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1. Long-term efficacy and safety of a treatment strategy for HIV infection using protease inhibitor monotherapy: 8-year routine clinical care follow-up from a randomised, controlled, open-label pragmatic trial (PIVOT)Research in context

Author

Nicholas I. Paton, Wolfgang Stöhr, Alejandro Arenas-Pinto, Amanda Clarke, Ian Williams, Margaret Johnson, Chloe Orkin, Fabian Chen, Vincent Lee, Alan Winston, Mark Gompels, Julie Fox, Karen Sanders, David T. Dunn, Martin Fisher, Wendy Hadley, David Stacey, Pat Byrne, Nahum De Esteban, Pierre Pellegrino, Lewis Haddow, James Hand, Carl De Souza, Lisa Murthen, Andrew Crawford-Jones, Ruth Wilson, Elizabeth Green, John Masterson, Kamlesh Patel, Rebecca Howe, Scott Mullaney, Louise Jennings, Nicholas Beeching, Rebecca Tamaklo, Alistair Teague, Isabelle Jendrulek, Juan Manuel Tiraboschi, Ed Wilkins, Yvonne Clowes, Andrew Thompson, Gary Brook, Manoj Trivedi, Kazeem Aderogba, Martin Jones, Andrew DeBurgh-Thomas, Liz Jones, Iain Reeves, Sifiso Mguni, David Chadwick, Pauline Spence, Nellie Nkhoma, Zoe Warwick, Suzanne Price, Sally Read, Elbushra Herieka, James Walker, Ruth Woodward, John Day, Laura Hilton, Veerakathy Harinda, Helen Blackman, Phillip Hay, Wendy Mejewska, Olanike Okolo, Edmund Ong, Karen Martin, Lee Munro, David Dockrell, Lynne Smart, Jonathan Ainsworth, Anele Waters, Stephen Kegg, Sara McNamara, Steve Taylor, Gerry Gilleran, Brian Gazzard, Jane Rowlands, Sris Allan, Rumun Sandhu, Nigel O'Farrell, Sheena Quaid, Fabiola Martin, Caroline Bennett, Moses Kapembwa, Jane Minton, James Calderwood, Frank Post, Lucy Campbell, Emily Wandolo, Adrian Palfreeman, Linda Mashonganyika, Thambiah Balachandran, Memory Kakowa, Rebecca O'Connell, Cheryl Tanawa, Sinna Jebakumar, Lesley Hagger, Say Quah, Sinead McKernan, Charles Lacey, Sarah Douglas, Sarah Russell-Sharpe, Christine Brewer, Clifford Leen, Sheila Morris, Sharmin Obeyesekera, Shirley Williams, Nelson David, Mark Roberts, Julie Wollaston, Nicholas Paton, Karen Scott, David Dunn, Emma Beaumont, Sue Fleck, Mark Hall, Susie Hennings, Ischa Kummeling, Sara Martins, Ellen Owen-Powell, Fionna van Hooff, Livia Vivas, Ellen White, Brian Angus, Andrew Freedman, Ben Cromerty, Danielle Mercey, Sarah Fidler, Estee Torok, Abdel Babiker, Tim Peto, David Lalloo, Andrew Phillips, and Robert James

Subjects
HIV, Randomised, Protease inhibitor monotherapy, Simplification, Darunavir, Medicine (General), R5-920
Abstract

Summary: Background: Treatment-simplification strategies are important tools for patient-centred management. We evaluated long-term outcomes from a PI monotherapy switch strategy. Methods: Eligible participants attending 43 UK treatment centres had a viral load (VL) below 50 copies/ml for at least 24 weeks on combination ART. Participants were randomised to maintain ongoing triple therapy (OT) or switch to a strategy of physician-selected PI monotherapy (PI-mono) with prompt return to combination therapy if VL rebounded. The primary outcome, previously reported, was loss of future drug options after 3 years, defined as new intermediate/high level resistance to at least one drug to which the participant's virus was considered sensitive at trial entry. Here we report resistance and disease outcomes after further extended follow-up in routine care. The study was registered as ISRCTN04857074. Findings: We randomised 587 participants to OT (291) or PI-mono (296) between Nov 4, 2008, and July 28, 2010 and followed them for a median of more than 8 years (100 months) until 2018. At the end of this follow-up time, one or more future drug options had been lost in 7 participants in the OT group and 6 in the PI-mono group; estimated cumulative risk by 8 years of 2.7% and 2.1% respectively (difference −0.6%, 95% CI −3.2% to 2.0%). Only one PI-mono participant developed resistance to the protease inhibitor they were taking (atazanavir). Serious clinical events (death, serious AIDS, and serious non-AIDS) were infrequent; reported in a total of 12 (4.1%) participants in the OT group and 23 (7.8%) in the PI-mono group (P = 0.08) over the entire follow-up period. Interpretation: A strategy of PI monotherapy, with regular VL monitoring and prompt reintroduction of combination treatment following rebound, preserved future treatment options. Findings confirm the high genetic barrier to resistance of the PI drug class that makes them well suited for creative, patient-centred, treatment-simplification approaches. The possibility of a small excess risk of serious clinical events with the PI monotherapy strategy cannot be excluded. Funding: The National Institute for Health Research Health Technology Assessment programme.

