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3. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, Lockman, Shahin, Best, Brookie M, Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A, Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D, Ponatshego, Ponego L, Tirelo, Lesedi, Seme, Boitshepo J, Modise, Georginah O, Raesi, Mpho S, Budu, Marian E, Ramogodiri, Moakanyi, Oliveira, Ricardo H, Hofe, Cristina B, de Abreu, Thalita Fernandes, Pestanha, Lorena M, João, Esaú, Sidi, Leon C, Fuller, Trevon, Cruz, Maria LS, Pinto, Jorge, Ferreira, Flãvia, Correa, Mãrio, Romeiro, Juliana, Pilotto, Jose H, Fernandes, Luis EBC, Moreira, Luiz F, Gomes, Ivete M, Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R, Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C, Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, and Mitchell, Charles D

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Mental Health, Infectious Diseases, Pediatric, HIV/AIDS, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Infection, Good Health and Well Being, Pregnancy, Child, Female, Humans, Male, HIV Infections, Anti-HIV Agents, Tenofovir, Benzoxazines, Emtricitabine, Adenine, RNA, Viral Load, IMPAACT 2010/VESTED Study Team and Investigators, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundDrugs taken during pregnancy can affect maternal and child health outcomes, but few studies have compared the safety and virological efficacy of different antiretroviral therapy (ART) regimens. We report the primary safety outcomes from enrolment up to 50 weeks post partum and a secondary virological efficacy outcome at 50 weeks post partum of three commonly used ART regimens for HIV-1.MethodsIn this multicentre, open-label, randomised, controlled, phase 3 trial, we enrolled pregnant women aged 18 years or older with confirmed HIV-1 infection at 14-28 weeks of gestation. Women were enrolled at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Participants were randomly assigned (1:1:1) to one of three oral regimens: dolutegravir, emtricitabine, and tenofovir alafenamide; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; or efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Up to 14 days of antepartum ART before enrolment was permitted. Women with known multiple gestation, fetal anomalies, acute significant illness, transaminases more than 2·5 times the upper limit of normal, or estimated creatinine clearance of less than 60 mL/min were excluded. Primary safety analyses were pairwise comparisons between ART regimens of the proportion of maternal and infant adverse events of grade 3 or higher up to 50 weeks post partum. Secondary efficacy analyses at 50 weeks post partum included a comparison of the proportion of women with plasma HIV-1 RNA of less than 200 copies per mL in the combined dolutegravir-containing groups versus the efavirenz-containing group. Analyses were done in the intention-to-treat population, which included all randomly assigned participants with available data. This trial was registered with ClinicalTrials.gov, NCT03048422.FindingsBetween Jan 19, 2018, and Feb 8, 2019, we randomly assigned 643 pregnant women to the dolutegravir, emtricitabine, and tenofovir alafenamide group (n=217), the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group (n=215), and the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (n=211). At enrolment, median gestational age was 21·9 weeks (IQR 18·3-25·3), median CD4 count was 466 cells per μL (308-624), and median HIV-1 RNA was 903 copies per mL (152-5183). 607 (94%) women and 566 (92%) of 617 liveborn infants completed the study. Up to the week 50 post-partum visit, the estimated probability of experiencing an adverse event of grade 3 or higher was 25% in the dolutegravir, emtricitabine, and tenofovir alafenamide group; 31% in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group; and 28% in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (no significant difference between groups). Among infants, the estimated probability of experiencing at least one adverse event of grade 3 or higher by postnatal week 50 was 28% overall, with small and non-statistically significant differences between groups. By postnatal week 50, 14 infants whose mothers were in the efavirenz-containing group (7%) died, compared with six in the combined dolutegravir groups (1%). 573 (89%) women had HIV-1 RNA data available at 50 weeks post partum: 366 (96%) in the dolutegravir-containing groups and 186 (96%) in the efavirenz-containing group had HIV-1 RNA less than 200 copies per mL, with no significant difference between groups.InterpretationSafety and efficacy data during pregnancy and up to 50 weeks post partum support the current recommendation of dolutegravir-based ART (particularly in combination with emtricitabine and tenofovir alafenamide) rather than efavirenz, emtricitabine, and tenofovir disoproxil fumarate, when started in pregnancy.FundingNational 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.

Published
2023

4. Survival of Children Living with HIV/AIDS: A Multicentric Study from India

Author

Sinha, Sanjeev, Bansal, Garima, Samad, Sameer Abdul, Ajayababu, Anuj, Lal, Bhavesh Mohan, Kabra, S. K., Lodha, Rakesh, Sangle, Shashikala A., Guha, Subhasish Kamal, Rajput, Neetu, Pandey, R. M., Ranjan, Sanjay, Salvi, Sonali, Mundhe, Sanjay, More, Monika, Modak, Dolanchampa, Datta, Kalpana, Das, Bimal K., and Kinikar, Aarti

Published
2023
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5. Randomized Clinical Trial of High-Dose Rifampicin With or Without Levofloxacin Versus Standard of Care for Pediatric Tuberculous Meningitis: The TBM-KIDS Trial

Author

Paradkar, Mandar S, D, Bella Devaleenal, Mvalo, Tisungane, Arenivas, Ana, Thakur, Kiran T, Wolf, Lisa, Nimkar, Smita, Inamdar, Sadaf, Giridharan, Prathiksha, Selladurai, Elilarasi, Kinikar, Aarti, Valvi, Chhaya, Khwaja, Saltanat, Gadama, Daphne, Balaji, Sarath, Kattagoni, Krishna Yadav, Venkatesan, Mythily, Savic, Radojka, Swaminathan, Soumya, Gupta, Amita, Gupte, Nikhil, Mave, Vidya, Dooley, Kelly E, Agiwal, Shivali, Ahire, Rupali, Balasubramanian, Usha, Bendre, Manjushree, Chandane, Jyoti, Chopade, Kavita, Dalimbkar, Shamala, Deshpande, Prasad, Dhage, Rajendra, Ithape, Mahesh, Jadhav, Varsha, Kante, Sonali, Kapre, Pallavi, Khan, Nawshaba, Kulkarni, Vandana, Madewar, Renu, Meshram, Shashibhushan, Muttha, Kunal, Nadgeri, Vaishali, Nagargoje, Arti, Nagraj, Amita, Nijampurkar, Aparna, Onawale, Prerana, Pawar, Namrata, Pawar, Prashant, Pradhan, Neeta, Shaikh, Varsha, Shaikh, Zaheda, Shere, Dhananjay, Wani, Gouri, Kulkarni, Rajesh, Rajput, Uday, Ganesan, Mangalambal, Arasan, Gunasundari, Shankar, Shakila, Mary, S Stella, Karuppaiah, Sureshwari, Pauline, Leema, Pramila, Snegha Karunakaran, Arul, Priyadharshini, Ganesh, Sankar, Hanna, Luke Elizabeth, Ramesh, K, Kannan, M, Vijayakumar, Ruthra, Sivakumar, Surekha S, Devika, K, Radhakrishnan, A, Preethi, AR, Rajkumar, S, Saravanan, N, Ramachandran, Geetha, Kumar, AK Hemanth, Dharman, M, Sudha, V, Hissar, Syed, Nagarajan, Valarmathi, Jennifer, Linda, Supriya, R, Manimegalai, R, Kandan, Santhanam, Maniselvi, Archana, Puspha, Oli, Vaishnavi, S, Selvi, R, Neelakandan, Logeswari, Chiunda, Mary, Chunga, Moreen, Kamanga, Madalo, Kamthunzi, Portia, Kanthiti, Elizabeth, Mbewe, Abineli, Msiska, Emmie, Mumba, Noel, Phiri, Ian Zifa, Palichina, Victor, and Sichali, Dorothy

