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1. Intramuscular depot medroxyprogesterone acetate accentuates bone loss associated with tenofovir disoproxil fumarate-containing antiretroviral therapy initiation in young women living with HIV (the BONE: CARE study): a prospective cohort study in Uganda

Author

Flavia Kiweewa Matovu, Noah Kiwanuka, Martin Nabwana, Delia Scholes, Philippa Musoke, Mary Glenn Fowler, Mags E Beksinska, John M Pettifor, Todd T Brown, Flavia Matovu Kiweewa, Clemensia Nakabiito, Faith Nawagi, Betty Kamira, Esther Isingel, Stephen Bule, Violet Kukundakwe, Andrew Kateregga, Mary (Maria) Musisi, Paula Mubiru Namayanja, Dorothy Mirembe, Mary Speciosa Mbabali, Sarah Mulebeke, Joselyne Nabisere, Joyce Nakakande, Nicholas Matovu, Dorah Nakaye, Joshua Wynne, Faith Mulumba, Restituta Mukasa, Masitula Ssewanyana, Hadijah Kalule Nabunya, Florence Asiimwe Biira, Erinah Kyomukama, Suzan Nampiira, Aisha Zalwago, Margaret l Namuganga, Deborah Mwebaza, Prossy Ethel Namuli, Caroline Tulina, Florence Sempa Kikonyogo, Regina Bukenya Nabatanzi, Rosemary Muwawu, Jane Nsubuga Musisi, Margaret Nakato Saava, Mary Mukasa Kagwa Najjemba, Winfred Kaahwa, Rose Namwanje Mukalazi, Miriam Magomu Takhuli, Osman Sawsan, Margaret Mugenyi, Mary Agnes Mugagga, Francis Sserugo, Agnes Namuddu, Doreen Kemigisha, Justine Nakyeyune, Caroline Kawuma Nassozi, Juliet Asello, Zaam Zinda Nakawungu, Olivia Higiro Kaboggoza, Sarah Babirye Ssebabi, Bertha Birungi, Ruth Lutabi Ssentogo, Michael Charles Mubiru, Winnie Nansamba, Stella Nalusiba Kalungi, Luke Erismus Bukenya, Prossy Asiimwe, James Amos Bazira, Sulaiman Katongole, Wenceslaus Twinomujuni, Susan Nakacwa, Joanita Nankya Baddokwaya, Alice Margaret Elwana, Juliet Nanyonjo, Susan Adikini, Justine Nalwoga, Godfrey Rwanzogyera, Fabian Okello, Daniel Kabenge Kiiza, Emmanuel Mayanja, Francis Katongole, Max Kiwewa, Francis Onen, Joseph Mutebo, Dick Mukasa, Joshua Tamale, and Ismael Kibirige

Subjects
Adult, Male, Young Adult, Bone Density, Contraceptive Agents, Female, Humans, Female, HIV Infections, Uganda, General Medicine, Medroxyprogesterone Acetate, Prospective Studies, Tenofovir
Abstract

Tenofovir disoproxil fumarate (TDF) and intramuscular depot medroxyprogesterone acetate (DMPA-IM) are independently associated with reduced bone mineral density (BMD). We aimed to assess the combined effects of DMPA-IM use and TDF initiation on BMD in young adult women living with HIV over two years, compared with age-matched people without HIV.Th BONE: CARE study was a prospective cohort study that recruited women aged 18-35 years from 11 HIV care and general health facilities in Kampala, Uganda. The participants were classified into four groups on the basis of their combination of HIV status, TDF use, and DMPA-IM use, as follows: women living with HIV initiating TDF-containing antiretroviral therapy (ART) with DMPA-IM (HIV positive, DMPA