Published
2024
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2. Long-term efficacy and safety of a treatment strategy for HIV infection using protease inhibitor monotherapy: 8-year routine clinical care follow-up from a randomised, controlled, open-label pragmatic trial (PIVOT)

Author

Fisher, Martin, Clarke, Amanda, Hadley, Wendy, Stacey, David, Johnson, Margaret, Byrne, Pat, Williams, Ian, De Esteban, Nahum, Pellegrino, Pierre, Haddow, Lewis, Arenas-Pinto, Alejandro, Orkin, Chloe, Hand, James, De Souza, Carl, Murthen, Lisa, Crawford-Jones, Andrew, Chen, Fabian, Wilson, Ruth, Green, Elizabeth, Masterson, John, Lee, Vincent, Patel, Kamlesh, Howe, Rebecca, Winston, Alan, Mullaney, Scott, Gompels, Mark, Jennings, Louise, Beeching, Nicholas, Tamaklo, Rebecca, Fox, Julie, Teague, Alistair, Jendrulek, Isabelle, Tiraboschi, Juan Manuel, Wilkins, Ed, Clowes, Yvonne, Thompson, Andrew, Brook, Gary, Trivedi, Manoj, Aderogba, Kazeem, Jones, Martin, DeBurgh-Thomas, Andrew, Jones, Liz, Reeves, Iain, Mguni, Sifiso, Chadwick, David, Spence, Pauline, Nkhoma, Nellie, Warwick, Zoe, Price, Suzanne, Read, Sally, Herieka, Elbushra, Walker, James, Woodward, Ruth, Day, John, Hilton, Laura, Harinda, Veerakathy, Blackman, Helen, Hay, Phillip, Mejewska, Wendy, Okolo, Olanike, Ong, Edmund, Martin, Karen, Munro, Lee, Dockrell, David, Smart, Lynne, Ainsworth, Jonathan, Waters, Anele, Kegg, Stephen, McNamara, Sara, Taylor, Steve, Gilleran, Gerry, Gazzard, Brian, Rowlands, Jane, Allan, Sris, Sandhu, Rumun, O'Farrell, Nigel, Quaid, Sheena, Martin, Fabiola, Bennett, Caroline, Kapembwa, Moses, Minton, Jane, Calderwood, James, Post, Frank, Campbell, Lucy, Wandolo, Emily, Palfreeman, Adrian, Mashonganyika, Linda, Balachandran, Thambiah, Kakowa, Memory, O'Connell, Rebecca, Tanawa, Cheryl, Jebakumar, Sinna, Hagger, Lesley, Quah, Say, McKernan, Sinead, Lacey, Charles, Douglas, Sarah, Russell-Sharpe, Sarah, Brewer, Christine, Leen, Clifford, Morris, Sheila, Obeyesekera, Sharmin, Williams, Shirley, David, Nelson, Roberts, Mark, Wollaston, Julie, Paton, Nicholas, Stöhr, Wolfgang, Scott, Karen, Dunn, David, Beaumont, Emma, Fleck, Sue, Hall, Mark, Hennings, Susie, Kummeling, Ischa, Martins, Sara, Owen-Powell, Ellen, Sanders, Karen, van Hooff, Fionna, Vivas, Livia, White, Ellen, Angus, Brian, Freedman, Andrew, Cromerty, Ben, Mercey, Danielle, Fidler, Sarah, Torok, Estee, Babiker, Abdel, Peto, Tim, Lalloo, David, Phillips, Andrew, James, Robert, Paton, Nicholas I., and Dunn, David T.

Published
2024
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3. Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV

Author

Moore, Amelia E.B., Burns, James E., Sally, Deirdre, Milinkovic, Ana, Krokos, Georgios, John, Joemon, Rookyard, Christopher, Borca, Alessandro, Pool, Erica R.M., Tostevin, Anna, Harman, Alyss, Dulnoan, Dwight S., Gilson, Richard, Arenas-Pinto, Alejandro, Cook, Gary J.R., Saunders, John, Dunn, David, Blake, Glen M., and Pett, Sarah L.

Published
2024
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4. Effect of second booster vaccinations and prior infection against SARS-CoV-2 in the UK SIREN healthcare worker cohort