Subjects
Pediatric, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Child, Humans, Rifampin, Tuberculosis, Meningeal, Levofloxacin, Ethambutol, Antitubercular Agents, Standard of Care, pediatric tuberculous meningitis, neuropsychological, clinical trial, levofloxacin, high-dose rifampicin, TuBerculous Meningitis in Kids (TBM-KIDS) Study Team, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundPediatric tuberculous meningitis (TBM) commonly causes death or disability. In adults, high-dose rifampicin may reduce mortality. The role of fluoroquinolones remains unclear. There have been no antimicrobial treatment trials for pediatric TBM.MethodsTBM-KIDS was a phase 2 open-label randomized trial among children with TBM in India and Malawi. Participants received isoniazid and pyrazinamide plus: (i) high-dose rifampicin (30 mg/kg) and ethambutol (R30HZE, arm 1); (ii) high-dose rifampicin and levofloxacin (R30HZL, arm 2); or (iii) standard-dose rifampicin and ethambutol (R15HZE, arm 3) for 8 weeks, followed by 10 months of standard treatment. Functional and neurocognitive outcomes were measured longitudinally using Modified Rankin Scale (MRS) and Mullen Scales of Early Learning (MSEL).ResultsOf 2487 children prescreened, 79 were screened and 37 enrolled. Median age was 72 months; 49%, 43%, and 8% had stage I, II, and III disease, respectively. Grade 3 or higher adverse events occurred in 58%, 55%, and 36% of children in arms 1, 2, and 3, with 1 death (arm 1) and 6 early treatment discontinuations (4 in arm 1, 1 each in arms 2 and 3). By week 8, all children recovered to MRS score of 0 or 1. Average MSEL scores were significantly better in arm 1 than arm 3 in fine motor, receptive language, and expressive language domains (P

Published
2022

6. Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial

Author

Dadabhai, Sufia, Chou, Victoria B., Pinilla, Mauricio, Chinula, Lameck, Owor, Maxensia, Violari, Avy, Moodley, Dhayendre, Stranix-Chibanda, Lynda, Matubu, Taguma Allen, Chareka, Gift Tafadzwa, Theron, Gerhard, Kinikar, Aarti Avinash, Mubiana-Mbewe, Mwangelwa, Fairlie, Lee, Bobat, Raziya, Mmbaga, Blandina Theophil, Flynn, Patricia M., Taha, Taha E., McCarthy, Katie S., Browning, Renee, Mofenson, Lynne M., Brummel, Sean S., and Fowler, Mary Glenn

Published
2024
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9. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Best, Brookie M., Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A., Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D., Ponatshego, Ponego L., Tirelo, Lesedi, Seme, Boitshepo J., Modise, Georginah O., Raesi, Mpho S., Budu, Marian E., Ramogodiri, Moakanyi, Oliveira, Ricardo H., Hofe, Cristina B, Fernandes de Abreu, Thalita, Pestanha, Lorena M., João, Esaú, Sidi, Leon C., Fuller, Trevon, Cruz, Maria L.S, Pinto, Jorge, Ferreira, Flãvia, Correa Jr, Mãrio, Romeiro, Juliana, Pilotto, Jose H., Fernandes, Luis E.B.C, Moreira, Luiz F., Gomes, Ivete M., Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R., Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C., Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R., Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, Mitchell, Charles D., Drada, Adriana, Alvarez, Grace A., Scott, Gwendolyn B., Rathore, Mobeen, Mahmoudi, Saniyyah, Shabbir, Adnan, Maraqa, Nizar, Mandima, Patricia F., Mutambanengwe, Mercy, Maonera, Suzen, Chareka, Gift, Nematadzira, Teacler, Chanaiwa, Vongai, Matubu, Taguma A., Tamirepi, Kevin, Maturure, Sukunena, Mhembere, Tsungai, Vhembo, Tichaona, Chidemo, Tinashe, Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, and Lockman, Shahin

Published
2023
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10. Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis

Author

Hamada, Yohhei, Gupta, Rishi K., Quartagno, Matteo, Izzard, Abbie, Acuna-Villaorduna, Carlos, Altet, Neus, Diel, Roland, Dominguez, Jose, Floyd, Sian, Gupta, Amita, Huerga, Helena, Jones-López, Edward C., Kinikar, Aarti, Lange, Christoph, van Leth, Frank, Liu, Qiao, Lu, Wei, Lu, Peng, Rueda, Irene Latorre, Martinez, Leonardo, Mbandi, Stanley Kimbung, Muñoz, Laura, Padilla, Elisabeth Sánchez, Paradkar, Mandar, Scriba, Thomas, Sester, Martina, Shanaube, Kwame, Sharma, Surendra K., Sloot, Rosa, Sotgiu, Giovanni, Thiruvengadam, Kannan, Vashishtha, Richa, Abubakar, Ibrahim, and Rangaka, Molebogeng X.

Published
2023
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11. Inadequate Lopinavir Concentrations With Modified 8-Hourly Lopinavir/Ritonavir 4: 1 Dosing During Rifampicin-based Tuberculosis Treatment in Children Living With HIV

Author

Chabala, Chishala, Turkova, Anna, Kapasa, Monica, LeBeau, Kristen, Tembo, Chimuka H., Zimba, Kevin, Weisner, Lubbe, Zyambo, Khozya, Choo, Louise, Chungu, Chalilwe, Lungu, Joyce, Mulenga, Veronica, Crook, Angela, Gibb, Diana, McIlleron, Helen, Gibb, Diana M., Turkova, Anna, Crook, Angela M., Choo, Louise, Wills, Genevieve, Thomason, Margaret J., Teera, Jaqueline, Owen- Powell, Ellen, LeBeau, Kristen, Baptiste, David, McGowan, Charlotte, Spyer, Moira, Chabala, Chishala, Mulenga, Veronica, Lungu, Joyce, Kapasa, Monica, Zimba, Kevin, Zyambo, Khozya, Chungu, Chalilwe, Tembo, Chimuka, Kunda, Sharon, Shingalili, Ellen, Zulu, Semy, Chipoya, Terence, Mwanakalanga, Habulembe, Chambela, Elias, Hankombo, Jessy M., Kalumbi, Mox Malama, Chola, Daniel, Malama, Stephen, Wobudeya, Eric, Musoke, Philippa, Baldwin, Mboizi Robert, Nansamba, Winnie, Ssenyonga, Mark, Ssengooba, Willy, Businge, Gerald, Hesseling, Anneke C., Palmer, Megan, van der Zalm, Marieke M., Workman, Jessica, Demers, Anne-Marie, Schaaf, Simon, Gie, Robert, Walters, Elisabetta, Zimri, Warren, Hoddinott, Graeme, Deventer, Anneen van, Goussard, Pierre, Morrison, Julie, Mave, Vidya, (PI), Kinikar, Aarti Avinash, Raichur, Priyanka, Nijampurkar, Aparna, Khan, Sameer, Hissar, Syed, Joseph, Bency, Bhavani, Perumal Kannabiran, Prathiksha, G, Baskaran, Dhanaraj, Gomathi, NS, Mythily, V, Kumar, Hemanth, Chelvi, Silambu, Sekar, L, Hanna, Luke, Ramesh, K, Latha, Hema, Bharathi, S, Banu, Parveen, Xavier, Dino, Kumar, Manjith, Guru, K, Kumar, Sasi, Kesavan, A, Gunasundari, A, Mangalambal, G, Nagarajan, Valarmathi, Shankar, Shakeela, Selvi, R, Vaishnavi, S, Yadav, Krishna, Supriya, R, Giranab, Hema, Seetha, A, Mary, Stella, Gopika, S, Rohini, S, Revathy, M, Balaji, Sarath, Elilarasi, S, Ganesh, J, Aravind, MA, Mulambo, Sylvia, Mwanyungwi, Hope, Tapse, Dharati, Sane, Manasi, Abdullah, Amina, Nakalanzi, Sarah, Williams, Cynthia Mukisa, McIlleron, Helen, Aarnoutse, Rob, Revill, Paul, Love-Koh, James, Walker, Simon, Mugyenyi, Peter, Darbyshire, Janet, Clayden, Polly, Donald, Peter, Singh, Varinder, Grzemska*, Malgosia, Swaminathan, Soumya, Verkuijl, *Replaced by Sabine, Peto, Tim, Mwinga, Alwyn, Fielding, Katherine, Graham, Stephen M., Welch, Steven B., Seddon, James A., Whittaker, Elizabeth, Anderson, Suzanne, and Grandjean, Louis

Published
2023
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13. Factors Associated With Unfavorable Treatment Outcomes Among Persons With Pulmonary Tuberculosis: A Multicentric Prospective Cohort Study From India.