positive, and TDF positive); women living with HIV using DMPA-IM but not eligible for ART as per local guidelines at the time of enrolment into the study (HIV positive, DMPA positive, and TDF negative); women living with HIV initiating TDF-containing ART without DMPA-IM (HIV positive, DMPA negative, and TDF positive); and controls without HIV using non-hormonal contraceptives (HIV negative, DMPA negative, and TDF negative). BMD of the lumbar spine, total hip, and femoral neck were measured using semiannual dual-energy x-ray absorptiometry at enrolment and at intervals every 6 months thereafter. We assessed percentage change in mean BMD.Between March 30, 2016, and Oct 19, 2017, we enrolled 265 women living with HIV initiating ART (159 DMPA-IM users and 106 non-hormonal contraceptive users), 187 women living with HIV using DMPA-IM but not ART, and 69 controls without HIV. Mean age was 26·1 years (SD 4·2). BMD declined significantly from baseline in women living with HIV on TDF with versus without DMPA-IM at the lumbar spine (-3·406% [95% CI -3·969 to -2·844] vs -1·111% [-1·929 to -0·293]; p0·0001), total hip (-3·856% [-4·449 to -3·264] vs -1·714% [-2·479 to -0·949]; p=0·0002), and femoral neck (-4·422% [-5·078 to -3·766] vs -1·999% [-3·022 to -0·976]; p=0·0002), increased in controls at the lumbar spine (1·5% change), and remained unchanged at total hip and femoral neck (-0·1% change). Concurrent use of TDF and DMPA-IM resulted in significantly greater BMD decline (p0·0001) than TDF alone (lumbar spine -2·677% [95% CI -3·743 to -1·611]; p0·0001; total hip -2·518% [-3·575 to -1·461]; p0·0001; and femoral neck -2·907 [-4·132 to -1·683]; p0·0001) or than controls (lumbar spine -4·970% [-6·391 to -3·549]; p0·0001; total hip -4·151% [-5·579 to -2·724]; p0.0001; and femoral neck -4·773% [-6·424 to -3·122]; p0·0001) INTERPRETATION: Concomitant DMPA-IM use resulted in a doubling of BMD loss in women living with HIV initiating TDF-containing ART. Identification of safer contraceptive and bone-sparing ART options should be prioritised for optimal care of women living with HIV.National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.

Published
2021

2. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

Jared M Baeten, Thesla Palanee-Phillips, Nyaradzo M Mgodi, Ashley J Mayo, Daniel W Szydlo, Gita Ramjee, Brenda Gati Mirembe, Felix Mhlanga, Portia Hunidzarira, Leila E Mansoor, Samantha Siva, Vaneshree Govender, Bonus Makanani, Logashvari Naidoo, Nishanta Singh, Gonasagrie Nair, Lameck Chinula, Urvi M Parikh, John W Mellors, Iván C Balán, Kenneth Ngure, Ariane van der Straten, Rachel Scheckter, Morgan Garcia, Melissa Peda, Karen Patterson, Edward Livant, Katherine Bunge, Devika Singh, Cindy Jacobson, Yuqing Jiao, Craig W Hendrix, Zvavahera M Chirenje, Clemensia Nakabiito, Taha E Taha, Judith Jones, Kristine Torjesen, Annalene Nel, Zeda Rosenberg, Lydia E Soto-Torres, Sharon