamilah Namwanga, Joan Nangiya, Baker Rubinga, Rodney Kazooba, Cate Naluyima, Christopher Lwanga, Faith Balmoi Labote, Dridah Nakiboneka, Bibian Nakigozi Nakato, Christine Nambi, Milly Ndigendawani, Jovia Kavuma, Timothy Lubwama, Frank Mbamanya, Nabuuma Haawa Muweesi, Carol Otike, Mwanje John Bosco, Anna Ritah Namuganga, Mutsawashe Bwakura-Dangarembizi, Kusum Nathoo, Hilda Mujuru, Misheck Phiri, Stuart Chitongo, Wendy Mapfumo, Sandra Musarurwa, Taona Mudzviti, Columbus Moyo, Shepherd Mudzingwa, Shirley Mutsai, Vivian Mumbiro, Joy Chimanzi, Makhosonke Ndlovu, Maureen Tshuma, Ruth Nhema, Ennie Chidziva, Cleopatra Langa, Godfrey Musoro, Dorinda Mukura, Edson Marimo, Tinashe Chidemo, Bernadette Malunda, Musunga Tomu, Lynnet Nyakudya, Nicholas Dhibi, Alfed Kateta, Sidney Sithole, Lynette Chibanda, Deka Vincent, Elaine Mwandiwata, Secrecy Gondo, Moses Chitsamatanga, Farai Selina Matimba, Tsitsi Gwenzi, Nathalie Mudzimirema, Allen Matubu, Prosper Sibonile Dube, Pia Ngwaru, Joyline Bhiri, Trust Mukanganiki, Vinie Kouamou, Rufaro Chivaura, Xeshelihle Mhlanga, Hazel Patricia Munyama, Sibusisiwe Weza, Vongai Margaret Chanaiwa, Shamiso Barbara Gwande, Constantine Mutata, Dorothy Murungu, Abraham Siika, Winstone Nyandiko, Cecilia Kiilu, Charity Wambui, Ronald Tonui, Viola Kirui, Caroline Watiri Maina, Florence Kiwunja Njulu, Cornelius Chege, Natalie Sang, Beatrice K. Jakait, Damaris Lagat, Salinah Cherutich, Benedister Kangogo Cheruiyot, Brian Odul, Hilda Kaziga, Teri Tarus, Getruth Jerop Kiptoo, Vincent Kipchirchir, Clinton Otieno Achida, Tom Oyoo Osoro, Jairus Kipyego, Violah Samoei, Martha Mokeira Mokaya, Wilson Lokitala Ekiru, Ruth Bosire, Rispher Chepkoech, Festus Kirwa Rugut, Matthew Justus Mutuku, Hellen Jerotich Kiplagat, Millicent Orido, Eslyne Jepkemboi, Vincent Otieno Onyango, Alice Mudogo, Mary Chebet, Joan Chepkurui Kotut, Philemon Kipchirchir Mutai, Eunice Jepkemboi, Julie Chepchumba Choge, Evans Ochieng Ouno, Cecilia Chebet Mengich, Amina Msuo Shali, Solomon Kimurgor Ngetich, Dorcas Akinyi Opot, Shauri Kahindi Gona, Richard Kipsang Kirui, Damaris Jepchumba Kiprutto, Mowlem Pierre, Dorcus Adhiambo, Nicholas Kigen, Sophia Simatwa, Michael Njenga, Cornelius Magut, Kennedy Oyamo, Edna Jepngetich, Gideon Obila, Lydiah Maru, Victor Kibet Langat, Iris Jaluha Sande, Scholastica Njeri Wanjiru, Martha Kaimuri Mwongela, Moherndran Archary, Sundrapragasen Pillay, Rosie Mngqibisa, Raziya Bobat, Nozibusiso Rejoice Mosia, Precious Sphiwe Cebekhulu, Nombuso Nkosi, Rashina Nundlal, Saajida Rizvi, Jabu Mkhulise, Innocentia Thandokuhle Mncube, Nathaniel Malatjie, Shingirai Chimene, Zethu Mnyandu, Sheleika Singh, Clement Pillay, Tiyara Arumugam, Shauna Francis, Michelle Moodley, Sylvia Nylobo, Fathima Mather, Ida Mundhree, Popi Shabalala, Ntombizonta Ignatia Phewa, Khombisile Muthwa, Simangele Abigail Bengu, Tshamand Fulufhelo Netshitangani, Rayania Premoutt, Kelly Shermon Clark, Mthokozisi Khuzwayo, Janet Seeley, Sarah Bernays, Nothando Ngwenya, Tawanda