Author

Babu, Senbagavalli Prakash, Ezhumalai, Komala, Raghupathy, Kalaivani, Karoly, Meagan, Chinnakali, Palanivel, Gupte, Nikhil, Paradkar, Mandar, Devarajan, Arutselvi, Dhanasekaran, Mythili, Thiruvengadam, Kannan, Dauphinais, Madolyn Rose, Gupte, Akshay N, Shivakumar, Shrivijay Balayogendra, Thangakunam, Balamugesh, Christopher, Devasahayam Jesudas, Viswanathan, Vijay, Mave, Vidya, Gaikwad, Sanjay, Kinikar, Aarti, and Kornfeld, Hardy

Subjects
DRUG therapy for tuberculosis, MORTALITY risk factors, PATIENT compliance, RISK assessment, POISSON distribution, RESEARCH funding, MICROBIAL sensitivity tests, MULTIPLE regression analysis, TREATMENT effectiveness, DESCRIPTIVE statistics, AGE distribution, ANTITUBERCULAR agents, LONGITUDINAL method, SURVEYS, RESEARCH, TREATMENT failure, DISEASE relapse, CONFIDENCE intervals, REGRESSION analysis, EMPLOYMENT, EVALUATION, DISEASE risk factors
Abstract

In this prospective cohort of 2006 individuals with drug-susceptible tuberculosis in India, 18% had unfavorable treatment outcomes (4.7% treatment failure, 2.5% recurrent infection, 4.1% death, 6.8% loss to follow-up) over a median 12-month follow-up period. Age, male sex, low education, nutritional status, and alcohol use were predictors of unfavorable outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Long‐term risk of mortality and loss to follow‐up in children and adolescents on antiretroviral therapy in Asia.

Author

Nimkar, Smita, Kinikar, Aarti, Mave, Vidya, Khol, Vohith, Du, Quy Tuan, Nguyen, Lam, Ounchanum, Pradthana, Nguyen, Dinh Qui, Puthanakit, Thanyawee, Kosalaraks, Pope, Chokephaibulkit, Kulkanya, Sudjaritruk, Tavitiya, Muktiarti, Dina, Kumarasamy, Nagalingeswaran, Yusoff, Nik Khairulddin Nik, Mohamed, Thahira, Wati, Dewi, Alam, Anggraini, Fong, Siew, and Nallusamy, Revathy

Subjects
*VIRAL load, *ANTIRETROVIRAL agents, *CD4 lymphocyte count, *CHILD death, *DEATH rate
Abstract

Objective Methods Results Conclusion We described mortality and loss to follow‐up (LTFU) in children and adolescents who were under care for more than 5 years following initiation of antiretroviral therapy (ART).Patients were followed from 5 years after ART until the earlier of their 25th birthday, last visit, death, or LTFU. We used Cox regression to assess predictors of mortality and competing risk regression to assess factors associated with LTFU.In total, 4488 children and adolescents initiating ART between 1997 and 2016 were included in the analysis, with a median follow‐up time of 5.2 years. Of these, 107 (2.2%) died and 271 (6.0%) were LTFU. Mortality rate was 4.35 and LTFU rate 11.01 per 1000 person‐years. Increased mortality was associated with AIDS diagnosis (adjusted hazard ratio [aHR] 1.71; 95% confidence interval [CI] 1.24–2.37), current CD4 count <350 cells/mm3 compared with ≥500 (highest aHR 13.85; 95% CI 6.91–27.76 for CD4 <200), viral load ≥10 000 copies/mL compared with <400 (aHR 3.28; 95% CI 1.90–5.63), and exposure to more than one ART regimen (aHR 1.51; 95% CI 1.14–2.00). Factors associated with LTFU were male sex (adjusted subdistribution hazard ratio [asHR] 1.29; 95% CI 1.04–1.59), current viral load >1000 copies/mL compared with <400 (highest asHR 2.36; 95% CI 1.19–4.70 for viral load 1000–9999), and ART start after year 2005 compared with ≤2005 (highest asHR 5.96; 95% CI 1.98–17.91 for 2010–2016).For children and adolescents surviving 5 years on ART, both current CD4 and viral load remained strong indicators that help to keep track of their treatment outcomes. More effort should be made to monitor patients who switch treatments. [ABSTRACT FROM AUTHOR]

Published
2024
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17. The source of Drug-Resistant Bloodstream Infection in the Neonatal Intensive Care Unit, an Ongoing Conversation

Author

Robinson, Matthew L, primary, Johnson, Julia, additional, Naik, Shilpa, additional, Kinikar, Aarti, additional, Dohe, Vaishali, additional, Kagal, Anju, additional, Randive, Bharat, additional, Kadam, Abhay, additional, Karyakarte, Rajesh, additional, Mave, Vidya, additional, Gupta, Amita, additional, Milstone, Aaron M, additional, and Manabe, Yukari C, additional

Published
2024
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18. Isoniazid concentrations in hair and plasma area-under-the-curve exposure among children with tuberculosis

Author

Mave, Vidya, Kinikar, Aarti, Kagal, Anju, Nimkar, Smita, Koli, Hari, Khwaja, Sultanat, Bharadwaj, Renu, Gerona, Roy, Wen, Anita, Ramachandran, Geetha, Kumar, Hemanth, Bacchetti, Peter, Dooley, Kelly E, Gupte, Nikhil, Gupta, Amita, and Gandhi, Monica

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Tuberculosis, Orphan Drug, Rare Diseases, Patient Safety, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Antitubercular Agents, Area Under Curve, Child, Preschool, Humans, Isoniazid, Prospective Studies, General Science & Technology
Abstract

We measured hair and plasma concentrations of isoniazid among sixteen children with tuberculosis who underwent personal or video-assisted directly observed therapy and thus had 100% adherence. This study therefore defined typical isoniazid exposure parameters after two months of treatment among fully-adherent patients in both hair and plasma (plasma area under the concentration-time curve, AUC, estimated using pharmacokinetic data collected 0, 2, 4, and 6 hours after drug administration). We found that INH levels in hair among highly-adherent individuals did not correlate well with plasma AUC or trough concentrations, suggesting that each measure may provide incremental and complementary information regarding drug exposure in the context of TB treatment.