L Hillier, Elizabeth R Brown, Dorothy Aanyu, John Abima, Janne Abullarade, Priyanka Agarwal, Surabhi Ahluwalia, Simon Africa Akasiima, Carolyne Agwau Akello, Samuel Albert, Motsamai Alphale, Calins Alphonse, Lucy Apeduno, Sara Aranda, Orly Aridor, Shakeera Arnolds, Prossy Asiimwe, Millicent Atujuna, Didas Atwebembere, Lakshmi Baboolall, Kiran Badana, Jared M. Baeten, David Balamusani, Iván C. Balán, Gabriel Banda, Towera Whitney Banda, Jennifer Baugh, James Amos Baziira, May Beamer, Sivuyisiwe Asanda Bebeza, Linda-Gail Bekker, Ian Bell, Meagan Bemer, Richard Berman, Jennifer Berthiaume, Linda Bezak, Yashveer Bhagwandin, Hassen Anwar Bhayat, Nokulunga Bhengu, Sonto Bhengu, Aruna Bhoola, Florence Asiimwe Biira, Daniel Bittoni, Roberta Black, Nombuso Jacqueline Blose, Pearl Boks, Stephen Gordon Bolton, Phathiswa Botya, Amanda Brown, Elizabeth Brown, Helen Brown, Robyn Helen Bruce, Luke Erismus Bukenya, Aidah Bukirwa, Lisa Bunts, Fezile Buthelezi, Mbongeleni William Buthelezi, Samkelisiwe Dumisile Buthelezi, Rose Byogero, Samiksha Byroo, Robert Byuma, Johanna Albertha Carstens, Allison Carter, Nazneen Cassim, Busisiwe Cebekhulu, Bongekile Cele, Dolly Judith Cele, Phindile Cele, Simangele Cele, Sithabile Cele, Mary Chadza, Nahida Chakhtoura, Claire Chapdu, Gift Tafadzwa Chareka, Charles Chasakara, Manju Chatani-Gada, Diana Chetty, Mary Chidanyika, Tafadzwa Tariro Lisa Chifambi, Emelder Chihota, Sungano Chikono, Anesu Chikonyora, Brett Dzidzai Chikukwa, Craig Chin, Mary Chindevu, Tendai Blessing Chinyanda, Thandiwe Hilda Chirenda, Zvavahera Mike Chirenje, Chiedza Chirisa, Patience Chisale, Angela Chishanga, Tobias Chitambo, Fred Chitema, Flora Chithila, Tinei Helen Chitowa, Catherine Chitsinde, Gladys Chitsulo, Miria Chitukuta, Spiwe Chiveso, Nelecy Chome, Phumelele Fortune Chonco, Emily Christopher, Kerusha Chunderduri, Vutomi Cibi, Naana Cleland, Thobeka Coba, Mandy Rae Cobbing, Clare Collins, Kim Comer, Shameen Cozzi, Danielle Crida, Sufia Dadabhai, Thembakazi Daki, Nwabisa Danster, Reshmi Dassaye, Renita David, Jontraye M. Davis, Sumaya Dawood, Pallabi Deb, Leslie Degnam, Tiffany Sharron Derrick, Bríd Teresa Devlin, Charlene Dezzutti, Patricia Mae Dhlakama, Lorna Dias, Jean Chivoniso Dimairo, Elaine Dinnie, Avile Dlabanta, Msizi Dladla, Thandeka Immaculate Dladla, Andile Princess Dlungele, Curtis Dolezal, Kristine Donaty, Clare Dott, Jenna Dubbs, Vuyiseka Dubula-Majola, Pamella Dukwe, Cebo Ivan Duma, Portia Ignatia Makhosazana Duma, Promise Duma, Vimbai Kudzanai Duncan, Luis Duran, Lindelwa Dyabeni, Andrew Edwards, Radhika Etikala, Juliane Etima, Lee Fairlie, Henry Fischer, Jacqueline Fitzpatrick, Llewellyn Fleurs, Mary Glenn Fowler, Lester Freeman, Zakir Gaffoor, Lizzy Gama, Anita Garg, Vanesa Margret Gatsi, Clifford Gcwensa, Emmanuel Lwandile Gebashe, Samantha Geduld, Jennipher Gelant, Donna Germuga, Joseph Ggita, Rebecca Giguere, Lucy Godo, B. Jay