Author

Lewis, Tracy, Bain, Steve, Thomas, Rebeccah, Geen, John, Pothecary, Carla, Cutler, Sean, Northfield, John, Price, Cathy, Tomlinson, Johanne, Knight, Sarah, Macnaughton, Emily, Watson, Ekaterina, Lazarus, Rajeka, Sinclair, Aaran, Galliford, Joanne, Masunda, Bridgett, Mahungu, Tabitha, Rodger, Alison, Hanison, Esther, Warren, Simon, Jain, Swati, Mirfenderesky, Mariyam, Mahabir, Natasha, Pritchard-Jones, Rowan, Wycherley, Diane, Gabriel, Claire, Matovu, Elijah, Bakker, Philippa, Guha, Simantee, Gormley, S., Pethick, James, Butt, Georgina, Pepper, Stacey, Bedford, Luke, Ridley, Paul, Democratis, Jane, Meda, Manjula, Chawla, Anu, Westwell, Fran, Kalakonda, Nagesh, Khanduri, Sheena, Doel, Allison, Pai, Sumita, Hacon, Christian, Nwaka, Davis, Moro, Veronica Mendez, Moody, A., Auckland, Cressida, Prince, Stephanie, de Silva, Thushan, Shulver, Helen, Shah, A., Jones, C., Subhro-Osuji, Banerjee, Houston, Angela, Planche, Tim, Booth, Martin, Duff, Christopher, Aeron-Thomas, Jonnie, Chaudhuri, Ray, Hilton, David, Jory, Hannah, Al-Khafaji, Zehra'a, Kemsley, Philippa, Longfellow, Ruth, Boss, David, Brake, Simon, Coke, Louise, Elumogo, Ngozi, Latham, Scott, Subudhi, Chinari, Hoad, Ina, Thomas, Claire, Chitalia, Nihil, Edmunds, Tracy, Ashby, Helen, Elliott, John, Wilkinson, Beverley, Rand, Abby, Thompson, Catherine, Agwuh, K., Grice, Anna, Moran, Kelly, Waykar, Vijayendra, Lester, Yvonne, Sach, Lauren, Court, Kathryn, White, Nikki, Favager, Clair, Holliday, Kyra, Harwood, Jayne, Payne, Brendan, Burns, Karen, Fothergill, Lynda, Arenas-Pinto, Alejandro, Severn, Abigail, Brown, Kerryanne, Gray, Katherine, Dare, Jane, Zheng, Qi, Hollinshead, Kathryn, Shorten, Robert, Roebuck, Alun, Holmes, Christopher, Wiselka, Martin, Faris, Barzo, Marsh, Liane, McAdam, Clare, Ditchfield, Lisa, Qazzafi, Zaman, Boyd, G., Wong, N., Brand, Sarah, Squires, Jack, Ashcroft, John, Rosario, Ismaelette Del, Howard, Joanne, Ward, Emma, Harrison, Gemma, Morgan, Joely, Corless, Claire, Penn, Ruth, Wong, Nick, Bagary, Manny, Starkova, Nadezda, Beekes, Mandy, Carnahan, Mandy, Khan, Shivani, Mackay, Shekoo, Lewis, Keneisha, Pickard, Graham, Dawson, Joy, Finlayson, Lauren, Cameron, Euan, Todd, Anne, Fagegaltier, Sebastien, Mavin, Sally, Cochrane, Alexandra, Gibson, Andrew, Donaldson, Sam, Templeton, Kate, Malcolm, Martin, Smith, Beth, Dhasmana, Devesh, Fowler, Susan, Ho, Antonia, Murphy, Michael, Beith, Claire, Patel, Manish, Boyd, Elizabeth, Irvine, Val, Grant, Alison, Temple-Purcell, Rebecca, Loughrey, Clodagh, Hanna, Elinor, Johnston, Frances, Boulos, Angel, Thompson, Fiona, Protaschik, Yuri, Regan, Susan, Donaghy, Tracy, O'Kane, Maurice, Akinbami, Omolola, Barbero, Paola, Brooks, Tim, Chand, Meera, Insalata, Ferdinando, Joshi, Palak, O'Connell, Anne-Marie, Ramsay, Mary, Saei, Ayoub, Zambon, Maria, Linley, Ezra, Tonge, Simon, Adaji, Enemona, Adebiyi, Omoyeni, Andrews, Nick, Conneely, Joanna, Conneely, Paul, Dunne, Angela, Dyer, Simone, Emmett, Hannah, Hettiarachchi, Nipunadi, Kapirial, Nishanthan, Khawam, Jameel, Monk, Edward, Russell, Sophie, Taylor-Kerr, Andrew, Timeyin, Jean, D'Arcangelo, Silvia, Rowe, Cathy, Semper, Amanda, Gallagher, Eileen, Kyffin, Robert, Cromey, Lisa, Areghan, Desmond, Bishop, Jennifer, Dembinsky, Melanie, Dobbie, Laura, Evans, Josie, Goldberg, David, Haahr, Lynne, Jorgenson, Annelysse, Matuluko, Ayodeji, Naismith, Laura, Nuryunarsih, Desy, Olaoye, Alexander, Plank, Caitlin, Price, Lesley, Sergenson, Nicole, Stewart, Sally, Telfer, Andrew, Weir, Jennifer, De Lacy, Ellen, Ellis, Yvette, Froude, Susannah, Stevens, Guy, Tyson, Linda, Dunachie, Susanna, Klenerman, Paul, Duncan, Chris, Payne, Rebecca, Turtle, Lance, Richter, Alex, De Silva, Thushan, Barnes, Eleanor, Wootton, Daniel, Galgut, Oliver, Heeney, Jonathan, Baxendale, Helen, Castillo-Olivares, Javier, Beale, Rupert, Carr, Edward, Barclay, Wendy, Moshe, Maya, Palmarini, Massimo, Willett, Brian, Baillie, John Kenneth, Evans, Jennie, Aquino, Erika, Kirwan, Peter D., Hall, Victoria J., Foulkes, Sarah, Otter, Ashley D., Munro, Katie, Sparkes, Dominic, Howells, Anna, Platt, Naomi, Broad, Jonathan, Crossman, David, Norman, Chris, Corrigan, Diane, Jackson, Christopher H., Cole, Michelle, Brown, Colin S., Atti, Ana, Islam, Jasmin, Presanis, Anne M., Charlett, Andre, De Angelis, Daniela, and Hopkins, Susan

