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1. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Author

Davey, Richard T, Fernández-Cruz, Eduardo, Markowitz, Norman, Pett, Sarah, Babiker, Abdel G, Wentworth, Deborah, Khurana, Surender, Engen, Nicole, Gordin, Fred, Jain, Mamta K, Kan, Virginia, Polizzotto, Mark N, Riska, Paul, Ruxrungtham, Kiat, Temesgen, Zelalem, Lundgren, Jens, Beigel, John H, Lane, H Clifford, Neaton, James D, Butts, Jessica, Denning, Eileen, DuChene, Alain, Krum, Eric, Harrison, Merrie, Meger, Sue, Peterson, Ross, Quan, Kien, Shaughnessy, Megan, Thompson, Greg, Vock, David, Metcalf, Julia, Dewar, Robin, Rehman, Tauseef, Natarajan, Ven, McConnell, Rose, Flowers, Emily, Smith, Kenny, Hoover, Marie, Coyle, Elizabeth M, Munroe, David, Aagaard, Bitten, Pearson, Mary, Cursley, Adam, Webb, Helen, Hudson, Fleur, Russell, Charlotte, Sy, Aminata, Purvis, Cara, Jackson, Brooke, Collaco-Moraes, Yolanda, Carey, Dianne, Robson, Rosemary, Sánchez, Adriana, Finley, Elizabeth, Conwell, Donna, Losso, Marcelo H, Gambardella, Luciana, Abela, Cecilia, Lopez, Paco, Alonso, Helena, Touloumi, Giota, Gioukari, Vicky, Anagnostou, Olga, Avihingsanon, Anchalee, Pussadee, Kanitta, Ubolyam, Sasiwimol, Omotosho, Bola, Solórzano, Clemencia, Petersen, Tianna, Vysyaraju, Kranthi, Rizza, Stacey A, Whitaker, Jennifer A, Nahra, Raquel, Baxter, John, Coburn, Patricia, Gardner, Edward M, Scott, James A, Faber, Leslie, Pastor, Erica, Makohon, Linda, MacArthur, Rodger A, Hillman, L Monique, Farrough, Marti J, Polenakovik, Hari M, Clark, Linda A, Colon, Roberto J, Kunisaki, Ken M, DeConcini, Miranda, Johnson, Susan A, Wolfe, Cameron R, Mkumba, Laura, Carbonneau, June Y, Morris, Alison, Fitzpatrick, Meghan E, Kessinger, Cathy J, Salata, Robert A, Arters, Karen A, Tasi, Catherine M, Panos, Ralph J, Lach, Laura A, Glesby, Marshall J, Ham, Kirsis A, Hughes, Valery G, Schooley, Robert T, Crouch, Daniel, Muttera, Leticia, Novak, Richard M, Bleasdale, Susan C, Zuckerman, Ariel E, Manosuthi, Weerawat, Thaonyen, Supeda, Chiewcharn, Thaniya, Suwanpimolkul, Gompol, Gatechumpol, Sivaporn, Bunpasang, Sirikunya, Angus, Brian J, Anderson, Monique, Morgan, Marcus, Minton, Jane, Gkamaletsou, Maria N, Hambleton, Joe, Price, David A, Llewelyn, Martin J, Sweetman, Jonathan, Carbone, Javier, Arribas, Jose R, Montejano, Rocio, Lobo Beristain, Jose L, Martinez, Iñaki Z, Barberan, Jose, Hernandez, Paola, Dwyer, Dominic E, Kok, Jen, Borges, Alvaro, Brandt, Christian T, Knudsen, Lene S, Sypsas, Nikolaos, Constantinou, Costas, Markogiannakis, Antonios, Zakynthinos, Spyros, Katsaounou, Paraskevi, Kalomenidis, Ioannis, Mykietiuk, Analia, Alzogaray, Maria F, Obed, Mora, Macias, Laura M, Ebensrtejin, Juan, Burgoa, Patricia, Nannini, Esteban, Lahitte, Matias, Perez-Patrigeon, Santiago, Martínez-Orozco, José Arturo, Ramírez-Hinojosa, Juan Pablo, and Davey, Richard T, Jr