Goetz, Litha Gogo, Esther Goliati, Daniel Kondwani Gondwe, Kelley C. Gordon, Rodney Goreraza, Jayandree Gounden, Dhevium Govender, Justin Sivalingum Govender, Nerusha Govender, Subramonien Govender, Nonkululeko Nosipho Gqwara, Anisa (Tracy) Gravelle, Phindile Guga, Victor Guma, Delisile Zilungile Gumede, Sibusiso Gumede, Thembelihle Gumede, Thobeka Winifred Gumede, Orgrah Gundani, Ravi Gunnam, Rahul Gupta, Mirriam Gwande, Xolani Gxako, Kim Hall, Wayne Hall, Perry Hargrave, Ishana Harkoo, Tanya Harrell, Amy L. Heaps, Simone Lara Hendricks, Craig W. Hendrix, Bongeka Hlabisa, Lungile Bongeka Hlabisa, Kudzai Hlahla, Thulebona Martin Hlela, Thandiwe Hobongwana, Eva Horn, Ridley Howard, Haixiao Huang, Portia Hunidzairia, Nivriti Hurbans, Marla Husnik, Tendai Doreen Hwehwe, Rabia Imamdin, Amina Ismail, Ebrahiema Jacobs, Ashleigh Catherine Jacques, Jane Jamabya, Grace James, Karla Janse van Rensburg, Ziningi Nobuhle Jaya, Nitesha Jeenarain, Lauren Jennings, Haoping Jiang, Ning Jiang, Nwabisa Laurianne Jijana, Godfrey Jokoniya, Mildred Kabasonga, Daniel Kizza Kabenge, Samuel Kabwigu, Evans Kachale, Lonely Kachenjera, Fiona Kachingamire, Emma Kachipapa, Mary Kadiwa, McLoddy Kadyamusuma, Bosco Kafufu, Mary Mukasa Kagwa, Clare Kajura-Manyindo, Brenda Catherine Kakayi, Victoria Kaliwo, Dishiki Jenny Kalonji, Nyasha Elizabeth Kamanga, Betty Kamira, Zerif Kampangire, Getrude Kamwana, Justine Kamya, La-Donna Kapa, Patrick Karugaba, Khumbo Kasambara, Priya Kassim, Sheetal Kassim, Milly Katana, Francis Katongole, Sulaiman Katongole, Alexis Katsis, Chaplain Katumbi, Ariana W.K. Katz, Edmore Kawanje, Caroline Nassozi Kawuma, Sowedi Kayongo, Emily Kekana, Doreen Kemigisha, Siphosihle Khanyile, Nombuso Happiness Khanyisile, Babalwa Khaya, Noluthando Khiya, Norah Ntombikayise Khoza, Thembisile Khumalo, Christina Khwela, Zamo Khwela, Edith Kibiribiri, Ismael Kibirige, Beatrice Kiiza, Florence Sempa Kikonyogo, Melissa Kin, Catherine Kirkwood, Girisha Kistnasami, Flavia Matovu Kiweewa, Max Kiweewa, Deepika Konatham, Lungile Kubheka, Terrence Kufakunesu, Phaleda Kumwenda, Wiza Wisdom Isaac Kumwenda, Maura Kush, Bryan A. Kutner, Ntomboxolo Kwatsha, Rosper Kwedza, Erinah Kyomukama, Debra Lands, Phumelele Nokuthula Langa, Kalkidan Lebeta, Cody Lentz, Brendley Tebogo Leremi, Michelle Leszczewski, Lisa Levy, Ted Livant, Irene Lukas, Lungile Pearl Mabanga, Nomusa Mabaso, Vimbainashe Machisa, Toni M. Maddox, Bernadette Madlala, Nocwaka Magobiane, Melda Magolela, Fungai Maguramhinga, Phumzile Desiree Magwaza, Keshnee Maharaj, Ferial Mahed, Tankiso Vuyiswa Mahlase, Moshukutjoane Lebogang Maila, Yvonne Makala, Patrick Makamure, Kgabo Phineas Makgoka, Pamela Makhamba, Nompumelelo Makhanya, Rulani Makondo, Rujeko Makoni, Henry Makooka, Jennie Makunganya, Sibongile Makwenda, Gakiema Malan, Agnes Malemia, Mariette Malherbe, Faith Malunga, Temantfulini Mamba Nhassengo, Mogau Mampa, Tendai Karen Mamvura, Elmah