Published
2024
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5. Effect of second booster vaccinations and prior infection against SARS-CoV-2 in the UK SIREN healthcare worker cohortResearch in context

Author

Peter D. Kirwan, Victoria J. Hall, Sarah Foulkes, Ashley D. Otter, Katie Munro, Dominic Sparkes, Anna Howells, Naomi Platt, Jonathan Broad, David Crossman, Chris Norman, Diane Corrigan, Christopher H. Jackson, Michelle Cole, Colin S. Brown, Ana Atti, Jasmin Islam, Anne M. Presanis, Andre Charlett, Daniela De Angelis, Susan Hopkins, Tracy Lewis, Steve Bain, Rebeccah Thomas, John Geen, Carla Pothecary, Sean Cutler, John Northfield, Cathy Price, Johanne Tomlinson, Sarah Knight, Emily Macnaughton, Ekaterina Watson, Rajeka Lazarus, Aaran Sinclair, Joanne Galliford, Bridgett Masunda, Tabitha Mahungu, Alison Rodger, Esther Hanison, Simon Warren, Swati Jain, Mariyam Mirfenderesky, Natasha Mahabir, Rowan Pritchard-Jones, Diane Wycherley, Claire Gabriel, Elijah Matovu, Philippa Bakker, Simantee Guha, S. Gormley, James Pethick, Georgina Butt, Stacey Pepper, Luke Bedford, Paul Ridley, Jane Democratis, Manjula Meda, Anu Chawla, Fran Westwell, Nagesh Kalakonda, Sheena Khanduri, Allison Doel, Sumita Pai, Christian Hacon, Davis Nwaka, Veronica Mendez Moro, A. Moody, Cressida Auckland, Stephanie Prince, Thushan de Silva, Helen Shulver, A. Shah, C. Jones, Banerjee Subhro-Osuji, Angela Houston, Tim Planche, Martin Booth, Christopher Duff, Jonnie Aeron-Thomas, Ray Chaudhuri, David Hilton, Hannah Jory, Zehra'a Al-Khafaji, Philippa Kemsley, Ruth Longfellow, David Boss, Simon Brake, Louise Coke, Ngozi Elumogo, Scott Latham, Chinari Subudhi, Ina Hoad, Claire Thomas, Nihil Chitalia, Tracy Edmunds, Helen Ashby, John Elliott, Beverley Wilkinson, Abby Rand, Catherine Thompson, K. Agwuh, Anna Grice, Kelly Moran, Vijayendra Waykar, Yvonne Lester, Lauren Sach, Kathryn Court, Nikki White, Clair Favager, Kyra Holliday, Jayne Harwood, Brendan Payne, Karen Burns, Lynda Fothergill, Alejandro Arenas-Pinto, Abigail Severn, Kerryanne Brown, Katherine Gray, Jane Dare, Qi Zheng, Kathryn Hollinshead, Robert Shorten, Alun Roebuck, Christopher Holmes, Martin Wiselka, Barzo Faris, Liane Marsh, Clare McAdam, Lisa Ditchfield, Zaman Qazzafi, G. Boyd, N. Wong, Sarah Brand, Jack Squires, John Ashcroft, Ismaelette Del Rosario, Joanne Howard, Emma Ward, Gemma Harrison, Joely Morgan, Claire Corless, Ruth Penn, Nick Wong, Manny Bagary, Nadezda Starkova, Mandy Beekes, Mandy Carnahan, Shivani Khan, Shekoo Mackay, Keneisha Lewis, Graham Pickard, Joy Dawson, Lauren Finlayson, Euan Cameron, Anne Todd, Sebastien Fagegaltier, Sally Mavin, Alexandra Cochrane, Andrew Gibson, Sam Donaldson, Kate Templeton, Martin Malcolm, Beth Smith, Devesh Dhasmana, Susan Fowler, Antonia Ho, Michael Murphy, Claire Beith, Manish Patel, Elizabeth Boyd, Val Irvine, Alison Grant, Rebecca Temple-Purcell, Clodagh Loughrey, Elinor Hanna, Frances Johnston, Angel Boulos, Fiona Thompson, Yuri Protaschik, Susan Regan, Tracy Donaghy, Maurice O'Kane, Omolola Akinbami, Paola Barbero, Tim Brooks, Meera Chand, Ferdinando Insalata, Palak Joshi, Anne-Marie O'Connell, Mary Ramsay, Ayoub Saei, Maria Zambon, Ezra Linley, Simon Tonge, Enemona Adaji, Omoyeni Adebiyi, Nick Andrews, Joanna Conneely, Paul Conneely, Angela Dunne, Simone Dyer, Hannah Emmett, Nipunadi Hettiarachchi, Nishanthan Kapirial, Jameel Khawam, Edward Monk, Sophie Russell, Andrew Taylor-Kerr, Jean Timeyin, Silvia D'Arcangelo, Cathy Rowe, Amanda Semper, Eileen Gallagher, Robert Kyffin, Lisa Cromey, Desmond Areghan, Jennifer Bishop, Melanie Dembinsky, Laura Dobbie, Josie Evans, David Goldberg, Lynne Haahr, Annelysse Jorgenson, Ayodeji Matuluko, Laura Naismith, Desy Nuryunarsih, Alexander Olaoye, Caitlin Plank, Lesley Price, Nicole Sergenson, Sally Stewart, Andrew Telfer, Jennifer Weir, Ellen De Lacy, Yvette Ellis, Susannah Froude, Guy Stevens, Linda Tyson, Susanna Dunachie, Paul Klenerman, Chris Duncan, Rebecca Payne, Lance Turtle, Alex Richter, Thushan De Silva, Eleanor Barnes, Daniel Wootton, Oliver Galgut, Jonathan Heeney, Helen Baxendale, Javier Castillo-Olivares, Rupert Beale, Edward Carr, Wendy Barclay, Maya Moshe, Massimo Palmarini, Brian Willett, John Kenneth Baillie, Jennie Evans, and Erika Aquino