Makusha, Zinhle Ngubo, Phindile Guga, Londiwe Shandu, Tamlyn Seunanden, Stella Namukwaya, Allen Asiimwe, Alice Nassanga, Paul Revill, Simon Walker, Yingying Zhang, David Burger, Angela Colbers, Tom Jacobs, Lisanne Bevers, Magda Conway, Lungile Jafta, Mercy Shibemba, Carlo Giaquinto, Karina Butler, Sam Phiri, Avy Violari, Nathan Ford, Imelda Mahaka, Addy Kekitiinwa, Hebron Kalikwani, Priscilla Nakiwala, Anton Pozniak, Rodolphe Thiebaut, Jane Crawley, Justus Ashaba
{"title":"Efficacy and safety of short-cycle, dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a multicentre, open-label, randomised, parallel, two-arm, non-inferiority trial","authors":"Adeodata R Kekitiinwa MMed, Angus Jennings MSc, Mutsa Bwakura-Dangarembizi PhD, Cissy Kityo PhD, Prof Abraham Siika MMed, Prof Moherndran Archary PhD, Alexandra Green MSc, Lungile Jafta BComH, George Patrick Akabwai MMED, Prof Hilda Angela Mujuru MMed, Henry Mugerwa MSc, Cecilia Kiilu MMed, Rosie Mngqibisa MPH, Prof Janet Seeley PhD, Rashidah Nazzinda MBchB, Naomi Apoto MPH, Prof Simon Walker MSc, Prof David Burger PhD, Carlo Giaquinto MD, Resty Babirye Okello MSc, Godfrey Musoro MSc, Charity Wambui DrPH, Tiyara Arumugam MBChB, Magda Conway BAHons, Nadine Van Looy MSc, Annabelle South PhD, Alasdair Bamford PhD, Margaret J Thomason PhD, Deborah Ford PhD, Prof Sarah L Pett PhD, BREATHER Plus trial team, Sarah Pett, Deborah Ford, Margaret Thomason, Alasdair Bamford, Ellen White, Jessica Kirk, Angus Jennings, Helen Ainscough, Rebecca Dodds, Molly Bush, Simona Salomone, Hanh Nguyen, Anas Omar, Ben Spittle, Paul Crawley, Alexandra Green, George Pettitt, Jemima Shickle, Stephen Townsend, Hannah Sweeney, Margaret Hook, Sara Peres, Nadine Van Looy, Andy Sum, Diana Gibb, Annabelle South, Berta Terre-Torras, Elizabeth Chappell, Aoife Nolan, Adeodata Kekitiinwa, George Patrick Akabwai, Fredrick Katongole, Naomi Apoto, Resty Babirye Okello, Ronald Nabimba, Muzamil Nsibuka Kisekka, Collins Mujyanama, Gerald Agaba Muzorah, Gideon Ahimbisibwe, Florence Namuli, Rose Namaganda, Lameck Kiyimba, Angella Baita, Rachael Namuddu Kikabi, Henry Balwa, Susan Tukamuhebwa, Maria Benita Aino, Judith Tikabibamu, Anthony Kirabira, Lekku Lawrence, Barbra Nantume, Muhammad Lutalo, Diana Louis Anena, Rose Jacqueline Kadhuba, Patricia Nahirya Ntege, Teddy Kembabazi, Cissy Kityo, Victor Musiime, Shamim Nakabuye, Miriam Namasinga, Peace Hellen Masiga, Roselyn Kabasingo, Claire Nasaazi, Centurio Wandera, Josephine Kobusingye, Disan Mulima, Alex V Musiime, Faith Mbasani, Ezra Lutalo, Brenda Namukwaya Efrance, Odoch Denis, Baliruno David, Ampaire Phionah, Edgar Ayesiga Wandigali, Patrick Ssebunya, Barbara Mukanza, Rashidah Nazzinda, Ritah Mbabazi, Abigail Atwine, Juliet Ankunda, Priscilla Kyobutungi, Elizabeth Kaudha, Sharif Musumba, Jesca Nantale, Mariam Naabalamba, Mangadalen Nansaigi, Diana Antonia Rutebarika, Mary Nannungi, Benson Ouma, Edward Bagirigomwa, Eddie Rubanga, Josephine Namusanje, Henry Mugerwa, Crispus Katemba, Deborah