Published
2017

19. Severe Recurrent Bacterial Pneumonia Among Children Living With HIV

Author

Boettiger, David C., An, Vu Thien, Lumbiganon, Pagakrong, Wittawatmongkol, Orasri, Huu Truong, Khanh, Chau Do, Viet, Van Nguyen, Lam, Sun Ly, Penh, Kinikar, Aarti, Ounchanum, Pradthana, Puthanakit, Thanyawee, Kurniati, Nia, Kumarasamy, Nagalingeswaran, Kumara Wati, Dewi, Chokephaibulkit, Kulkanya, Jamal Mohamed, Thahira A., Sudjaritruk, Tavitiya, Nik Yusoff, Nik Khairulddin, Siew Fong, Moy, Nallusamy, Revathy A., and Kariminia, Azar

Published
2022
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20. Service delivery challenges in HIV care during the first year of the COVID‐19 pandemic: results from a site assessment survey across the global IeDEA consortium

Author

Brazier, Ellen, Ajeh, Rogers, Maruri, Fernanda, Musick, Beverly, Freeman, Aimee, Wester, C. William, Lee, Man?Po, Shamu, Tinei, Ramírez, Brenda Crabtree, D' Almeida, Marcelline, Wools?Kaloustian, Kara, Kumarasamy, N., Althoff, Keri N., Twizere, Christella, Grinsztejn, Beatriz, Tanser, Frank, Messou, Eugène, Byakwaga, Helen, Duda, Stephany N., Nash, Denis, Chansilpa, Chidchon, Dougherty, Trevor, Karminia, Azar, Law, Matthew, Ross, Jeremy, Sohn, Annette, Aguirre, Ivette, Baker, David, Bloch, Mark, Cabot, Safaa, Carr, Andrew, Couldwell, Deborah, Edwards, Sian, Eu, Beng, Farlow, Heather, Finlayson, Robert, Gunathilake, Manoji, Hazlewood, Cherie, Hoy, Jennifer, Langton?Lockton, Julian, Le, Jacqueline, Leprince, Elizabeth, Minc, Ariane, Moore, Richard, O'Sullivan, Maree, Roth, Norm, Rowling, Dianne, Russell, Darren, Ryder, Nathan, Saunders, Craig, Silvers, Julie, Smith, David J., Sowden, David, Sweeney, Grant, Tan, Lynn, Teague, Ricard, Templeton, David, Thng, Caroline, Woolley, Ian, Khol, Vohith, Ly, Penh Sun, Li, Tsz Hei, Po, Lee Man, Kinikar, Aarti, Kumarasamy, Nagalingeswaran, Mundhe, Sanjay, Pujari, Sanjay, Sangle, Shashikala, Nimkar, Smita, Jassin, Madelein, Kurniati, Nia, Merati, Tuti Parwati, Muktiarti, Dina, Amalia, Rizqi, Sukmawati, Ni Made Dewi Dian, Wati, Ketut Dewi Kumara, Yunihastuti, Evy, Tanuma, Junko, Choi, Jun Yong, Azwa, Raja Iskandar Shah Raja, Cheng, Chan Kwai, Gani, Yasmin Mohamed, Mohamed, Thahira Jamal, Moy, Fong Siew, Nallusamy, Revathy, Nor, Mohamad Zulfahami Mohd, Rudi, Nuraini, Shyan, Wong Peng, Yusoff, Nik Khairulddin Nik, Ditangco, Rossana, Chan, Yu?Jiun, Wu, Pei?Chieh, Wu, Ping?Feng, Avihingsanon, Anchalee, Chaiwarith, Romanee, Chokephaibulkit, Kulkanya, Khusuwan, Suwimon, Kiertiburanakul, Sasisopin, Kosalaraksa, Pope, Lumbiganon, Pagakrong, Ounchanam, Pradtana, Puthanakit, Thanyawee, Rungmaitree, Supattra, Solai, Nuttarika, Sudjaritruk, Tavitiya, An, Vu Thien, Cuong, Do Duy, Do, Chau Viet, Huy, Bui Vu, Quy, Tuan, Van Nguyen, Kinh, Nguyen, Luan, Nguyen, Van Lam, Nguyen, Yen Thi, Nong, Vuong Minh, Truong, Huu Khanh, Tuyen, Ngo Thi Thu, Mcgowan, Catherine C., Duda, Stephany, Cahn, Florencia, Cahn, Pedro, Cesar, Carina, Fink, Valeria, Sued, Omar, Coelho, Lara, Machado, Daisy Maria, Pinto, Jorge, Wolff, Marcelo, Rouzier, Vanessa, Padgett, Denis, Gotuzzo, Eduardo, Biziragusenyuka, Jérémie, Gateretse, Patrick, Nimbona, Pelagie, Niyonkuru, Olive, Twizere, Christelle, Anicetus, Surreng, Djenabou, Amadou, Enow, Priscilla, Mbu, Eyongetah, Manga, Martin, Ndobe, Mercy, Nasah, Judith, Ekossono, Elle Nathalie Syntyche, Bouseko, Mireille Teno, Kitetele, Faustin, Lelo, Patricia, Diafouka, Merlin Isidore Justin, Mafoua, Adolphe, Nsonde, Dominique Mahambou, Bihira, Uitonze Aime Maurice, Dusabe, Marie Chantal, Feza, Rosine, Habanabashaka, Jean Claude, Habumuremyi, Viateur, Igizeneza, Ernestine, Kamigisha, Anne Marie, Kubwimana, Gallican, Maniriho, Gilbert, Mbaraga, Gilbert, Muhoza, Benjamin, Mukakarangwa, Jeanne, Mukamana, Joyce, Mukanyirigira, Patricie, Mukeshimana, Yvone Claude, Munyaneza, Athanase, Murenzi, Gad, Musaninyange, Jacqueline, Nyiraneza, Jules Ndumuhire, Ntarambirwa, Fidele, Nyiraneza, Marie Louise, Tuyishime, Josette, Tuyishimire, Yvonne, Ubandutira, Alexis, Umugiraneza, Florance, Umugwaneza, Rosine, Uwamahoro, Olive, Uwamahoro, Pauline, Uwambaje, Marie Victoire, Uwimpuhwe, Clarisse, Uwiragiye, Siphora, Kuhn, Yee Yee, Adera, Felix, Adhiambo, Beatricec, Aggrey, Khaemba, Akadikor, Daniel, Ambulla, Felix, Apiyo, Dorah, Ariya, Patrick, Atemba, Naftal, Ayodi, Fridah, Benard, Chirchir, Bett, Maureen, Birgen, Serafine, Bwalei, Rael, Chebon, Nancy, Chebor, Valentine Jirry, Chebuiywo, Philip, Chemutai, Jacline, Chepkorir, Emily, Chepseba, Carolyne, Chirchir, John, Diero, Lameck, Dukwa, Benard, Elphas, Alice, Etyang, Tom, Idiama, Agnes, Jebichuko, Ann, Jepchumba, Delvine, Juma, Churchill, Juma, Maureen, Juma, Sheila, Kadima, Julie, Karani, Rose, Keitany, Christopher, Keter, Pricilla, Kiavoga, Lucy, Kibet, Harrison, Kimutai, Ruth, Kiplagat, Mutai, Kiprono, Wilfred, Kipruto, Nicholas Kogei, Kirimi, Asenath, Koech, Zeddy, Kosgei, Carolyne, Kutto, Karen, Kweyu, Mildred, Liech, Ephraim Kenneth, Limo, Milka, Maina, Rose, Marumbu, Priscah, Masese, Agnes, Mochotto, Patricia, Molly, Omudeck, Momanyi, Tom, Murutu, John W., Mwanda, Praxidis, Ndakalu, Lillian, Nderitu, Rose N., Obatsa, Sarah, Obiga, Fredrick, Oboya, Moses, Odhiambo, Joseph, Olaya, George, Omanyala, Oscar, Oray, Christine, Otieno, Molly, Otwane, Modesta Toto, Ouma, Paul, Owuor, Charles, Pepela, Doris Tutu, Pessah, Collins, Rotich, Evans, Rotich, Edwin K., Rutto, Titus C., Shikuku, Monica, Sibweche, Rose Naliaka, Simiyu, Robert Wanyonyi, Siria, Hellen, Some, Michael, Songok, Winnie Cherotich, Tanui, Immaculate, Wafula, Grace, Wambura, Rebecca, Wanjala, Ellah, Wanyama, Carolyne, Wanyonyi, Hellen, Woyakapel, Emmanuel, Zelbabel, Wandera, Gwimo, Dikengela, Kinyota, Ester, Lwali, Jerome, Lyamuya, Rita, Machemba, Richard, Mathias, Julia, Mkombachepa, Lilian, Mokiwa, Athuman, Mushi, Ombeni, Ndunguru, Charles, Ngonyani, Kapella, Nyaga, Charles, Ruta, Happiness, Urassa, Mark, Akanyihayo, James, Arinaitwe, Arnold, Batuuka, Jesca, Birungi, Walusimbi, Bugembe, John Nyanzi, Ddungu, Ahmed, Francis, Kato, Imran, Bangira, Kafuuma, George William, Kalulue, John Bosco, Kanaabi, Grace, Kanyesigye, Michale, Karuhanga, Godfery, Kasozi, Charles, Kasule, Godfrey, Katusime, Assumpta, Kibalama, Donozio, Kimera, Simon Peter, Kulusumu, Namatovu, Lule, Yusuf, Lwanga, Isaac, Mluindwa, Margaret, Moses, Jemba, Mubarak, Sseremba, Muggaga, Daniel, Mukalazi, Evelyn, Muleebwa, Joseph, Mulema, Derick, Musisi, Ivan, Muwawu, John, Muyindike, Winnie, Mwaka, Dick, Naava, Milly, Nabiyki, Immaculate, Nabusulwa, Agnes, Nakabugo, Dorah, Nakamya, Esther, Nakanwagi, Daisy, Nakato, Oliver, Nakayi, Lydian, Nakigozi, Patience, Nakku, Juliet, Nakuya, Juliet, Nakyomu, Justine, Namayanja, Joan, Namirembe, Sarah, Namugumya, Juliet, Namukasa, Ezereth, Namulindwa, Viola, Nankya, Irene, Nannyondo, Grace Mugagga, Nansamba, Harriet, Nansera, Denis, Nanyanzi, Brenda, Nanyonjo, Esther Celina, Nayiga, Irene, Opira, Isaac, Owarwo, Noela C., Resty, Sserunkuma, Semuwemba, Haruna, Senoga, Julius, Sseguya, Gerald, Ssekyewa, John Paul, Ssemakadde, Matthew, Tebajjwa, Jonah, Tugumisirize, Doreen, Tushemerirwe, Robinah, Waliyi, Kawuki, Althoff, Keri, Bishop, Jennifer, Gill, M J., Loutfy, Mona, Smith, Graham, Bamford, Laura, Black, Anthony, Brice, Asia, Brown, Sheldon, Colasanti, Jonathan, Duarte, Piper, Firnhaber, Cynthia, Goetz, Matthew, Grasso, Chris, Gripshover, Barbara, Horberg, Michael, Kelly, Rita, Levine, Ken, Luu, Mitchell, Marconi, Vincent, Maroney, Karen, Mayer, Kenneth, Mayor, Angel, Mcgowan, Catherine, Multani, Ami, Napravnik, Sonia, Nijhawan, Ank, Novak, Richard, Palella, Frank, Rodriguez, Maria C., Scott, Mia, Tedaldi, Ellen, Willig, James, Cornell, Morna, Davies, Mary?Ann, Egger, Matthias, Haas, Andreas, Bereng, Monkoe, Kalake, Maleshoane, Lenela, Keketso, Seretse, Relebohile, Chintenga, Matthews, Chiwoko, Jane, Gumulira, Joe, Huwa, Jacqueline, Maluwa, Rafique, Matanje, Beatrice, Mbewe, Ronald, Mfungwe, Sunshine, Mphande, Zakaliah, Tweya, Hannock, Rafael, Idiovino, Apolles, Patti, Beneke, Eunice, Dlamini, Siphephelo, Edson, Claire, Eley, Brian, Euvrard, Jonathan, Fatti, Geoffrey, Goeieman, Bridgette, Grimwood, Ashraf, Huang, David, Hugo, Susan, Ismail, Zahiera, Jennings, Lauren, Mathenjwa, Thulile, Monteith, Lizette, Mshweshwe, Zamuxolo, Ntuli, Mfundi, Ndlovu, En, Ndlozi, Hloniphile, Noyakaza, Sylvia, Prozesky, Hans, Rabie, Helena, Sipambo, Nosisa, Technau, Karl?Günter, Tembe, Thokozani, Xaba, Nontando, Njobvu, Thandiwe, Munthaly, Mary, Mwetwa, Elly, Kabeba, Gillian, Mwendafilumba, Derrick, Maanguka, Ethel, Manyika, Nelly, Mwansa, Chalwe, Banda, Future, Mwenda, Dickson, Bwalya, Abel, Shapi, Leah, Syame, Kasapo, Sashi, Rita, Mulenga, Chisha, Nanyangwe, Ruth, Chimbetete, Cleophas, Chinofunga, A., Mhike, J., Mubvigwi, E., Nyika, F., Quarter, Kumbirai Pise, Arikawa, Shino Chassagne, Becquet, Renaud, Bernard, Charlotte, Dabis, François, Desmonde, Sophie, Dahourou, Désiré, Ekouevi, Didier Koumavi, Jaquet, Antoine, Jesson, Julie, Leroy, Valeriane, Malateste, Karen, Rabourdin, Elodie, Tiendrebeogo, Thierry, Assogba, Michée, Zannou, Djimon Marcel, Hounhoui, Ghislaine, Bere, Denise, Poda, Armel, Pooda, Gbolo, Traore, Richard, Abauble, Yao, Abby, Ouattara, Acquah, Patrick, Andoble, Valérie, Aude, Yobo N'Dzama, Azani, Jean?Claude, Berete, Oka, Beugre, Jacques Daple, Bohoussou, Caroline Yao, Brou, Simon Boni Emmanuel, Chenal, Henri, Cissé, Abdoulaye, Coulibaly, Nambate, Dainguy, Marie Evelyne, Daligou, Marcelle, D' Aquin, Toni Thomas, Dasse, Claude Desire, Folquet, Madeleine Amorissani, Gnepa, Guy, Gobe, Olivier, Guira, Salif, Hawerlander, Denise, Horo, Apollinaire, Kanga, Guillaume, Messou, Zobo Konan Eugène, Minga, Kla Albert, Moh, Raoul, N'Gbeche, Mariesylvie, Ogbo, Patricia, Oulai, Mathieu, Stéphanie, Se, Eboua, Tanoh, Valère, Itchy Max, Afrane, Adwoa Kumiwa Asare, Akrofi, Esther, Andoh, John Christian, Renner, Lorna, Bagayoko, Awa, Bagayoko, Kadidiatou, Bah, Abdou Salam, Berthe, Alima, Coulibaly, Boureïma, Coulibaly, Fatimata, Coulibaly, Yacouba Aba, Diakité, Aïssata, Bocoum, Fatoumata, Boré, Fatoumata, Dicko, Fatoumata, Koné, Odile, Sylla, Mariam, Tangara, Assitan, Traoré, Mamadou, Seydi, Moussa, Amegatse, Edmond, Djossou, Julienne, Takassi, Elom, and Palanga, Sénam