Subjects
SARS-CoV-2, Vaccine effectiveness, Asymptomatic, Symptomatic, Healthcare worker, Cohort study, Public aspects of medicine, RA1-1270
Abstract

Summary: Background: The protection of fourth dose mRNA vaccination against SARS-CoV-2 is relevant to current global policy decisions regarding ongoing booster roll-out. We aimed to estimate the effect of fourth dose vaccination, prior infection, and duration of PCR positivity in a highly-vaccinated and largely prior-COVID-19 infected cohort of UK healthcare workers. Methods: Participants underwent fortnightly PCR and regular antibody testing for SARS-CoV-2 and completed symptoms questionnaires. A multi-state model was used to estimate vaccine effectiveness (VE) against infection from a fourth dose compared to a waned third dose, with protection from prior infection and duration of PCR positivity jointly estimated. Findings: 1298 infections were detected among 9560 individuals under active follow-up between September 2022 and March 2023. Compared to a waned third dose, fourth dose VE was 13.1% (95% CI 0.9 to 23.8) overall; 24.0% (95% CI 8.5 to 36.8) in the first 2 months post-vaccination, reducing to 10.3% (95% CI −11.4 to 27.8) and 1.7% (95% CI −17.0 to 17.4) at 2–4 and 4–6 months, respectively. Relative to an infection >2 years ago and controlling for vaccination, 63.6% (95% CI 46.9 to 75.0) and 29.1% (95% CI 3.8 to 43.1) greater protection against infection was estimated for an infection within the past 0–6, and 6–12 months, respectively. A fourth dose was associated with greater protection against asymptomatic infection than symptomatic infection, whilst prior infection independently provided more protection against symptomatic infection, particularly if the infection had occurred within the previous 6 months. Duration of PCR positivity was significantly lower for asymptomatic compared to symptomatic infection. Interpretation: Despite rapid waning of protection, vaccine boosters remain an important tool in responding to the dynamic COVID-19 landscape; boosting population immunity in advance of periods of anticipated pressure, such as surging infection rates or emerging variants of concern. Funding: UK Health Security Agency, Medical Research Council, NIHR HPRU Oxford, Bristol, and others.

Published
2024
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6. Depression is associated with poor self-reported adherence to antiretroviral therapy among people living with HIV attending an HIV clinic in the UK: results from a cross-sectional study.

Author

Paredes, Jose Luis, Arenas-Pinto, Alejandro, McAlpine, Connor, Matthews, Rebecca, Milinkovic, Ana, and Suonpera, Emmi

Subjects
*SELF-evaluation, *PATIENT compliance, *CROSS-sectional method, *SUBSTANCE abuse, *ANTIRETROVIRAL agents, *SECONDARY analysis, *QUESTIONNAIRES, *UNEMPLOYMENT, *HIV infections, *AGE distribution, *DESCRIPTIVE statistics, *PSYCHOLOGY of HIV-positive persons, *HEALTH behavior, *DRUGS, *CLINICS, *MEDICAL screening, *ALCOHOL drinking, *MENTAL depression, *SEXUAL health, *PSYCHOSOCIAL factors
Abstract

Contemporary evidence is needed to assess whether the prevalence of depression remains high among people living with HIV in the United Kingdom despite recent efforts to improve patients' mental health, and if depression is negatively associated with individuals' adherence to antiretroviral therapy. In a secondary analysis of a cross-sectional clinic-based survey of alcohol consumption and associated health behaviour among people living with HIV in London, of the 221 respondents, 106 (48%) had poor self-reported adherence to antiretroviral therapy (CASE Index) and 69 (31%) screened positive for depression (PHQ-9). Poor self-reported adherence to ART was 72% higher among participants who screened positive for depression in comparison with participants who screened negative. Respondents who were younger, unemployed, and reported problematic drug use were more likely to screen positive for depression. Screening and management of depression as a part of routine HIV care may support adherence to antiretroviral therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Effect of second booster vaccinations and prior infection against SARS-CoV-2 in the UK SIREN healthcare worker cohort

