Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial

Detalhes bibliográficos
Autor(a) principal: Avihingsanon, Anchalee
Data de Publicação: 2022
Outros Autores: Hughes, Michael D., Salata, Robert, Godfrey, Catherine, McCarthy, Caitlyn, Mugyenyi, Peter, Hogg, Evelyn, Gross, Robert, Cardoso, Sandra W., Bukuru, Aggrey, Makanga, Mumbi, Badal-Aesen, Sharlaa, Mave, Vidya, Ndege, Beatrice Wangari, Fontain, Sandy Nerette, Samaneka, Wadzanai, Secours, Rode, Schalkwyk, Marije Van, Mngqibisa, Rosie, Mohapi, Lerato, Valencia, Javier, Sugandhavesa, Patcharaphan, Montalban, Esmelda, Munyanga, Cornelius, Chagomerana, Maganizo, Santos, Breno R., Kumarasamy, Nagalingeswaran, Kanyama, Cecilia, Schooley, Robert T., Mellors, John W., Wallis, Carole L., Collier, Ann C., Grinsztejn, Beatriz
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/55522
Resumo: Chulalongkorn University. Faculty of Medicine. Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis. HIV-NAT. Bangkok, Thailand.
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spelling Avihingsanon, AnchaleeHughes, Michael D.Salata, RobertGodfrey, CatherineMcCarthy, CaitlynMugyenyi, PeterHogg, EvelynGross, RobertCardoso, Sandra W.Bukuru, AggreyMakanga, MumbiBadal-Aesen, SharlaaMave, VidyaNdege, Beatrice WangariFontain, Sandy NeretteSamaneka, WadzanaiSecours, RodeSchalkwyk, Marije VanMngqibisa, RosieMohapi, LeratoValencia, JavierSugandhavesa, PatcharaphanMontalban, EsmeldaMunyanga, CorneliusChagomerana, MaganizoSantos, Breno R.Kumarasamy, NagalingeswaranKanyama, CeciliaSchooley, Robert T.Mellors, John W.Wallis, Carole L.Collier, Ann C.Grinsztejn, Beatriz2022-11-07T19:41:35Z2022-11-07T19:41:35Z2022AVIHINGSANON, Anchalee et al. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. Journal of the International AIDS Society, v. 25, n. 6, p. 1-6, 20221758-2652https://www.arca.fiocruz.br/handle/icict/5552210.1002/jia2.25905engWileyThird-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleChulalongkorn University. Faculty of Medicine. Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis. HIV-NAT. Bangkok, Thailand.Harvard T H Chan School of Public Health. Center for Biostatistics in AIDS Research in the Department of Biostatistics. Boston, Massachusetts, USA.Case Western Reserve University. Cleveland, Ohio, USA.National Institutes of Health. National Institutes of Allergy and Infectious Disease. Division of AIDS. Bethesda, Maryland, USA.Harvard T H Chan School of Public Health. Center for Biostatistics in AIDS Research in the Department of Biostatistics. Boston, Massachusetts, USA.Joint Clinical Research Center. Kampala, Uganda.Social & Scientific Systems, Inc., a DLH Holdings Company. Silver Spring, Maryland, USA.University of Pennsylvania. Center for Clinical Epidemiology and Biostatistics. Philadelphia, Pennsylvania, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.Joint Clinical Research Center. Kampala, Uganda.Kenya Medical Research Institute. Center of Disease Control. Kisumu, Kenya.University of Witwatersrand. Helen Joseph Hospital. Clinical HIV Research Unit. Johannesburg, South Africa.BJ Medical College Clinical Research Site. Pune, India.Moi University Clinical Research Center (MUCRC) CRS. Eldoret, Kenya.Les Centres GHESKIO Clinical Research Site. Port-au-Prince, Haiti.University of Zimbabwe Clinical Trials Research Centre. Harare, Zimbabwe.Les Centres GHESKIO Clinical Research Site. Port-au-Prince, Haiti.Stellenbosch University. Family Centre for Research with Ubuntu (FAMCRU). Cape Town, South Africa.Enhancing Care Foundation. King Edward Hospital. Durban International Clinical Research Site. Durban, South Africa.University of the Witwatersrand. Perinatal HIV Research Unit. Clinical Research Site. Soweto AIDS Clinical Trials Group. Johannesburg, South Africa.Barranco Clinical Research Site. Lima, Peru.Chiang Mai University. Research Institute for Health Sciences. Chiang Mai, Thailand.San Miguel Clinical Research Site. Lima, Peru.University of North Carolina Project. Kamazu Central Hospital. Lilongwe, Malawi.University of North Carolina Project. Kamazu Central Hospital. Lilongwe, Malawi.Hospital Nossa Senhora da Conceicao CRS. Porto Alegre, RS, Brazil.VHS Infection Disease Medical Centre. Clinical Research Site. CART. Chennai, India.University of North Carolina Project. Kamazu Central Hospital. Lilongwe, Malawi.University of California. Division of Infectious Diseases. San Diego, California, USA.University of Pittsburgh School of Medicine. Department of Medicine. Division of Infectious Diseases. Pittsburgh, Pennsylvania, USA.BARC-South Africa and Lancet Laboratories. Johannesburg, South Africa.University of Washington. School of Medicine. Seattle, Washington, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.Introduction: ACTG A5288 was a strategy trial conducted in diverse populations from multiple continents of people living with HIV (PLWH) failing second-line protease inhibitor (PI)-based