Published
2019
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2. Sexually transmitted infections and HIV RNA levels in blood and anogenital compartments among Thai men who have sex with men before and after antiretroviral therapy: implication for Treatment as Prevention programme

Author

Phanuphak, Nittaya, Pattanachaiwit, Supanit, Pankam, Tippawan, Teeratakulpisarn, Nipat, Chamnan, Parinya, Pathipvanich, Panita, Thongpaen, Suchart, Nonenoy, Siriporn, Jantarapakde, Jureeporn, Pengnonyang, Supabhorn, Trachunthong, Deondara, Sungsing, Thanthip, Parasate, Kittiyaporn, Ayutthaya, Sriprai Seeneewong Na, Trairat, Ketmookda, Pussadee, Kanitta, Lertpiriyasuwat, Cheewanan, and Phanuphak, Praphan

Subjects
Sexually transmitted diseases -- Complications and side effects, HIV infections -- Risk factors -- Diagnosis -- Drug therapy -- Genetic aspects, MSM (Men who have sex with men) -- Health aspects, Antiretroviral agents -- Dosage and administration, Health
Abstract

Introduction: Sexually transmitted infections (STIs) are common among HIV-positive men who have sex with men (MSM). There have been concerns that undiagnosed and untreated STIs could undermine efforts to use antiretroviral therapy (ART) for prevention due to genital secretion infectiousness. We evaluated the correlation between STIs and HIV RNA in anogenital compartments among HIV-positive MSM before and after ART. Methods: MSM participants newly diagnosed with HIV were offered ART regardless of CD4 count during November 2012 to November 2015. Syphilis serology, oropharyngeal swab, rectal swab, urine collection for gonorrhoea and chlamydia nucleic acid amplification testing, and HIV RNA measurement in blood, semen and rectal samples were performed at baseline, 12 and 24 months thereafter. Results: Of 143 HIV-positive MSM, 16.1% had syphilis, 23.1% had gonorrhoea and 32.8% had chlamydia at baseline. Participants with STIs at baseline had higher median HIV RNA levels in blood plasma (p = 0.053), seminal plasma (p = 0.01) and rectal secretions (p = 0.002) than those without STIs. Multivariate models identified HIV RNA 100,000 to 500,000 (OR 6.74, 95% CI 2.24 to 20.28, p = 0.001) and >500,000 (OR 9.39, 95% CI 1.08 to 81.72, p = 0.04) copies/mL in blood, CD4 count 40 copies/mL) seminal plasma HIV RNA. Having chlamydia at any sites (OR 3.17, 95% CI 1.07 to 9.44, p = 0.04) was associated with detectable rectal HIV RNA. Incidences of syphilis, gonorrhoea and chlamydia were 13.4, 16.4 and 18.1 per 100 person-years respectively. Nine participants had detectable HIV RNA (five in blood, one in semen, two in rectal samples and one in both blood and rectal samples) at 12 and/or 24 months after ART. Conclusions: STIs were extremely common among HIV-positive MSM prior to and after ART. ART effectively reduced HIV RNA in all compartments. The correlation between STIs and anogenital HIV RNA, especially prior to ART and likely until complete HIV RNA suppression from ART is achieved, points to the importance of integrating asymptomatic STIs screening into Treatment as Prevention programme for MSM. Keywords: anogenital; HIV RNA; men who have sex with men; sexually transmitted infections; treatment as prevention, 1 | INTRODUCTION Sexually transmitted infections (STIs) have been associated with biological risk for HIV transmission and acquisition [1]. For men who have sex with men (MSM), these STIs can [...]