Author

Kirwan, Peter D., primary, Hall, Victoria J., additional, Foulkes, Sarah, additional, Otter, Ashley D., additional, Munro, Katie, additional, Sparkes, Dominic, additional, Howells, Anna, additional, Platt, Naomi, additional, Broad, Jonathan, additional, Crossman, David, additional, Norman, Chris, additional, Corrigan, Diane, additional, Jackson, Christopher H., additional, Cole, Michelle, additional, Brown, Colin S., additional, Atti, Ana, additional, Islam, Jasmin, additional, Presanis, Anne M., additional, Charlett, Andre, additional, De Angelis, Daniela, additional, Hopkins, Susan, additional, Lewis, Tracy, additional, Bain, Steve, additional, Thomas, Rebeccah, additional, Geen, John, additional, Pothecary, Carla, additional, Cutler, Sean, additional, Northfield, John, additional, Price, Cathy, additional, Tomlinson, Johanne, additional, Knight, Sarah, additional, Macnaughton, Emily, additional, Watson, Ekaterina, additional, Lazarus, Rajeka, additional, Sinclair, Aaran, additional, Galliford, Joanne, additional, Masunda, Bridgett, additional, Mahungu, Tabitha, additional, Rodger, Alison, additional, Hanison, Esther, additional, Warren, Simon, additional, Jain, Swati, additional, Mirfenderesky, Mariyam, additional, Mahabir, Natasha, additional, Pritchard-Jones, Rowan, additional, Wycherley, Diane, additional, Gabriel, Claire, additional, Matovu, Elijah, additional, Bakker, Philippa, additional, Guha, Simantee, additional, Gormley, S., additional, Pethick, James, additional, Butt, Georgina, additional, Pepper, Stacey, additional, Bedford, Luke, additional, Ridley, Paul, additional, Democratis, Jane, additional, Meda, Manjula, additional, Chawla, Anu, additional, Westwell, Fran, additional, Kalakonda, Nagesh, additional, Khanduri, Sheena, additional, Doel, Allison, additional, Pai, Sumita, additional, Hacon, Christian, additional, Nwaka, Davis, additional, Moro, Veronica Mendez, additional, Moody, A., additional, Auckland, Cressida, additional, Prince, Stephanie, additional, de Silva, Thushan, additional, Shulver, Helen, additional, Shah, A., additional, Jones, C., additional, Subhro-Osuji, Banerjee, additional, Houston, Angela, additional, Planche, Tim, additional, Booth, Martin, additional, Duff, Christopher, additional, Aeron-Thomas, Jonnie, additional, Chaudhuri, Ray, additional, Hilton, David, additional, Jory, Hannah, additional, Al-Khafaji, Zehra'a, additional, Kemsley, Philippa, additional, Longfellow, Ruth, additional, Boss, David, additional, Brake, Simon, additional, Coke, Louise, additional, Elumogo, Ngozi, additional, Latham, Scott, additional, Subudhi, Chinari, additional, Hoad, Ina, additional, Thomas, Claire, additional, Chitalia, Nihil, additional, Edmunds, Tracy, additional, Ashby, Helen, additional, Elliott, John, additional, Wilkinson, Beverley, additional, Rand, Abby, additional, Thompson, Catherine, additional, Agwuh, K., additional, Grice, Anna, additional, Moran, Kelly, additional, Waykar, Vijayendra, additional, Lester, Yvonne, additional, Sach, Lauren, additional, Court, Kathryn, additional, White, Nikki, additional, Favager, Clair, additional, Holliday, Kyra, additional, Harwood, Jayne, additional, Payne, Brendan, additional, Burns, Karen, additional, Fothergill, Lynda, additional, Arenas-Pinto, Alejandro, additional, Severn, Abigail, additional, Brown, Kerryanne, additional, Gray, Katherine, additional, Dare, Jane, additional, Zheng, Qi, additional, Hollinshead, Kathryn, additional, Shorten, Robert, additional, Roebuck, Alun, additional, Holmes, Christopher, additional, Wiselka, Martin, additional, Faris, Barzo, additional, Marsh, Liane, additional, McAdam, Clare, additional, Ditchfield, Lisa, additional, Qazzafi, Zaman, additional, Boyd, G., additional, Wong, N., additional, Brand, Sarah, additional, Squires, Jack, additional, Ashcroft, John, additional, Rosario, Ismaelette Del, additional, Howard, Joanne, additional, Ward, Emma, additional, Harrison, Gemma, additional, Morgan, Joely, additional, Corless, Claire, additional, Penn, Ruth, additional, Wong, Nick, additional, Bagary, Manny, additional, Starkova, Nadezda, additional, Beekes, Mandy, additional, Carnahan, Mandy, additional, Khan, Shivani, additional, Mackay, Shekoo, additional, Lewis, Keneisha, additional, Pickard, Graham, additional, Dawson, Joy, additional, Finlayson, Lauren, additional, Cameron, Euan, additional, Todd, Anne, additional, Fagegaltier, Sebastien, additional, Mavin, Sally, additional, Cochrane, Alexandra, additional, Gibson, Andrew, additional, Donaldson, Sam, additional, Templeton, Kate, additional, Malcolm, Martin, additional, Smith, Beth, additional, Dhasmana, Devesh, additional, Fowler, Susan, additional, Ho, Antonia, additional, Murphy, Michael, additional, Beith, Claire, additional, Patel, Manish, additional, Boyd, Elizabeth, additional, Irvine, Val, additional, Grant, Alison, additional, Temple-Purcell, Rebecca, additional, Loughrey, Clodagh, additional, Hanna, Elinor, additional, Johnston, Frances, additional, Boulos, Angel, additional, Thompson, Fiona, additional, Protaschik, Yuri, additional, Regan, Susan, additional, Donaghy, Tracy, additional, O'Kane, Maurice, additional, Akinbami, Omolola, additional, Barbero, Paola, additional, Brooks, Tim, additional, Chand, Meera, additional, Insalata, Ferdinando, additional, Joshi, Palak, additional, O'Connell, Anne-Marie, additional, Ramsay, Mary, additional, Saei, Ayoub, additional, Zambon, Maria, additional, Linley, Ezra, additional, Tonge, Simon, additional, Adaji, Enemona, additional, Adebiyi, Omoyeni, additional, Andrews, Nick, additional, Conneely, Joanna, additional, Conneely, Paul, additional, Dunne, Angela, additional, Dyer, Simone, additional, Emmett, Hannah, additional, Hettiarachchi, Nipunadi, additional, Kapirial, Nishanthan, additional, Khawam, Jameel, additional, Monk, Edward, additional, Russell, Sophie, additional, Taylor-Kerr, Andrew, additional, Timeyin, Jean, additional, D'Arcangelo, Silvia, additional, Rowe, Cathy, additional, Semper, Amanda, additional, Gallagher, Eileen, additional, Kyffin, Robert, additional, Cromey, Lisa, additional, Areghan, Desmond, additional, Bishop, Jennifer, additional, Dembinsky, Melanie, additional, Dobbie, Laura, additional, Evans, Josie, additional, Goldberg, David, additional, Haahr, Lynne, additional, Jorgenson, Annelysse, additional, Matuluko, Ayodeji, additional, Naismith, Laura, additional, Nuryunarsih, Desy, additional, Olaoye, Alexander, additional, Plank, Caitlin, additional, Price, Lesley, additional, Sergenson, Nicole, additional, Stewart, Sally, additional, Telfer, Andrew, additional, Weir, Jennifer, additional, De Lacy, Ellen, additional, Ellis, Yvette, additional, Froude, Susannah, additional, Stevens, Guy, additional, Tyson, Linda, additional, Dunachie, Susanna, additional, Klenerman, Paul, additional, Duncan, Chris, additional, Payne, Rebecca, additional, Turtle, Lance, additional, Richter, Alex, additional, De Silva, Thushan, additional, Barnes, Eleanor, additional, Wootton, Daniel, additional, Galgut, Oliver, additional, Heeney, Jonathan, additional, Baxendale, Helen, additional, Castillo-Olivares, Javier, additional, Beale, Rupert, additional, Carr, Edward, additional, Barclay, Wendy, additional, Moshe, Maya, additional, Palmarini, Massimo, additional, Willett, Brian, additional, Baillie, John Kenneth, additional, Evans, Jennie, additional, and Aquino, Erika, additional