Manengamambo, Loreen Zandile Mangove, Nomvuyo Thelma Mangxilana, Tsungai Patience Manjera, Winifred Elizabeth Mans, Leila Mansoor, Memory Maoko, Annie Mapfunde, Nonhlanhla Yvonne Maphumulo, Francis E.A. Martinson, Abel Maruwo, Emmerentia Yvonne Marx, Mark A. Marzinke, Moira Masango, Mmathabo Nnana Mashego, Gwendoline Thotele Refilwe Mashinini, Shingirayi Irene Masuko, Kudzai Viviana Matambanadzo, Florence Tintswalo Mathebula, Matheus Mathipa, Jacob Munyaradzi Matsa, Eleanor Agnes Matta, Allen Taguma Matubu, Ayanda Comfort Mavundla, Sandile Mavundla, Billy Mawindo, Josiah Mayani, Emmanuel Mayanja, Nombongo Mayekiso, Nonkululeko Precious Mayisela, Ashley J. Mayo, Mary Speciosa Mbabali, Nonhlakanipho Masibonge Gciniwe Mbanjwa, Constance Seanokeng Mbatha, Nomcedo Janice Mbatha, Dorica Mbewe, Tinkhani Mbichila, Yamikani Rose Mbilizi, Sithokoza Mbokazi, Mwandifitsa Mbwerera, Zethu Mchunu, Laura McKinstry, Bongiwe Mdlongwa, John W. Mellors, Sihle Perfect Meyiwa, Nyaradzo Mavis Mgodi, Erasmus Samuel Mhizha, Nomsa Sibongile Mhlanga, Brenda Gail Mirembe, Dorothy Mirembe, Fumbani Mkandawire, Ntombizethu Hazel Mkhabela, Baningi Mkhize, Princess Hlengiwe Mkhize, Zaba Mkhize, Elizabeth Gugu Mlangeni, Margaret Mlingo, Bukiwe Mngqebisa, Noluxolo Mngxekeza, Anele Mninzi, Nonzwakazi Mnqonywa, Mammekwa Mogkoro, Thembisile Wilmah Mogodiri, Rebone Frengelina Mohuba, Maseponki Cecilia Mokoena, Noxolo Mona, Deidra Montoya, Willie Monyethabeng, Jayajothi Moodley, Jeeva Moodley, Kerushini Moodley, Suri Moonsamy, Neetha Shagan Morar, Sophie Nomsa Morudu, Angela Mpekula, Gerald Thsepo Mphisa, Jayne Mpofu, Hlengiwe Theodora Mposula, Avril Mqadi, Emmie Msiska, Lusungu Msumba, Nana Mtambo, Emmanuel Sinothi Mthalane, Thabisile Susan Mthembu, Zanoxolo Mthethi, Magdeline Judith Mthethwa, Ntokozo Zabathethwa Mthethwa, Sicelo Samuel Mthimkhulu, Itsepheng Mtlokoa, Michael Charles Mubiru, Mary Mudavanhu, Anna Zvirevo Mufumisi, Agnes Mary Mugagga, Joanita Muganga, Michelle Mugava, Margaret Mugenyi, Caroline Mugocha, Faith Mugodhi, Norma Mugwagwa, Felix Godwin Sivhukile Muhlanga, Shorai Mukaka, Dick Mukasa, Restituta Mukasa, Mathews Mukatipa, Shedina Mukova, Sarah Mulebeke, Joyce Mulima, Julio Muller, Faith Mulumba, Tsitsi Mupamombe, Constance Murandu, Tarisai Murefu, Fungai Murewa, Kudakwashe Muringayi, Caroline Murombedzi, Petina Musara, Jane Nsubuga Musisi, Mary Maria Musisi, Philippa Musoke, Joseph Mutebo, Prisca Mutero, Kudzai Santana Mutiti, Shadreck Mutizira, Sharon Mutsvunguma, Netsai Muungani, Tariro Muvunzi, Rosemary Muwawu, Samkelisiwe Mvelase, Priscilla Pamela Mvinjelwa, Goodness Zoh Mvuyane, Liness Mwafulirwa, Pokiwe Mwagomba, Thoko Gift Mwakhwawa, Deborah Mwebaza, Wezi Longwe Mwenda, Nqobile Myeni, Angeline Doreen Nonhlanhla Mzolo, Regina Bukenya Nabatanzi, Joselyne Nabisere, Josephine Nabukeera, Christine Valerie Nagawa, Cherise Naicker, Kumari Naicker, Vimla Naicker, Ishana