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1. Simplified Criteria to Assess Long-Term Antiviral Treatment Indication in Chronic HBV-Infected Pregnant Women in Cambodia

Author

Jee-Seon Yang, Saren Sovann, Yusuke Shimakawa, Sovann Nhoueng, Bunnet Dim, Chanlina Vong, Channa Sann, Julia Guillebaud, Darapolin Vann, Bunrith Touch, Hyna Chea, Wathanak Pisey Choupoan Phirum, Eric Rosenthal, Christelle Paul, Leangchhun Khun, Chantana Yay, Denis Laurent, Samsorphea Chhun, Laurence Borand, and Olivier Segeral

Subjects
hepatitis B, pregnancy, postpartum, long-term treatment, public health, international guidelines, Microbiology, QR1-502
Abstract

Pregnant women identified to carry hepatitis B surface antigen (HBsAg) should be linked to care for the determination of the need for long-term antiviral therapy (LTT). We assessed the performance of simplified criteria, free from HBV DNA quantification, to select women eligible for LTT using different international guidelines as a reference. A retrospective analysis of HBV-infected pregnant women enrolled in the phase 4 ANRS TA-PROHM study was conducted in Cambodia. Sensitivity, specificity, and AUROC were computed to compare three simplified criteria (TREAT-B, HBcrAg/ALT, and TA-PROHM) with the American (AASLD) and European (EASL) guidelines as a reference. An additional assessment was performed at 6 months postpartum. Of 651 HBsAg-positive women, 209 (32%) received peripartum antiviral prophylaxis using tenofovir disoproxil fumarate (TDF). During pregnancy, 9% and 12% of women were eligible for LTT according to AASLD and EASL guidelines, respectively; 21% and 24% of women were eligible for prophylactic TDF and 2% and 5% in those ineligible (p < 0.001). Using the AASLD guidelines, the AUROC of TREAT-B, HBcrAg/ALT, and TA-PROHM scores were 0.88 (95%CI, 0.85–0.90), 0.90 (95%CI, 0.87–0.92), and 0.76 (95%CI, 0.73–0.80), respectively. Using the EASL guidelines, the AUROCs were lower: 0.73 (95%CI, 0.69–0.76), 0.76 (95%CI, 0.73–0.80), and 0.71 (95%CI, 0.67–0.74), respectively. Among those ineligible for prophylactic TDF, only 2% to 6% present an indication for LTT at 24 weeks postpartum. Few pregnant women are eligible for LTT, and the use of simplified criteria could represent an efficient triage option in decentralized areas to identify those negative for whom there is no urgent indication for LTT and focus on those positive for whom other exams must be conducted to confirm LTT indication.

Published
2024
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2. Effect of decentralising childhood tuberculosis diagnosis to primary health centre versus district hospital levels on disease detection in children from six high tuberculosis incidence countries: an operational research, pre-post intervention study