Published
2024
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8. Hepatic steatosis in people older and younger than fifty who are living with HIV and HIV‐negative controls: A cross‐sectional study nested within the POPPY cohort.

Author

Arenas‐Pinto, Alejandro, Bakewell, Nicholas, Milinkovic, Ana, Williams, Ian, Vera, Jaime, Post, Frank A., Anderson, Jane, Beynon, Michelle, O'Brien, Alastair, Doyle, Nicki, Gilson, Richard, Pett, Sarah L., Winston, Alan, and Sabin, Caroline A.

Subjects
*HIV-positive persons, *KRUSKAL-Wallis Test, *ULTRASONIC imaging, *CONFIDENCE intervals, *FATTY liver, *CROSS-sectional method, *FISHER exact test, *RISK assessment, *COMPARATIVE studies, *WAIST-hip ratio, *RESEARCH funding, *CHI-squared test, *DESCRIPTIVE statistics, *LOGISTIC regression analysis, *ODDS ratio, *DISEASE risk factors, *ADULTS, *MIDDLE age
Abstract

Background: Hepatic steatosis is a major cause of chronic liver disease associated with several negative health outcomes. We compared the prevalence of and factors associated with steatosis in people living with and without HIV. Methods: Older (>50 years) and younger (<50 years) people with HIV and older HIV‐negative controls (>50 years) underwent liver transient elastography examination with controlled attenuation parameter (steatosis ≥238 dB/m, moderate/severe steatosis ≥280 dB/m, liver fibrosis ≥7.1 kPa). We compared groups using logistic regression/Chi‐squared/Fisher's exact/Kruskal–Wallis tests. Results: In total, 317 participants (109 older people with HIV; 101 younger people with HIV; 107 HIV‐negative controls) were predominantly white (86%) and male (76%), and 21% were living with obesity (body mass index ≥30 kg/m2). Most (97%) people with HIV had undetectable HIV RNA. The prevalence of fibrosis was 8.4%, 3.0%, and 6.5% in the three groups, respectively (p = 0.26). Fibrosis was predominately (>65%) mild. The prevalence of steatosis was the same in older people with HIV (66.4%) and controls (66.4%) but lower in younger people with HIV (37.4%; p < 0.001). After adjustment, younger people with HIV were less likely to have steatosis (odds ratio [OR] 0.26; 95% confidence interval [CI] 0.14–0.52) than controls, but male sex (OR 2.45; 95% CI 1.20–4.50) and high waist‐to‐hip ratio (OR 3.04; 95% CI 1.74–5.33) were associated with an increased odds of steatosis. We found no association between steatosis and HIV‐related variables. Conclusions: The prevalence of hepatic steatosis and fibrosis was similar between older participants regardless of HIV status. Age, sex, and abdominal obesity, but not HIV‐related variables, were associated with steatosis. Interventions for controlling obesity should be integrated into routine HIV care. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Peripheral Neuropathy in Virologically Suppressed People Living with HIV: Evidence from the PIVOT Trial.