Naidoo, Jason Naidoo, Jayganthie Naidoo, Kalendri Naidoo, Renissa Naidoo, Sandy Naidoo, Nalini Naidu, Gonasagrie Lulu Nair, Susan Nakacwa, Joyce Gladys Nakakande, Rita Nakalega, Maria Gorreti Nakalema, Jesca Nakibuka, Teopista Nakyanzi, Justine Nakyeyune, Stella Nalusiba, Rhoda Namakula, Felix Namalueso, Paula Mubiru Namayanja, Christine Tapuwa Nampala, Suzan Nkalubo Nampiira, Agnes Namuddu, Norah Nandundu, Winnie Nansamba, Stella Nanyonga, Sophie Clare Nanziri, Zainab Nakivumbi Nassoma, Duduzile Ethel Ncube, Eva Ncube, Sithabile Ncube, Pepukayi Ndadziyira, Pamella Pumla Ndamase, Walter Seth Taurayi Nderecha, Zanele Ndhlovu-Forde, Thembelihle Cynthia Ndimande, Bukekile Ndlovu, Grecenia Ndlovu, James Ndlovu, Nontokozo Happiness Ndlovu, Thakisile Nontokozo Ndlovu, Zodwa Ndlovu, Margret Ndovie, Beauty Nemasango, Blazej Neradilek, Susan Ngani, Nokwanda Queeneth Ngcebethsha, Lizbon Ngcobela, Nolwazi Ngcobo, Nompumelelo Ngcobo, Sindisiwe Promise Ngcobo, Nidleka Ngcukana, Julie Ngo, Nontshukumo Ngqabe, Siyabonga Ngqame, Mduduzi Dawood Ngubane, Nancy Nokuthula Ngwenya, Mugowe Nhkoma, Bongiwe Ntombizodwa Nhlapho, Sibusiso Nhleko, Hlengiwe Nkwanyana, Heather Noble, Lumka Lucia Nobula, Monica Nolan, Mluleki Nompondwana, Busiwe Notshokovu, Vukani Sandile Ntanzi, Nishi Nursaye, Jeremy Peter Nutall, Omega Nyabadza, Evelesi Nyaka, Sandra Nyakudya, Envioletta Chiedza Nyakura, Shingayi Nyamadzawo, Tsitsi Nyamuzihwa, Zubayiri Nyanzi, Angel Tinny Nyathi, Fadire Nyirenda, Makandwe Nyirenda, Mary Nyirenda, Sinqobile Charity Nzama, Lamec Sbongisomi Nzuza, Bhavesha O'Byrne, Fabian Okello, Eunice Okumu, Emmanuel Oluka, Francis Onen, Carolyne Peris Onyango, Katherine Ostbye, Kerusha Padayachee, Victor Palichina, Zhenyu Pan, Colin Pappajohn, Levanya Paramanund, Urvi M. Parikh, Nazmie Pearce, Kerri J. Penrose, Bathandekile Molly Phahlamohlaka, Nokulunga Ruth Phidane, Omisha Pillay, Anamika Premrajh, Nikita Prosad, Lorna Rabe, Alishka Rajman, Keneoe Maphuti Rampai, Hlalifi Sylvia Rampyapedi, April Randhawa, Sabelo Rasmeni, Dianne Rausch, Avanita Reddy, Isayum Reddy, Jerusha Reddy, Krishnaveni Reddy, Vera Helen Rees, Andrea Repetto, Cheryl Richards, Sharon Riddler, Nobubele Rini, Brendon Roeber, Lisa Rohan, Zachary Romer, Matthew Rose, Zeda Fran Rosenberg, Lisa Rossi, Aviva Ruch, Christine Rullo, Sinazo Runeyi, Olivia Rupemba, Chenai Rushwaya, Marisa Russell, Patience Sharai Ruzive, Godfrey Rwanzogyera, Margaret Nakato Saava, Tshepo Jimmy Sagela, Rebecca Sakwa, Fathima Sayed, Jennifer Schille, Nokwayintombi Scotch, William Scott, Caitlin Scoville, Richard Sebagala, Elaine Sebastian, Natasha Tina Sedze, Nasreen Hoosen Seedat, Joseph Semakula, Teri Senn, Francis Serugo, Linly Seyama, Bhekanani Khumulani Shabalala, Charlotte Phumzile Shangase, Pamela Caroline Shanhinga, Jeremy Shaver, Hanjie Shen, Mogobalale Corlett Shogole, Rachel Shonhiwa, Claudia Shozi, Marvelous Sibanda, Sylvia Sibongile