Published
2018
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3. Comparison of the Outcomes of Individuals With Medically Attended Influenza A and B Virus Infections Enrolled in 2 International Cohort Studies Over a 6-Year Period: 2009–2015

Author

Dwyer, Dominic E, Lynfield, Ruth, Losso, Marcelo H, Davey, Richard T, Cozzi-Lepri, Alessandro, Wentworth, Deborah, Uyeki, Timothy M, Gordin, Fred, Angus, Brian, Qvist, Tavs, Emery, Sean, Lundgren, Jens, Neaton, James D, Aagaard, Bitten, Borges, Álvaro H D, Cozzi-Lepri, Alessandro, Eid, Marius, Jansson, Per O, Jeppesen, Marianne, Joensen, Zillah Maria, Pedersen, Ruth Kjærgaard, Lundgren, Jens, Nielsen, Birgit Riis, Pearson, Mary, Peters, Lars, Qvist, Tavs, Angus, Brian, Babiker, Abdel, Bennett, Rachel, Braimah, Nafisah, Collaco-Moraes, Yolanda, Cursley, Adam, Hudson, Fleur, Pett, Sarah, Russell, Charlotte, Webb, Helen, Carey, Dianne, Courtney-Rodgers, David, Emery, Sean, Shaw, Pamela, Gordin, Fred, Sanchez, Adriana, Standridge, Barbara, Vjecha, Michael, Brekke, Kate, Campbell, Megan, Denning, Eileen, DuChene, Alain, Engen, Nicole, George, Michelle, Harrison, Merrie, Neaton, James D, Nelson, Ray, Quan, Siu-Fun, Schultz, Terri, Wentworth, Deborah, Baxter, John, Brown, Shawn, Hoover, Marie, Beigel, John, Davey, Richard T, Jr., Dewar, Robin, Gover, Erin, McConnell, Rose, Metcalf, Julia, Natarajan, Ven, Rehman, Tauseef, Voell, Jocelyn, Dwyer, Dominic E, Kok, Jen, Uyeki, Timothy M, Munroe, David, Aguila, Damian, Alzogaray, Maria Fernanda, Ballesteros, Maria Fernanda, Barcan, Laura, Barcelona, Laura, Belloso, Waldo, Berdiñas, Veronica, Bonvehi, Pablo, Caeiro, Juan Pablo, Cisneros, Veronica, Crinejo, Ana, David, Daniel, Doldan, Luz, Ebenrstejin, Juan, Lipari, Flavio, Lopardo, Ana, Lopardo, Gustavo, Losso, Marcelo, Lucchetti, Pablo, Lupo, Sergio, Macias, Laura Moreno, de Tesco, Alejandra Moricz, Mykietiuk, Analia, Nannini, Estaban, Nieto, Gabriel, Nieto, Laura, Peroni, Luciana, Retta, Ignacio, Rodriguez, Patricia, Sanchez, Marisa, Sanchez, Pablo, de Paz Sierra, Mariana, Tavella, Silvina, Temporiti, Elena, Trape, Liliana, Vieni, Ines, Warley, Eduardo, Yahni, Diego, Zarate, Abel Humberto, Avihingsanon, Anchalee, Charoentonpuban, Kanlaya, Chetchotisakd, Ploenchan, Kaewon, Peeraporn, Laopraynak, Naphassanant, Manosuthi, Weerawat, Pussadee, Kanitta, Putcharoen, Opass, Ruxrungtham, Kiat, Suwanpimonkul, Gompol, Ubolyam, Sasiwimol, Arduino, Roberto, Atkinson, Barbara, Aulicino, Taryn M, Baker, Jason V, Bardascino, Cindy, Bass, Caitlin, Baxter, John D, Beilke, Mark, Bentley, Beverly D, Lee Bertrand, Mary, Brown, Ann B, Carbonneau, June, Cindrich, Richard, Coburn, Patty, Cohen, Calvin J, Clark, Linda, Cummins, Shirley, Dassow, Paul, DeHovitz, Jack A, Dharan, Nila J, Faber, Leslie, Farrough, Marti, Freiberg, Matthew, Gardner, Edward, Jo Garrett, Kimberly, Geisler, Christiane, Glesby, Marshall, Green, Julia, Grenade, Joanne, Gunderson, Edie, Gunter, John, Ham, Kirsis, Holman, Susan, Hughes, Valery, Hurt, Christopher, Johnson, Mary, Koerbel, Glory, Koletar, Susan, Lan, Audrey, MacArthur, Rodger, Marcus, Cheryl, Markowitz, Norm, Martinez, Maria Laura, McLaughlin, Karen, Nahra, Raquel, Nettles, Mary