Author

Laurence, Borand, Agathe, de Lauzanne, Bunnet, Dim, Seyla, Heang, Sanary, Kaing, Chanty, Keang, Socheat, L.Y., Pichpiseth, Meas, Sovann, Nhoueng, Long, Pring, Vouchleang, Sreng, Song, Yin, Saren, Sovan, Chanvirak, Phan, Chanra, Chreng, Ratha, Khoun, Monicando, Rin, Sophea, Pal, Boraneath, Nang, Rathakrun, Pom, Tan Eang, Mao, Simoy, Chhim, Huot, Touch, Kosal, Suon, Saronn, Chum, Kimhong, Tok, Kimchorn, Pring, Satya, Krouch, Chean, Chok, Sunleng, Seun, Savtey, Phon, Mai, Nang, Kimda, Hun, Vanny, Hong, Dara, Sok, Kosal, Chea, Bunthoeun, Chheang, Rino, Sem, Lam, Lay, Haysan, Say, Pholly, Kem, Sreyphal, Meng, Sokheng, Phorn, Sreyvann, Him, Peakdey, Pheach, Dalai, Kive, Moeur, Sar, Sreydy, Kong, Seyha, Kong, Sreytouch, Yorn, Soam, Tes, Sophal, Kep, Seroeung HENG Thy, Leng, Savorn, Neak, Sim, Seng, Pheakna, Pay, Sithan, Suon, Sophanna, Chan, Dyna, Um, Savuth, Sin, Sam, Phan, Sarim, Kum, Sokheng, Khath, Pong, Phem, Seyha, Sok, Chanty, Ny, Van, Leim, Sereyvuth, Pich, Sengkry, Chheang, Nhin, Eang, Vannareth, Sao, Vannak, Sim, Sopheak, Som, Ney, Pong, Sokha, Van, Sreyleap, Seng, Vanna, Yoeurng, Kakada, Toem, Thida, Keo, Vuochny, Sem, Sophal, Veng, Chanthol, Rin, Vanny, Seang, Kiri, Lok, Khemra, Mao, Keovanna, Ouk, Maiya, Min, Suomun, Morm, Rattana, Koy, Sreypov, Chhann, Sreytouch, Set, Audrey, Amboua Schouame, Clifford, Babey, Masama, Eden Ngu, Etienne, Guenou, Sylvie, Kwedi Nolna, Douglas, Mbang Massom, Bernard Fortune, Melingui, Nadia, Nga Elomo, Moïse, Mvetumbo, Angeline, Nkembe, Krystel, Ebo, Albert, Kuate Kuate, Michelline, Choupa, Maggi, Mbede, Valerie, Donkeng, Nelly, Kamgaing, Jean-Voisin, Taguebue, Achille, Touha Yannick, Estelle, Abomo Zang, Rosette, Bakoa, Esperance, Mimbouombela Leger, Sabine, Eleme, Gabrielle, Eteme Marie, Thierry, Elouna Nkoa, Dieudonné, Ndzana, Christophe, Bitti, Olivier, Fotsing, Charlotte, Lani Boko, Mathieu, Mbonga, Ghislain Ulrich, Njakou Sagang, Innocent, Onomo, Charlotte, Essaga Hortense, Daniel Desiré, Mboudi Kouang, Léon, Eloundou, Helene, Kengne, Felix, Mbassi, Juliette, Bidjeme, Hortense, Toua Eteme, Nadege, Essama, Roger, Belinga Balla, Norbert, Tassi, Roline, Nguiko Elsa, Leonard, Mekongo, Fabien, Eyebe Ayissi, Francine Christelle, Biloa Anaba, Philomène, Nsom, Celestin Géraud, Yam Essola, Edwige Léa, Mame Moo, Noé, Makon, Arllette Rita, Nounkep Yanghu, Frank, Ebanga, Antoinette, Assiga Ntsama, Carlyle Sorelle, Kamguia Djuimsop, Diane, Mbabou, Marie, Maguip Abanda, Rosine Berthe, Nguemafouo Doummene, Amos, Mekone, Ngwankfu, Konfor Blessing, Jérome, Mimboe, Virginie, Tiona, Roland, Beleck, Sairou, Zam, Nicole, Adibone, Claude, Biaback Jean, Denis, Bessong, Gilbert, Aminou, Jeremie Pagnol, Bille Bonga, Aubin, Fotso Monkap, Epse NGON Annie, Hitekelek, Vitrice, Sebe, Leo, Makon, Marie, Ennah, Mpie, Paul Boyolo, Diane Viviane, Metchoum, Celin, Nzambe, Arnaud, Dado, Milobert, Mbengang, Marceline, Eyebi, Vanessa, Ngah, Alice, Mballa Batonga, Solange, Ayouba, Pierrette, Ebode, Majino, Mamou, Marguerite, Botomogne Bomba, Salametou, Ngnet, Augustine Florence, Essengue Ngono, Rolland, Odionoloba Charles, Bernice, Bisso, Suzy, Balemaken Ingrid, Marie Louise, Mandoki a Bilong, Gertrude, Ndeng Ayouba, Josue, Ngon, Roger, Aka Bony, Kacou Michel, Bah, Dro, Bakayoko, Rolande, Baki