Sibeko, Ncamisile Teressa Sibisi, Samuel Siphelele Sibisi, Brighty Zweni Sibiya, Happiness Sibiya, Dorothy Sichali, Phumzile Yvonne Sikosana, Craig Silva, Ayanda Purity Simelane, Melissa Simon, Triesha Sing, Hailey Virginia Sithole, Edith Sitima, Alex Siyasiya, Vuyane Sizane, Bekezela Siziba, Edward Slezinger, Daria Smolinski, Katie Snapinn, Olwethu Sogoni, Dean Soko, Leonard Nichiren Solai, Mandiphumle Somga, Mei Song, Xiaoling Song, Devarani Soobryan, Lydia Soto-Torres, Patrick Lawrence Spence, Elizabeth Spooner, Vincent Sseguya, Augustine Ssentongo, Mark Ssenyonga, Lawrence Lollian Sseremba, Michael Stais, John Steytler, Sharon Stockton, Julie Stofel, Tinyiko Reginah Stuurman, Sizakele Sukazi, Jasmin Lynn Sukdao, Kranthi Swarna, Daniel Szydlo, Christine Tagliaferri Rael, Dorothy Rumbidzai Taguta, Taha Taha, Eunice Tahuringana, Joshua Tamale, Penelope Tambama, Edna Taulo, Frank Taulo, Thelma Tonderai Tauya, Gerald Tegha, Sindisiwe Lucia Tembe, Tchangani Tembo, Constance Lebo Thatelo, Pinky Mery Thobela, Annie Thom, Christine Thompson, Monica Thompson, Linda Thusi, Lauri Tock, Thandokazi Tofile, Carol Tranfaglia, Jenny Tseng, Themba Tshabalala, Nomvuselelo Tshongoyi, Mercy Tsidya, Wendy Rufaro Tsikiwa, NoCamagu Tuswa-Haynes, Bomkazi Onini Tutshana, Andile Premrose Twala, Ashvir Viren Udith, Christine Unten, Neliette van Niekerk, Amanda Varela, Nangamso Vatsha, Gayathri Vijayendran, Amukelani California Vuma, Deo Ogema Wabwire, Madalo Walani, Bhekisisa Wanda, Lisa Wasberg, Rhonda R. White, Kathleen Marie Windle, Kubashni Woeber, Danica Wright, Tiffanee Wright, Thembalethu Nontokozo Xaba, Makanaka Jean Savie Yambira, Ntando Yola, Sindisiwe Lydia Zaca, Aisha Zalwango, Jullian Zemanek, Chifundo Zimba, Tsitsi Zinyengere, Margaret Zinyongo, Thabile Goodness Zondi, Chun Zou, Jabulisile Zuma, Nokuthula Princess Zungu, and Nompumelelo Zungu

Subjects
0301 basic medicine, Adult, Zimbabwe, medicine.medical_specialty, Malawi, Epidemiology, Anti-HIV Agents, Immunology, Dapivirine, HIV Infections, Placebo, Article, 03 medical and health sciences, South Africa, 0302 clinical medicine, Virology, Internal medicine, Microbicide, medicine, Humans, Uganda, 030212 general & internal medicine, Tenofovir, business.industry, Surrogate endpoint, Incidence (epidemiology), Contraceptive Devices, Female, 030112 virology, Vaginal ring, Clinical trial, Administration, Intravaginal, Infectious Diseases, Clinical research, Pyrimidines, Treatment Outcome, Seroconversion, HIV-1, Patient Compliance, Female, Patient Safety, business
Abstract

Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.We did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.Between July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR.High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa.The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.

Published
2020

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