Author

Schuldt, Anna L., Bern, Henry, Hart, Melanie, Gompels, Mark, Winston, Alan, Clarke, Amanda, Chen, Fabian, Stöhr, Wolfgang, Heslegrave, Amanda, Paton, Nicholas I., Petzold, Axel, and Arenas-Pinto, Alejandro

Subjects
PERIPHERAL neuropathy, HIV-positive persons, CD4 lymphocyte count, HIV infections, BLOOD sugar
Abstract

The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20–63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20–1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12–3.16), height (aOR 1.19, 95% CI of 1.05–1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00–1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Trypanosoma cruziscreening in people living with HIV in the UK

Author

Ahmed, Nadia, Herbert, Sophie, Arenas-Pinto, Alejandro, Rickman, Hannah, Benn, Paul, Edwards, Simon G, Chiodini, Peter L, and Grant, Alison D

Abstract

People living with HIV (PLWH) are at higher risk of reactivation of Chagas disease, a neglected tropical disease, caused by Trypanosoma cruzi. There are no data from UK HIV clinics on the prevalence of T. cruzi. We implemented T. cruziscreening at our clinic as part of routine care for PLWH with epidemiological risk factors. Among 86 patients screened, none had positive serology: one seropositive patient was identified due to increased clinician awareness. Implementing T. cruziscreening as part of routine clinical care was feasible, though labour intensive and identified at-risk individuals.

Published
2024
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12. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, Lane, H Clifford, Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, and Wenner, Christine

Abstract

There is a clinical need for therapeutics for COVID-19 patients with acute hypoxemic respiratory failure whose 60-day mortality remains at 30-50%. Aviptadil, a lung-protective neuropeptide, and remdesivir, a nucleotide prodrug of an adenosine analog, were compared with placebo among patients with COVID-19 acute hypoxaemic respiratory failure.

Published
2024
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13. Long-term efficacy and safety of a treatment strategy for HIV infection using protease inhibitor monotherapy: 8-year routine clinical care follow-up from a randomised, controlled, open-label pragmatic trial (PIVOT).

Author

Paton NI, Stöhr W, Arenas-Pinto A, Clarke A, Williams I, Johnson M, Orkin C, Chen F, Lee V, Winston A, Gompels M, Fox J, Sanders K, and Dunn DT

Abstract

Background: Treatment-simplification strategies are important tools for patient-centred management. We evaluated long-term outcomes from a PI monotherapy switch strategy., Methods: Eligible participants attending 43 UK treatment centres had a viral load (VL) below 50 copies/ml for at least 24 weeks on combination ART. Participants were randomised to maintain ongoing triple therapy (OT) or switch to a strategy of physician-selected PI monotherapy (PI-mono) with prompt return to combination therapy if VL rebounded. The primary outcome, previously reported, was loss of future drug options after 3 years, defined as new intermediate/high level resistance to at least one drug to which the participant's virus was considered sensitive at trial entry. Here we report resistance and disease outcomes after further extended follow-up in routine care. The study was registered as ISRCTN04857074., Findings: We randomised 587 participants to OT (291) or PI-mono (296) between Nov 4, 2008, and July 28, 2010 and followed them for a median of more than 8 years (100 months) until 2018. At the end of this follow-up time, one or more future drug options had been lost in 7 participants in the OT group and 6 in the PI-mono group; estimated cumulative risk by 8 years of 2.7% and 2.1% respectively (difference -0.6%, 95% CI -3.2% to 2.0%). Only one PI-mono participant developed resistance to the protease inhibitor they were taking (atazanavir). Serious clinical events (death, serious AIDS, and serious non-AIDS) were infrequent; reported in a total of 12 (4.1%) participants in the OT group and 23 (7.8%) in the PI-mono group (P = 0.08) over the entire follow-up period., Interpretation: A strategy of PI monotherapy, with regular VL monitoring and prompt reintroduction of combination treatment following rebound, preserved future treatment options. Findings confirm the high genetic barrier to resistance of the PI drug class that makes them well suited for creative, patient-centred, treatment-simplification approaches. The possibility of a small excess risk of serious clinical events with the PI monotherapy strategy cannot be excluded., Funding: The National Institute for Health Research Health Technology Assessment programme., Competing Interests: NP reports grants to institution from Janssen; and honoraria for lectures from Janssen. AA-P reports grants to institution from Janssen, ViiV Healthcare and Gilead Sciences and advisory board fees from ViiV Healthcare. AC reports contracts to run clinical trials with payments to institution from Gilead Sciences, ViiV Healthcare, MSD and GSK; honoraria for lectures from MSD; support for attending meetings from ViiV Healthcare and Gilead Sciences; advisory board fees from Gilead Sciences, ViiV Healthcare and Theratechnologies. CO reports grants to institution from Janssen, Gilead, ViiV Healthcare, MSD and Astrazeneca; honoraria for lectures from Janssen, Gilead, ViiV Healthcare and MSD; and unpaid appointments as President of the Medical Women's Federation and a member of the International AIDS Society governing council. MG reports advisory board fees from Gilead. All other authors declare no competing interests., (© 2024 The Author(s).)

Published
2024
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