Aimee, Marie-France Larissa, Banga, Olivier, Bouzié, Kan, Brou, Pan, Coulibaly, Serge, Danho, Flavien, Deli, Alphonse, Dion, Bi, Do, Armand, Dohoun, William, Edjeme, Cathérine, Falé, Melissa, Gogoua Saulé, Constant, Kesse, Eric, Komena Auguste, Christian, Kouadio, Arkason, Kouame Abel, Raoul, Moh, Sandrine, Nguessan Marcelle, Bertine, Siloué, Nina, Soua, Cyrille Prisca, Yao Yapi, Timothée, Ouassa, Jacquemin, Kouakou, Eric, Balestre, Aurélie, Beuscart, Aurélie, Charpin, Marc, D'elbee, Hélène, Font, Basant, Joshi, Nicolas, Koskas, Olivier, Marcy, Estelle, Occelli, Joanna, Orne-Gliemann, Julien, Poublan, Elodie, Vernoux, Maryline, Bonnet, Savine, Chauvet, Manon, Lounnas, Guillaume, Breton, Pierre-Yves, Norval, Sheyla, Cassy, Verna, Chambal, Valter, Chiúle, Supinho, Chimbanje, Saniata, Cumbe, Mércia, Matsinhe, Celso, Khosa, Nairo, Mabote, Salvador, Machava, Emelva, Machonisse, Verónica, Macuácua, Denise, Milice, Jorge, Ribeiro, Elcídio, Tivane, Dorlim, Uetela, Yara, Voss de Lima, Américo, Zandamela, Alcina, Zita, Ivan, Manhiça, Benedita, José, Dalila, Rego, Chris, Buck W., Kapoli, Kasembe, Atália, Massangaie, Assa, Sitoe, Ambostique, Argola, Césio, Miambo, Presequila, Nhatsave, Gilda, Sitoe, Charifito, Vesta, Salvador, Dimande, Lázaro, Mazembe, Nilza, Amade, Manuela, Chavela, Nomsa, Macheque, Salomão, Comé, Eulália, Machava, Narciso, Mucavele, Jacinto, Nhabanga, Marlene, Nicolau, Natércia, Simbine, Lina, Uendela, Micaela, Juaio, Abiba, Saíde, Naira, Macie, Fernando, Mondlane, Stélio, Simango, Prince, Beyan, Benjamin M, Flomo, Abubakarr, Jalloh Joseph, Ishmael, Kamara, Monica G, Koroma, Mohamed, Lamin, Lena, Matata, Ross, Mugisha Jacob, Christiana M, Senesie, Sheriff, S.E.S.A.Y., Egerton, Tamba Kamara, Ayeshatu, Mustapha, Lynda, Foray, Sandra, Agondeze, Agnes, Kobusingye, Mastula, Nanfuka, Faith, Namulinda, Eric, Wobudeya, Rinah, Arinaitwe, Rodney, Kaitano, Martin, Kasujja, Juliet, Mwanga-Amumpaire, Evans, Mwesigwa, Naome, Natukunda, Simpson, Nuwamanya, Miria, Nyangoma, Patrick, Orikiriza, Johnbosco, Tumwijukye, Esther, Turyashemererwa, Nyehangane, Dan, Mugisha, Ivan, Winnie, Biryeri, George, Naika, Robert, Ongwara O., Allen, Najjuko, Augustine, Kayiira, Samuel, Yairo, Immaculate, Tumwebaze, Goreth, Nalwoga, Paul, Nsiyaleta, Annet, Agaba, Martin, Mpimbaza M., Norbert, Akampurira, Agatha, Tugumisirize, Evans, Ariyo, Julius, Agaba, Yovita, Natukunda, Nelson, Musazi, Edmund, Musinguzi, Brown, Baluku Julius, Moorine, Sekadde, Stavia, Turyahabwe, Chishala, Chabala, Luis, Cuevas, Christophe, Delacourt, Steve, Graham, Malgorzata, Grzemska, Sabine, Verkuijl, Anneke, Hesseling, Elizabeth, Maleche-Obimbo, Mark, Nicol, Wobudeya, Eric, Nanfuka, Mastula, Ton Nu Nguyet, Minh Huyen, Taguebue, Jean-Voisin, Moh, Raoul, Breton, Guillaume, Khosa, Celso, Borand, Laurence, Mwanga-Amumpaire, Juliet, Mustapha, Ayeshatu, Nolna, Sylvie Kwedi, Komena, Eric, Mugisha, Jacob Ross, Natukunda, Naome, Dim, Bunnet, de Lauzanne, Agathe, Cumbe, Saniata, Balestre, Eric, Poublan, Julien, Lounnas, Manon, Ngu, Eden, Joshi, Basant, Norval, Pierre-Yves, Terquiem, Etienne Leroy, Turyahabwe, Stavia, Foray, Lynda, Sidibé, Souleymane, Manhiça, Ivan, Sekadde, Moorine, Detjen, Anne, Verkuijl, Sabine, Mao, Tan Eang, Orne-Gliemann, Joanna, Bonnet, Maryline, and Marcy, Olivier