Kahinju, Eram David Williams, Juliet Ategeka, Ocitti Sunday Paul Labeja, Joan Nantege, Shirat Nakabiri, Jeremy Kirunda, Charles Draleku, Jamilah Namwanga, Joan Nangiya, Baker Rubinga, Rodney Kazooba, Cate Naluyima, Christopher Lwanga, Faith Balmoi Labote, Dridah Nakiboneka, Bibian Nakigozi Nakato, Christine Nambi, Milly Ndigendawani, Jovia Kavuma, Timothy Lubwama, Frank Mbamanya, Nabuuma Haawa Muweesi, Carol Otike, Mwanje John Bosco, Anna Ritah Namuganga, Mutsawashe Bwakura-Dangarembizi, Kusum Nathoo, Hilda Mujuru, Misheck Phiri, Stuart Chitongo, Wendy Mapfumo, Sandra Musarurwa, Taona Mudzviti, Columbus Moyo, Shepherd Mudzingwa, Shirley Mutsai, Vivian Mumbiro, Joy Chimanzi, Makhosonke Ndlovu, Maureen Tshuma, Ruth Nhema, Ennie Chidziva, Cleopatra Langa, Godfrey Musoro, Dorinda Mukura, Edson Marimo, Tinashe Chidemo, Bernadette Malunda, Musunga Tomu, Lynnet Nyakudya, Nicholas Dhibi, Alfed Kateta, Sidney Sithole, Lynette Chibanda, Deka Vincent, Elaine Mwandiwata, Secrecy Gondo, Moses Chitsamatanga, Farai Selina Matimba, Tsitsi Gwenzi, Nathalie Mudzimirema, Allen Matubu, Prosper Sibonile Dube, Pia Ngwaru, Joyline Bhiri, Trust Mukanganiki, Vinie Kouamou, Rufaro Chivaura, Xeshelihle Mhlanga, Hazel Patricia Munyama, Sibusisiwe Weza, Vongai Margaret Chanaiwa, Shamiso Barbara Gwande, Constantine Mutata, Dorothy Murungu, Abraham Siika, Winstone Nyandiko, Cecilia Kiilu, Charity Wambui, Ronald Tonui, Viola Kirui, Caroline Watiri Maina, Florence Kiwunja Njulu, Cornelius Chege, Natalie Sang, Beatrice K. Jakait, Damaris Lagat, Salinah Cherutich, Benedister Kangogo Cheruiyot, Brian Odul, Hilda Kaziga, Teri Tarus, Getruth Jerop Kiptoo, Vincent Kipchirchir, Clinton Otieno Achida, Tom Oyoo Osoro, Jairus Kipyego, Violah Samoei, Martha Mokeira Mokaya, Wilson Lokitala Ekiru, Ruth Bosire, Rispher Chepkoech, Festus Kirwa Rugut, Matthew Justus Mutuku, Hellen Jerotich Kiplagat, Millicent Orido, Eslyne Jepkemboi, Vincent Otieno Onyango, Alice Mudogo, Mary Chebet, Joan Chepkurui Kotut, Philemon Kipchirchir Mutai, Eunice Jepkemboi, Julie Chepchumba Choge, Evans Ochieng Ouno, Cecilia Chebet Mengich, Amina Msuo Shali, Solomon Kimurgor Ngetich, Dorcas Akinyi Opot, Shauri Kahindi Gona, Richard Kipsang Kirui, Damaris Jepchumba Kiprutto, Mowlem Pierre, Dorcus Adhiambo, Nicholas Kigen, Sophia Simatwa, Michael Njenga, Cornelius Magut, Kennedy Oyamo, Edna Jepngetich, Gideon Obila, Lydiah Maru, Victor Kibet Langat, Iris Jaluha Sande, Scholastica Njeri Wanjiru, Martha Kaimuri Mwongela, Moherndran Archary, Sundrapragasen Pillay, Rosie Mngqibisa, Raziya Bobat, Nozibusiso Rejoice Mosia, Precious Sphiwe Cebekhulu, Nombuso Nkosi, Rashina Nundlal, Saajida Rizvi, Jabu Mkhulise, Innocentia Thandokuhle Mncube, Nathaniel Malatjie, Shingirai Chimene, Zethu Mnyandu, Sheleika Singh, Clement Pillay, Tiyara Arumugam, Shauna Francis, Michelle Moodley, Sylvia Nylobo, Fathima Mather, Ida Mundhree, Popi Shabalala, Ntombizonta Ignatia Phewa, Khombisile Muthwa, Simangele Abigail Bengu, Tshamand