Jane, Nixon, Daniel, Novak, Richard, Nuffer, Kathleen, Olivet, Hannah B, Omotosho, Bola, Paez, Armando P, Paez-Quinde, Marta, Parker, Sonija, Patil, Namrata, Polenakovik, Hari, Powell, Sandra, Prosser, Rachel A, Reilly, Nancy A, Riska, Paul F, Rizza, Stacey, Schooley, Robert, Schwarber, Marla, Scott, James, Simon, Gary L, Sivoravong, Jon, Skiest, Daniel J, Solorzano, Clemencia, Sondengam, Rita, Swanson, Nicole, Tedaldi, Ellen, Temesgen, Zelalem, Thomas, Doug, Thron, Bill, Traverse, Colleen, Uddin, David E, Uslan, Daniel Z, Vasco, Marina, Vaughan, William M, Vecino, Isabel, Wade, Barbara, Walker, Catrice, Watson, Kathy, Watson, Vicky, Wohl, David, Wolfe, Cameron R, Andry, Leslie, Bielen, Mireille, Clumeck, Nathan, Florence, Eric, Kabeya, Kabamba, Sagaer, Jolanthe, Weckx, Jozef, Anagnostou, Olga, Antoniadou, Anastasia, Daikos, George, Gioukari, Vicky, Kalomenidis, Ioannis, Kantzanou, Maria, Koratzanis, Georgios, Koulouris, Nikolaos, Maltezos, Efstratios, Metallidis, Symeon, Polixronopoulos, Vlassis, Sambatakou, Helen, Skoutelis, Athanasios, Touloumi, Giota, Vasilopoulos, Nikolaos, Bloch, Mark, Cunningham, Nicky, Dwyer, Dominic E, Edwards, Sian, Elliott, Julian, Garlick, Jill, Habel, Philip, Kilkenny, Fiona, Lau, Helen, MacRae, Karen, McBride, John, Moore, Richard, Prone, Isabel, Ram, Ristila, Richmond, Sue, Roth, Norm, Meng Soo, Tuck, Jo-Anne, Thompson, Vincent, Trina, Vlakahis, Emanuel, Woolstencroft, Rachel, Chadwick, David, Clarke, Tristan, Democratis, Jane, Dockrell, David, Heyderman, Robert, Jeffs, Ben, Kutter, Stefan, Llewelyn, Martin, Minton, Jane, Newport, Melanie, Price, Ashley, Benites, Carlos, Castillo, Raul, Chinchay, Romina, Cornelio, Eva, Guevara, Maria, Gutierrez, Luis, Hidalgo, Jose, La Rosa, Alberto, Pinedo, Yvett, Saenz, Maria, Vega, Juan, Baadegaard, Bente, Bach, Karen, Collins, Philippa, Gerstoft, Jan, Hergens, Lene, Jensen, Lene Pors, Joensen, Zillah Maria, Kronborg, Gitte, Loftheim, Iben Rose, Nielsen, Henrik, Oestergaard, Lars, Pedersen, Court, Stauning Pedersen, Jens Aage, Yehdego, Yordanos, Bergmann, Frank, Boesecke, Christoph, Bogner, Johannes R, Brockmeyer, Norbert, Czaja-Harder, Christine, Draenert, Rika, Fätkenheuer, Gerd, Klinker, Hartwig, Kümmerle, Tim, Lehmann, Clara, Müller, Vera, Plettenberg, Andreas, Rockstroh, Jürgen, Schlabe, Stefan, E Schmidt, Wolfgang, Schürmann, Dirk, Schüttfort, Gundolf, Seybold, Ulrich, Stephan, Christoph, Stoehr, Albrecht, Tillmann, Klaus, Wiebecke, Susanne, Wolf, Timo, Arribas, Jose, Carbone, Javier, Fernández Cruz, Eduardo, Dalmau, David, Estrada, Vincente, Herrero, Patricia, Knobel, Hernando, López, Paco, Montejano, Rocío, Sans Moreno, José, Ramón Paño, José, Portas, Begoña, Rodrigo, Maria, Romero, Pilar, Sánchez-Sendín, Domingo, Soriano, Vincente, Bakowska, Elzbieta, Horban, Andrzej Jerzy, Knysz, Brygida, Kowalska, Karolina Pyziak, Zubkiewicz-Zarebska, Anna, Kase, Kerstin, Mülle, Helen, Zilmer, Kai, Allendes, Gladys, Flores, Jimena, Northland, Rebeka, Perez, Carlos, Velasco, Isabel, Wolff, Marcelo, Chu, Man-Yee, Wu, Tak-chiu, Burgmann, Heinz, Tobudic, Selma, Imahashi, Mayumi, Imamura, Junji, Iwatani, Yasumasa, Kogure, Ayumi, Nakahata, Masashi, Sugiura, Wataru, Yokomaku, Yoshiyuki, and Maagaard, Anne