Published
2024
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3. Immunoglobulin-free strategy to prevent HBV mother-to-child transmission in Cambodia (TA-PROHM): a single-arm, multicentre, phase 4 trial

Author

Olivier Segeral, Bunnet Dim, Christine Durier, Sovann Nhoueng, Kearena Chhim, Saren Sovann, Sophal Yom, Chanlina Vong, Song Yin, Bandith Ros, Vutha Ky, Sothy Pech, Bunthoeun Nem, Kay Hout, Julia Guillebaud, Eamkim Ear, Layana Caroupaye-Caroupin, Claire Rekacewicz, Laura Fernandez, Denis Laurent, Chantana Yay, Rattana Kim, Laurence Meyer, Samsorphea Chhun, Chanthy Keang, Ousa Khan, Boraneath Nang, Vouch Leang Sreng, Sopheavet In, Sineath Sun, Linda Sov, Bunrachana Nor, Brembrey Hing, Sokkim Seng, Sophea Soum, Leakhena Say, Sao Sarady Ay, Daneth Thol, Chhorn Chhouk, Patrice Piola, Janin Nouhin, Anne-Marie Roque Afonso, Jean Charles Duclos Vallee, Channa Sann, Leang Sim Kruy, Maud Lemoine, Laurent Mandelbrot, Stephane Blanche, Alpha Diallo, Christelle Paul, SAY Tiv, Polinn Sar, Lyvoin Nov, Darapoline Vann, Tha Chea, Bunrith Touch, Kongkea Neav, Ekvitou Kong, Ratha Chea, Chanksolina Ouk, Lyhour Meak, Rayounette Krouch, Naneth Chhan, Sody Seang, Veasna Nuon, Leang Meng, Sok Leakhena Tharith, Sovannara Hang, Vanrithy Som, Rithy Som, Phirak Seng, Malys Lim, Kimchhorn Srey, Sok Rothavy Uch, Pichthyda Hou, Satha Bo, Eanghor Ieang, Kimchhorng Korn, Chan Reatrey Noun, Sokhoeun Soy, Thou Khim, Vutha Sou, Sokha Pol, Samreth Nget, Marina Sun, Phearom Uon, Kim Teng Ya, Kimsreng Lean, Kim Ean Eang, Sophal Ung, Rauin Rith, Charya Mom, Chanthea Keang, Soklyda Sam, Sokneth Chuong, Chanmony Nam, Sophya Khuon, Sidet Cheang, Sopheak Lean, Arnaud Tarantola, Isabelle Fournier, Nicolas Rouveau, and Maria-Camila Calvo cortez

Subjects
Hepatitis B virus, Hepatitis B Surface Antigens, Infant, Newborn, Alanine Transaminase, Viral Load, Hepatitis B, Antiviral Agents, Infectious Disease Transmission, Vertical, Infectious Diseases, Pregnancy, DNA, Viral, Humans, Female, Hepatitis B e Antigens, Cambodia, Tenofovir
Abstract

Prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) is based on administration of vaccine and immunoglobulins (HBIg) to newborns at birth and maternal antiviral prophylaxis for those with an HBV-DNA viral load of at 5·3 logTA-PROHM was a single-arm, multicentre, phase 4 trial done in five maternity units in Cambodia. Pregnant women who were positive for hepatitis B surface antigen (HBsAg), aged 18 years or older were included. Women who were HCV or HIV positive, had creatinine clearance of less than 30 mL/min, severe gravid disease, and planned to give birth outside the study sites were excluded. From Oct 4, 2017, to Jan 9, 2019, HBsAg positive pregnant women who tested positive for hepatitis B e antigen (HBeAg) with a rapid diagnostic test were eligible to receive tenofovir disoproxil fumarate. From Jan 9, 2019, women who were HBeAg negative with an alanine aminotransferase concentration of ≥40 IU/L were also eligible to receive tenofovir disoproxil fumarate. Women in the tenofovir disoproxil fumarate eligible group received 300 mg of tenofovir disoproxil fumarate orally once a day from the 24th week of gestation until 6 weeks postpartum. The primary outcome was the overall proportion of infants who were HBsAg positive at 6 months of life, confirmed by positive HBV DNA quantification. For the primary outcome, the proportion (95% CI) of infants with HBsAg at 6 months was stratified according to infant's HBIg status, duration of maternal tenofovir disoproxil fumarate treatment (4 weeks and ≤4 weeks), and study period (before and after the change in therapeutic algorithm) and was measured in a modified intention-to-treat analysis, which excluded infants lost to follow-up or who were withdrawn before 6 months. The study is registered with ClinicalTrials.gov, NCT02937779.From Oct 4, 2017, to Nov 27, 2020, 21 251 pregnant women were screened for HBsAg, of whom 1194 (6%) were enrolled in the study: 338 (28%) were eligible to receive tenofovir disoproxil fumarate. For the tenofovir disoproxil fumarate eligible group, four (1% [95% CI 0·34-3·20]) of 317 infants had HBV infection at 6 months; in the subgroup of 271 children who did not receive HBIg, four (1% [0·40-3·74]) had HBV infection at 6 months. In absence of HBIg, MTCT HBV transmission occurred in none (0% [0-1·61]) of 227 women who received tenofovir disoproxil fumarate for more than 4 weeks before giving birth and three (8% [1·75-22·47]) of 36 women who received tenofovir disoproxil fumarate for less than 4 weeks. In the tenofovir disoproxil fumarate ineligible group, seven (1% [0·40-2·02]) of 712 infants had HBV infection at 6 months; in the subgroup of 567 children who did not receive HBIg, six (1% [0·39-2·30]) had HBV infection at 6 months.An immunoglobulin-free strategy using an HBeAg rapid diagnosis test and alanine aminotransferase-based algorithm to assess eligibility for tenofovir, is effective at preventing MTCT of HBV when tenofovir was initiated at least 4 weeks before birth.French Agency for Research on AIDS and Viral Hepatitis and Emerging Infectious diseases.For the French translation of the abstract see Supplementary Materials section.

Published
2021

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