Subjects
HIV (Viruses) -- Care and treatment -- Patient outcomes, Public health administration -- Evaluation, Health
Abstract

: Introduction: Interruptions in treatment pose risks for people with HIV (PWH) and threaten progress in ending the HIV epidemic; however, the COVID‐19 pandemic's impact on HIV service delivery across diverse settings is not broadly documented. Methods: From September 2020 to March 2021, the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium surveyed 238 HIV care sites across seven geographic regions to document constraints in HIV service delivery during the first year of the pandemic and strategies for ensuring care continuity for PWH. Descriptive statistics were stratified by national HIV prevalence ( Results: Questions about pandemic‐related consequences for HIV care were completed by 225 (95%) sites in 42 countries with low (n = 82), medium (n = 86) and high (n = 57) HIV prevalence, including low‐ (n = 57), lower‐middle (n = 79), upper‐middle (n = 39) and high‐ (n = 50) income countries. Most sites reported being subject to pandemic‐related restrictions on travel, service provision or other operations (75%), and experiencing negative impacts (76%) on clinic operations, including decreased hours/days, reduced provider availability, clinic reconfiguration for COVID‐19 services, record‐keeping interruptions and suspension of partner support. Almost all sites in low‐prevalence and high‐income countries reported increased use of telemedicine (85% and 100%, respectively), compared with less than half of sites in high‐prevalence and lower‐income settings. Few sites in high‐prevalence settings (2%) reported suspending antiretroviral therapy (ART) clinic services, and many reported adopting mitigation strategies to support adherence, including multi‐month dispensing of ART (95%) and designating community ART pick‐up points (44%). While few sites (5%) reported stockouts of first‐line ART regimens, 10–11% reported stockouts of second‐ and third‐line regimens, respectively, primarily in high‐prevalence and lower‐income settings. Interruptions in HIV viral load (VL) testing included suspension of testing (22%), longer turnaround times (41%) and supply/reagent stockouts (22%), but did not differ across settings. Conclusions: While many sites in high HIV prevalence settings and lower‐income countries reported introducing or expanding measures to support treatment adherence and continuity of care, the COVID‐19 pandemic resulted in disruptions to VL testing and ART supply chains that may negatively affect the quality of HIV care in these settings., INTRODUCTION The COVID‐19 pandemic has had major direct and indirect impacts on population health globally, through disruptions in the accessibility and quality of basic health services [1], in supply chains [...]