Published
2017
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5. Antiretroviral-naïve HIV-infected patients had lower bone formation markers than HIV-uninfected adults.

Author

Wattanachanya, Lalita, Jantrapakde, Jureeporn, Avihingsanon, Anchalee, Ramautarsing, Reshmie, Kerr, Stephen, Trachunthong, Deondara, Pussadee, Kanitta, Teeratakulpisarn, Nipat, Jadwattanakul, Tanate, Chaiwatanarat, Tawatchai, Buranasupkajorn, Patinut, Phanuphak, Nittaya, Sunthornyothin, Sarat, and Phanuphak, Praphan

Subjects
PEPTIDE analysis, BIOMARKERS, BONE growth, COLLAGEN, COMPARATIVE studies, DENSITOMETRY, HIP joint, HIV infections, HIV-positive persons, NECK, SPINE, VITAMIN D, ANTIRETROVIRAL agents, BONE density, BODY mass index, OSTEOCALCIN, CD4 lymphocyte count
Abstract

There are limited studies regarding bone health among people living with HIV (PLHIV) in Asia. We compared bone mineral density (BMD), serum 25-hydroxyvitamin D (25(OH)D) status and bone turnover markers (serum procollagen type1 N-terminal propeptide (P1NP), osteocalcin (OC) and C-terminal cross-linking telopeptide of type1 collagen) among 302 antiretroviral therapy (ART) naive PLHIV compared to 269 HIV-uninfected controls from Thailand. People aged ≥30 years, with and without HIV infection (free of diabetes, hypertension, and active opportunistic infection) were enrolled. BMD at the lumbar spine, total hip, and femoral neck were measured using Hologic DXA at baseline and at 5 years. We analyzed BMD, serum 25(OH)D levels, and bone turnover markers at the patients' baseline visit. PLHIV were 1.5 years younger and had lower BMI. PLHIV had higher mean serum 25(OH)D level and similar BMD to the controls. Interestingly, PLHIV had significantly lower bone formation (serum P1NP and OC), particularly those with low CD4 count. Only a few participants had low bone mass. ARV naïve middle-aged PLHIV did not have lower BMD or lower vitamin D levels compared to the controls. However, PLHIV had lower bone formation markers, particularly those with low CD4 count. This finding supports the benefit of early ART. [ABSTRACT FROM AUTHOR]

Published
2020
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6. Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study – PEDA Study.

Author

Sapsirisavat, Vorapot, Vongsutilers, Vorasit, Thammajaruk, Narukjaporn, Pussadee, Kanitta, Riyaten, Prakit, Kerr, Stephen, Avihingsanon, Anchalee, Phanuphak, Praphan, Ruxrungtham, Kiat, and null, null

Subjects
HIV infections, THERAPEUTICS, MEDICATION safety, DRUG efficacy, ANTIRETROVIRAL agents, GENERIC drugs
Abstract

Objectives: Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. Methods: We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia. Results: A total of 42 batches of ARV from 15 sources were sampled from January–March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription. Conclusion: Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity along the HIV treatment and care cascade is available. [ABSTRACT FROM AUTHOR]

Published
2016
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