Fulufhelo Netshitangani, Rayania Premoutt, Kelly Shermon Clark, Mthokozisi Khuzwayo, Janet Seeley, Sarah Bernays, Nothando Ngwenya, Tawanda Makusha, Zinhle Ngubo, Phindile Guga, Londiwe Shandu, Tamlyn Seunanden, Stella Namukwaya, Allen Asiimwe, Alice Nassanga, Paul Revill, Simon Walker, Yingying Zhang, David Burger, Angela Colbers, Tom Jacobs, Lisanne Bevers, Magda Conway, Lungile Jafta, Mercy Shibemba, Carlo Giaquinto, Karina Butler, Sam Phiri, Avy Violari, Nathan Ford, Imelda Mahaka, Addy Kekitiinwa, Hebron Kalikwani, Priscilla Nakiwala, Anton Pozniak, Rodolphe Thiebaut, Jane Crawley, Justus Ashaba","doi":"10.1016/s2352-3018(25)00326-1","DOIUrl":null,"url":null,"abstract":"Short-cycle antiretroviral therapy (ART), comprising 5 days on and 2 days off treatment, offers the potential for ART-free weekends, reduced toxicity, and improved quality of life for adolescents living with HIV, who typically have worse treatment outcomes than other age groups. We aimed to compare the efficacy and safety of short-cycle ART containing tenofovir disoproxil fumarate–lamivudine–dolutegravir with continuous ART in adolescents living with HIV in Africa.","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"51 1","pages":""},"PeriodicalIF":13.0000,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Hiv","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/s2352-3018(25)00326-1","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Short-cycle antiretroviral therapy (ART), comprising 5 days on and 2 days off treatment, offers the potential for ART-free weekends, reduced toxicity, and improved quality of life for adolescents living with HIV, who typically have worse treatment outcomes than other age groups. We aimed to compare the efficacy and safety of short-cycle ART containing tenofovir disoproxil fumarate–lamivudine–dolutegravir with continuous ART in adolescents living with HIV in Africa.
期刊介绍：
The Lancet HIV is an internationally trusted source of clinical, public health, and global health knowledge with an Impact Factor of 16.1. It is dedicated to publishing original research, evidence-based reviews, and insightful features that advocate for change in or illuminates HIV clinical practice. The journal aims to provide a holistic view of the pandemic, covering clinical, epidemiological, and operational disciplines. It publishes content on innovative treatments and the biological research behind them, novel methods of service delivery, and new approaches to confronting HIV/AIDS worldwide. The Lancet HIV publishes various types of content including articles, reviews, comments, correspondences, and viewpoints. It also publishes series that aim to shape and drive positive change in clinical practice and health policy in areas of need in HIV. The journal is indexed by several abstracting and indexing services, including Crossref, Embase, Essential Science Indicators, MEDLINE, PubMed, SCIE and Scopus.
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