Published
2022
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22. Pharmaceutical cost dynamics for the treatment of rifampicin-resistant tuberculosis in children and adolescents in South Africa, India, and the Philippines.

Author

Wilkinson, Thomas, Garcia-Prats, Anthony J., Sachs, Tina, Paradkar, Mandar, Suryavanshi, Nishi, Kinikar, Aarti, Frias, Melchor V., Sinanovic, Edina, Hesseling, Anneke C., Seddon, James. A., and Palmer, Megan

Subjects
RIFAMPIN, DRUG prices, ECONOMIC research, TUBERCULOSIS, COST analysis, TEENAGERS
Abstract

Rifampicin-resistant (RR) tuberculosis (TB) in children is a major global health concern but is often neglected in economics research. Accurate cost estimations across the spectrum of paediatric RR-TB treatment regimens are critical inputs for prioritisation and budgeting decisions, and an existing knowledge gap at local and international levels. This normative cost analysis was nested in a Phase I/II pharmacokinetics, safety, tolerability, and acceptability trial of TB medications in children in South Africa, the Philippines and India. It assessed the pharmaceutical costs of 36 childhood RR-TB regimens using combinations from 16 different medicines in 34 oral formulations (adult and child-friendly) in 11 weight bands in children <15 years of age. The analysis used local and Global Drug Facility pricing, and local and international guideline recommendations, including adaptions of BPaL and BPaLM regimens in adults. Costs varied significantly between regimen length, age/weight banding, severity of disease, presence of fluroquinolone resistance, and different country guideline recommendations. WHO recommended regimen costs ranged 12-fold: from US$232 per course (short regimen in non-severe disease) to US$2,761 (long regimen in severe, fluroquinolone-resistant disease). Regimen treating fluoroquinolone-resistant infection cost US$1,090 more than comparable WHO-recommended regimen. Providing child-friendly medicine formulations in <5-year-olds across all WHO-recommended regimens is expected to cost an additional $380 (range $212-$563) per child but is expected to have wider benefits including palatability, acceptability, adherence, tolerability, and dose accuracy. There were substantial differences in regimen affordability between countries when adjusted for purchasing power and domestic spending on health. Appropriate, effective, and affordable treatment options are an important component of the fight against childhood RR-TB. A comprehensive understanding of the cost and affordability dynamics of treatment options will enable national TB programs and global collaborations to make the best use of limited healthcare resources for the care of children with RR-TB. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial.

Author

Chabala, Chishala, Wobudeya, Eric, Zalm, Marieke M van der, Kapasa, Monica, Raichur, Priyanka, Mboizi, Robert, Palmer, Megan, Kinikar, Aarti, Hissar, Syed, Mulenga, Veronica, Mave, Vidya, Musoke, Philippa, Hesseling, Anneke C, McIlleron, Helen, Gibb, Diana, Crook, Angela, Turkova, Anna, and Team, the SHINE Trial

Subjects
DRUG therapy for tuberculosis, TUBERCULOSIS mortality, HIV infection complications, ANEMIA, SECONDARY analysis, LEANNESS, RESEARCH funding, VIRAL load, MALNUTRITION, HIV-positive persons, HOSPITAL care, CD4 lymphocyte count, HEMOGLOBINS, HIV infections, TREATMENT effectiveness, DESCRIPTIVE statistics, ANTITUBERCULAR agents, ODDS ratio, ANTI-HIV agents, COMPARATIVE studies, DISEASE relapse, ADVERSE health care events, CONFIDENCE intervals, CHILDREN
Abstract

Background Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial. Methods SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH. Results Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P =.07) but more underweight (weight-for-age z score, −2.3; (3.3, −0.8 versus −1.0; −1.8, −0.2; P <.01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P <.01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241–1134), and CD4% was 16% (10–26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3–4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42). Conclusions We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration.  ISRCTN63579542. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Knowledge, attitude, and practices among police force toward covid-19 pandemic during Lockdown in Pune, India - An Online cross-sectional survey

Author

D Sonkawade Naresh, A Kinikar Aarti, Rajesh Kulkarni, Chhaya Valvi, Uday C Rajput, Rahul Dawre, Sameer Pawar, Tushar Jadhav, Ajay Chandanwale, Muralidhar Tambe, K Venkatesham, and Nishi Suryavanshi

Subjects
covid-19, knowledge, lockdown, police, practices, Medicine
Abstract

Background: COVID-19 has affected millions of people and more than thirty thousand deaths. Social distancing and lockdown are important measures for prevention. Police personnel are losing their lives due to COVID-19 while doing their duty in this lockdown time. Aim: The study aims to assess knowledge, attitude, and practices (KAP) of police force toward COVID-19. To assess correlation of knowledge with their practices and attitude. Materials and Methods: A cross-sectional, self-administered, anonymous survey questionnaire was administered to 8706 police personnel and data collected over a time period from April 11 to 16, 2020. We used t-test and multivariable binary logistic regression analysis to identify the association between KAP and demographic variables. Results: In all 8706 police personnel participated in the study. The median age of participants was 35 years (interquartile range: 19–59), 6787 (77.9%) were male, 6675 (76.6%) were of constable grade. Seven thousand three hundred thirty-two (83.7%) of participants recorded accurate (high) knowledge, and 6790 (78%) reported following preventive practices. Female participants were more likely to follow preventive measures despite low knowledge as compared to their male counterparts (P < 0.0001). Female gender, age more than 35 years, and lower rank were associated with low knowledge and fear of contracting the disease. Multivariable binary logistic regression analysis showed that low knowledge is significantly associated with fear of getting disease odds ratio 1.29; 95% confidence interval (1.15–1.46). Conclusion: In a cohort of police personnel, overall knowledge about COVID-19 is high. Female participants are found to be practicing appropriate preventive measures and they have faced stigmatizing behavior from society. The study provides important information on the need for developing health awareness programs to improve COVID-19 KAP.

Published
2021
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27. Intensified Short Symptom Screening Program for Dengue Infection during Pregnancy, India

Author

Naik, Shilpa, Robinson, Matthew L., Alexander, Mallika, Chandanwale, Ajay, Sambarey, Pradip, Kinikar, Aarti, Bharadwaj, Renu, Sapkal, Gajanan N., Chebrolu, Puja, Deshpande, Prasad, Kulkarni, Vandana, Nimkar, Smita, Mave, Vidya, Gupta, Amita, and Mathad, Jyoti

Subjects
Conjunctivitis -- Diagnosis, Dengue fever -- Diagnosis, Pregnancy, Pregnant women, Time, Polymerase chain reaction, Malaria, Intelligence gathering, Rash, Women, Diseases, Health
Abstract

Every year, an estimated 96 million persons worldwide are given a clinical diagnosis of severe dengue infection (1). In 2017, a total of 188,401 cases of dengue were diagnosed in [...]

Published
2020
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33. High Burden of Antimicrobial Resistance and Mortality Among Adults and Children With Community-Onset Bacterial Infections in India

Author

Mave, Vidya, Chandanwale, Ajay, Kagal, Anju, Khadse, Sandhya, Kadam, Dileep, Bharadwaj, Renu, Dohe, Vaishali, Robinson, Matthew L., Kinikar, Aarti, Joshi, Samir, Raichur, Priyanka, McIntire, Katie, Kanade, Savita, Sachs, Jonathan, Valvi, Chhaya, Balasubramanian, Usha, Kulkarni, Vandana, Milstone, Aaron M., Marbaniang, Ivan, Zenilman, Jonathan, and Gupta, Amita

Published
2017

34. Maternal Colonization Versus Nosocomial Transmission as the Source of Drug-Resistant Bloodstream Infection in an Indian Neonatal Intensive Care Unit: A Prospective Cohort Study

Author

Robinson, Matthew L, primary, Johnson, Julia, additional, Naik, Shilpa, additional, Patil, Sunil, additional, Kulkarni, Rajesh, additional, Kinikar, Aarti, additional, Dohe, Vaishali, additional, Mudshingkar, Swati, additional, Kagal, Anju, additional, Smith, Rachel M, additional, Westercamp, Matthew, additional, Randive, Bharat, additional, Kadam, Abhay, additional, Babiker, Ahmed, additional, Kulkarni, Vandana, additional, Karyakarte, Rajesh, additional, Mave, Vidya, additional, Gupta, Amita, additional, Milstone, Aaron M, additional, and Manabe, Yukari C, additional

Published
2023
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36. Integration of HIV care into maternal and child health services in the global IeDEA consortium

Author

Humphrey, John, primary, Nagel, Elizabeth, additional, Carlucci, James G., additional, Edmonds, Andrew, additional, Kinikar, Aarti, additional, Anderson, Kim, additional, Leroy, Valériane, additional, Machado, Daisy, additional, Yin, Dwight E., additional, Tulio Luque, Marco, additional, Amorissani-Folquet, Madeleine, additional, Mbewe, Safari, additional, Suwanlerk, Tulathip, additional, Munyaneza, Athanase, additional, Patel, Rena C., additional, Musick, Beverly, additional, Abuogi, Lisa, additional, and Wools-Kaloustian, Kara, additional

Published
2023
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40. Consensus Competencies for Postgraduate Fellowship Training in Global Neurology

Author

Schiess, Nicoline, primary, Kulo, Violet, additional, Anand, Pria, additional, Bearden, David R., additional, Berkowitz, Aaron L., additional, Birbeck, Gretchen L., additional, Cervantes-Arslanian, Anna, additional, Chan, Phillip, additional, Chishimba, Lorraine Chishimba, additional, Chow, Felicia C., additional, Elicer, Isabel, additional, Fleury, Agnes, additional, Kinikar, Aarti, additional, Kvalsund, Michelle, additional, Mateen, Farrah J., additional, Mbonde, Amir A., additional, Meyer, Ana-Claire L., additional, O'Carroll, Cumara B., additional, Ogunniyi, Adesola, additional, Patel, Archana A., additional, Rubenstein, Michael, additional, Siddiqi, Omar K., additional, Spudich, Serena, additional, Tackett, Sean A., additional, Thakur, Kiran T., additional, Vora, Nirali, additional, Zunt, Joseph, additional, and Saylor, Deanna R., additional

Published
2023
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41. Global estimates and determinants of antituberculosis drug pharmacokinetics in children and adolescents : a systematic review and individual patient data meta-analysis

Author

Gafar, Fajri, Wasmann, Roeland E., McIlleron, Helen M., Aarnoutse, Rob E., Schaaf, H. Simon, Marais, Ben J., Agarwal, Dipti, Antwi, Sampson, Bang, Nguyen D., Bekker, Adrie, Bell, David J., Chabala, Chishala, Choo, Louise, Davies, Geraint R., Day, Jeremy N., Dayal, Rajeshwar, Denti, Paolo, Donald, Peter R., Engidawork, Ephrem, Garcia-Prats, Anthony J., Gibb, Diana, Graham, Stephen M., Hesseling, Anneke C., Heysell, Scott K., Idris, Misgana I., Kabra, Sushil K., Kinikar, Aarti, Kumar, Agibothu K. Hemanth, Kwara, Awewura, Lodha, Rakesh, Magis-Escurra, Cecile, Martinez, Nilza, Mathew, Binu S., Mave, Vidya, Mduma, Estomih, Mlotha-Mitole, Rachel, Mpagama, Stellah G., Mukherjee, Aparna, Nataprawira, Heda M., Peloquin, Charles A., Pouplin, Thomas, Ramachandran, Geetha, Ranjalkar, Jaya, Roy, Vandana, Ruslami, Rovina, Shah, Ira, Singh, Yatish, Sturkenboom, Marieke G. G., Svensson, Elin M., Swaminathan, Soumya, Thatte, Urmila, Thee, Stephanie, Thomas, Tania A., Tikiso, Tjokosela, Touw, Daan J., Turkova, Anna, Velpandian, Thirumurthy, Verhagen, Lilly M., Winckler, Jana L., Yang, Hongmei, Yunivita, Vycke, Taxis, Katja, Stevens, Jasper, Alffenaar, Jan-Willem C., Gafar, Fajri, Wasmann, Roeland E., McIlleron, Helen M., Aarnoutse, Rob E., Schaaf, H. Simon, Marais, Ben J., Agarwal, Dipti, Antwi, Sampson, Bang, Nguyen D., Bekker, Adrie, Bell, David J., Chabala, Chishala, Choo, Louise, Davies, Geraint R., Day, Jeremy N., Dayal, Rajeshwar, Denti, Paolo, Donald, Peter R., Engidawork, Ephrem, Garcia-Prats, Anthony J., Gibb, Diana, Graham, Stephen M., Hesseling, Anneke C., Heysell, Scott K., Idris, Misgana I., Kabra, Sushil K., Kinikar, Aarti, Kumar, Agibothu K. Hemanth, Kwara, Awewura, Lodha, Rakesh, Magis-Escurra, Cecile, Martinez, Nilza, Mathew, Binu S., Mave, Vidya, Mduma, Estomih, Mlotha-Mitole, Rachel, Mpagama, Stellah G., Mukherjee, Aparna, Nataprawira, Heda M., Peloquin, Charles A., Pouplin, Thomas, Ramachandran, Geetha, Ranjalkar, Jaya, Roy, Vandana, Ruslami, Rovina, Shah, Ira, Singh, Yatish, Sturkenboom, Marieke G. G., Svensson, Elin M., Swaminathan, Soumya, Thatte, Urmila, Thee, Stephanie, Thomas, Tania A., Tikiso, Tjokosela, Touw, Daan J., Turkova, Anna, Velpandian, Thirumurthy, Verhagen, Lilly M., Winckler, Jana L., Yang, Hongmei, Yunivita, Vycke, Taxis, Katja, Stevens, Jasper, and Alffenaar, Jan-Willem C.

Abstract

Background Suboptimal exposure to antituberculosis (anti-TB) drugs has been associated with unfavourable treatment outcomes. We aimed to investigate estimates and determinants of first-line anti-TB drug pharmacokinetics in children and adolescents at a global level. Methods We systematically searched MEDLINE, Embase and Web of Science (1990–2021) for pharmacokinetic studies of first-line anti-TB drugs in children and adolescents. Individual patient data were obtained from authors of eligible studies. Summary estimates of total/extrapolated area under the plasma concentration–time curve from 0 to 24 h post-dose (AUC0–24) and peak plasma concentration (Cmax) were assessed with random-effects models, normalised with current World Health Organization-recommended paediatric doses. Determinants of AUC0–24 and Cmax were assessed with linear mixed-effects models. Results Of 55 eligible studies, individual patient data were available for 39 (71%), including 1628 participants from 12 countries. Geometric means of steady-state AUC0–24 were summarised for isoniazid (18.7 (95% CI 15.5–22.6) h·mg·L−1), rifampicin (34.4 (95% CI 29.4–40.3) h·mg·L−1), pyrazinamide (375.0 (95% CI 339.9–413.7) h·mg·L−1) and ethambutol (8.0 (95% CI 6.4–10.0) h·mg·L−1). Our multivariate models indicated that younger age (especially <2 years) and HIV-positive status were associated with lower AUC0–24 for all first-line anti-TB drugs, while severe malnutrition was associated with lower AUC0–24 for isoniazid and pyrazinamide. N-acetyltransferase 2 rapid acetylators had lower isoniazid AUC0–24 and slow acetylators had higher isoniazid AUC0–24 than intermediate acetylators. Determinants of Cmax were generally similar to those for AUC0–24. Conclusions This study provides the most comprehensive estimates of plasma exposures to first-line anti-TB drugs in children and adolescents. Key determinants of drug exposures were identified. These may be relevant for population-specific dose adjustment or individualis

Published
2023
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43. THE DETERMINANTS OF SHORTER TIME TAKEN TO REACH FULL FEED AMONG EXTREMELY LOW BIRTH WEIGHT NEWBORNS ADMITTED TO LEVEL III NEONATAL INTENSIVE CARE UNIT OF GOVERNMENT HOSPITAL

Author

Manesh Uddhav Kale, Isha Deshmukh, Kinikar, Aarti, Valvi, Chhaya, and Dawre, Rahul

Subjects
ELBW NEC VS GA NICU
Abstract

Background:Although extremely low gestational age newborns (ELGANs) or extremely low birth weight (ELBW)newborns are born they have their third-trimester intrauterine life pertaining to development. During this time, one of theobjectives of the NICU staff is to feed the newborn with enough nourishment to reach a growth velocity (GV) comparable to intrauterine GV. Early parenteral & enteral nutritionto ELBW infants during the first twenty-four hrs of life leads to a quick recovery of weight loss, enhanced overall weight growth, and earlier accomplishment of complete enteral feeding. Early & substantial protein administration has also been linked to increased weight gain & brain growth. Aims/Objective:To identify determinants of shorter time taken to reach full feeds among ELBW admitted to level III NICU. Method:It was a retrospective hospital-based study conducted from April 2022 to September 2022 and included 55 ELBW newborns admitted to NICU satisfying the WHO definition of ELBW and categorizedinto group I(28 wks. till 31 wks.). Various determinants like ventilatory support, surfactant therapy, NEC, gestational age (GA), etc. are used for analysis. Results:55 ELBW analysed their mean gestational age (27±3.1) weeks, Range (25-31 weeks) Mean Birth weight (884±114 gram) Range (500- Conclusion:ELBW newborns who require minimal ventilatory support, no surfactant, less association with NEC, IVH, Sepsis, and average gestation age above 28 weeks attained early full feed regain birth weight also decreases hospital stay. Funding source:None. Ethics committee clearance submitted Conflict of interest:None. &nbsp

Published
2023
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47. The changing characteristics of a cohort of children and adolescents living with HIV at antiretroviral therapy initiation in Asia.

Author

Sornillo, Johanna Beulah, Ditangco, Rossana, Kinikar, Aarti, Wati, Dewi Kumara, Du, Quy Tuan, Nguyen, Dinh Qui, Khol, Vohith, Nguyen, Lam Van, Puthanakit, Thanyawee, Ounchanum, Pradthana, Kurniati, Nia, Chokephaibulkit, Kulkanya, Jamal Mohamed, Thahira A., Sudjaritruk, Tavitiya, Fong, Siew Moy, Kumarasamy, Nagalingeswaran, Kosalaraksa, Pope, Nallusamy, Revathy A., Nik Yusoff, Nik Khairulddin, and Sohn, Annette H.

Subjects
HIV-positive children, HIV-positive teenagers, HIV, ANTIRETROVIRAL agents, ORPHANS, TEENAGE girls, DIAGNOSIS of HIV infections, OPPORTUNISTIC infections
Abstract

Despite improvements in HIV testing and earlier antiretroviral therapy (ART) initiation in children living with HIV through the years, a considerable proportion start treatment with advanced disease. We studied characteristics of children and adolescents living with HIV and their level of immunodeficiency at ART initiation using data from a multi-country Asian cohort. We included children and adolescents who were ART-naïve and <18 years of age at ART initiation from 2011 to 2020 at 17 HIV clinics in six countries. Incidence rates of opportunistic infections (OIs) in the first two years of triple-drug ART (≥3 antiretrovirals) was also reported. Competing risk regression analysis was performed to identify factors associated with first occurrence of OI. In 2,027 children and adolescents (54% males), median age at ART initiation increased from 4.5 years in 2011–2013 to 6.7 in 2017–2020, median CD4 count doubled from 237 cells/μl to 466 cells/μl, and proportion of children who initiated ART as severely immunodeficient decreased from 70% to 45%. During follow-up, 275 (14%) children who received triple-drug ART as first treatment and had at least one clinic visit, developed at least one OI in the first two years of treatment (9.40 per 100 person-years). The incidence rate of any first OI declined from 12.52 to 7.58 per 100 person-years during 2011–2013 and 2017–2020. Lower hazard of OIs were found in those with age at first ART 2–14 years, current CD4 ≥200 cells/μl, and receiving ART between 2017 and 2020. The analysis demonstrated increasing number of children and adolescents starting ART with high CD4 count at ART start. The rate of first OI markedly decreased in children who started ART in more recent years. There remains a clear need for improvement in HIV control strategies in children, by promoting earlier diagnosis and timely treatment. [ABSTRACT FROM AUTHOR]

Published
2023
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48. “Mobilizing our leaders”: A multi-country qualitative study to increase the representation of women in global health leadership

Author

Riche, Claudia T., primary, Reif, Lindsey K., additional, Nguyen, Natalie T., additional, Alakiu, G. Rinu, additional, Seo, Grace, additional, Mathad, Jyoti S., additional, McNairy, Margaret L., additional, Cordeiro, Alexandra A., additional, Kinikar, Aarti, additional, Walsh, Kathleen F., additional, Deschamps, Marie Marcelle, additional, Nerette, Sandy, additional, Nimkar, Smita, additional, Kayange, Neema, additional, Jaka, Hyasinta, additional, Mwaisungu, Halima M., additional, Morona, Domenica, additional, Peter, Thandiwe Yvonne, additional, Suryavanshi, Nishi, additional, Fitzgerald, Daniel W., additional, Downs, Jennifer A., additional, and Hokororo, Adolfine, additional

Published
2023
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50. Impact of Undernutrition on Tuberculosis Treatment Outcomes in India: A Multicenter, Prospective, Cohort Analysis

Author

Sinha, Pranay, primary, Ponnuraja, Chinnaiyan, additional, Gupte, Nikhil, additional, Babu, Senbagavalli Prakash, additional, Cox, Samyra R, additional, Sarkar, Sonali, additional, Mave, Vidya, additional, Paradkar, Mandar, additional, Cintron, Chelsie, additional, Govindarajan, S, additional, Kinikar, Aarti, additional, Priya, Nadesan, additional, Gaikwad, Sanjay, additional, Thangakunam, Balamugesh, additional, Devarajan, Arutselvi, additional, Dhanasekaran, Mythili, additional, Tornheim, Jeffrey A, additional, Gupta, Amita, additional, Salgame, Padmini, additional, Christopher, Devashyam Jesudas, additional, Kornfeld, Hardy, additional, Viswanathan, Vijay, additional, Ellner, Jerrold J, additional, Horsburgh, C Robert, additional, Gupte, Akshay N, additional, Padmapriyadarsini, Chandrasekaran, additional, and Hochberg, Natasha S, additional

Published
2022
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