antiretroviral therapy (ART) from 10 low- and middle-income countries (LMICs). Participants resistant to lopinavir (LPV) and/or multiple nucleotide reverse transcriptase inhibitors started on third-line regimens that included raltegravir (RAL), darunavir/ritonavir (DRV/r) and/or etravirine (ETR) according to their resistance profiles. At 48 weeks, 87% of these participants achieved HIV-1 RNA ≤200 copies/ml. We report here long-term outcomes over 144 weeks. Methods: Study participants were enrolled from 2013 to 2015, prior to the availability of dolutegravir in LMICs. "Extended Follow-up" of the study started after the last participant enrolled had reached 48 weeks and included participants still on antiretroviral (ARV) regimens containing RAL, DRV/r and/or ETR at that time. RAL, DRV/r and ETR were provided for an additional 96 weeks (giving total follow-up of ≥144 weeks), with HIV-1 RNA measured at 48 and 96 weeks and CD4 count at 96 weeks after entry into Extended Follow-up. Proportion of participants with HIV-1 RNA ≤200 copies/ml was estimated every 24 weeks, using imputation if necessary to handle the different measurement schedule in Extended Follow-up; mean CD4 count changes were estimated using loess regression. Results and discussion: Of 257 participants (38% females), at study entry, median CD4 count was 179 cells/mm3 , and HIV-1 RNA was 4.6 log10 copies/ml. Median follow-up was 168 weeks (IQR: 156-204); 15 (6%) participants were lost to follow-up and 9 (4%) died. 27/246 (11%), 26/246 (11%) and 13/92 (14%) of participants who started RAL, DRV/r and ETR, respectively, discontinued these drugs; only three due to adverse events. 87%, 86%, 83% and 80% of the participants had HIV-1 RNA ≤200 copies/ml at weeks 48, 96, 144 and 168 (95% CI at week 168: 74-85%), respectively. Mean increase from study entry in CD4 count at week 168 was 265 cells/mm3 (95% CI 247-283). Conclusions: Third-line regimens comprising of RAL, DRV/r and/or ETR were very well tolerated and had high rates of durable virologic suppression among PLWH in LMICs who were failing on second-line PI-based ART prior to the availability of dolutegravir.144 weeks efficacyA5288LMICDarunavirDrug resistanceThird-line ARTinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALThird‐line_Beatriz_Grinsztejn_etal_INI_2022.pdfThird‐line_Beatriz_Grinsztejn_etal_INI_2022.pdfapplication/pdf452923https://www.arca.fiocruz.br/bitstream/icict/55522/2/Third%e2%80%90line_Beatriz_Grinsztejn_etal_INI_2022.pdf4ce20acf9d1ea0ab502859f7ea97719cMD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/55522/1/license.txt5a560609d32a3863062d77ff32785d58MD51icict/555222022-11-07 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dc.title.en_US.fl_str_mv Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
title Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
spellingShingle Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
Avihingsanon, Anchalee
144 weeks efficacy
A5288
LMIC
Darunavir
Drug resistance
Third-line ART
title_short Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
title_full Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
title_fullStr Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
title_full_unstemmed Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
title_sort Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial
author Avihingsanon, Anchalee
author_facet Avihingsanon, Anchalee
Hughes, Michael D.
Salata, Robert
Godfrey, Catherine
McCarthy, Caitlyn
Mugyenyi, Peter
Hogg, Evelyn
Gross, Robert
Cardoso, Sandra W.
Bukuru, Aggrey
Makanga, Mumbi
Badal-Aesen, Sharlaa
Mave, Vidya
Ndege, Beatrice Wangari
Fontain, Sandy Nerette
Samaneka, Wadzanai
Secours, Rode
Schalkwyk, Marije Van
Mngqibisa, Rosie
Mohapi, Lerato
Valencia, Javier
Sugandhavesa, Patcharaphan
Montalban, Esmelda
Munyanga, Cornelius
Chagomerana, Maganizo
Santos, Breno R.
Kumarasamy, Nagalingeswaran
Kanyama, Cecilia
Schooley, Robert T.
Mellors, John W.
Wallis, Carole L.
Collier, Ann C.
Grinsztejn, Beatriz
author_role author
author2 Hughes, Michael D.
Salata, Robert
Godfrey, Catherine
McCarthy, Caitlyn
Mugyenyi, Peter
Hogg, Evelyn
Gross, Robert
Cardoso, Sandra W.
Bukuru, Aggrey
Makanga, Mumbi
Badal-Aesen, Sharlaa
Mave, Vidya
Ndege, Beatrice Wangari
Fontain, Sandy Nerette
Samaneka, Wadzanai
Secours, Rode
Schalkwyk, Marije Van
Mngqibisa, Rosie
Mohapi, Lerato
Valencia, Javier
Sugandhavesa, Patcharaphan
Montalban, Esmelda
Munyanga, Cornelius
Chagomerana, Maganizo
Santos, Breno R.
Kumarasamy, Nagalingeswaran
Kanyama, Cecilia
Schooley, Robert T.
Mellors, John W.
Wallis, Carole L.
Collier, Ann C.
Grinsztejn, Beatriz
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Avihingsanon, Anchalee
Hughes, Michael D.
Salata, Robert
Godfrey, Catherine
McCarthy, Caitlyn
Mugyenyi, Peter
Hogg, Evelyn
Gross, Robert
Cardoso, Sandra W.
Bukuru, Aggrey
Makanga, Mumbi
Badal-Aesen, Sharlaa
Mave, Vidya
Ndege, Beatrice Wangari
Fontain, Sandy Nerette
Samaneka, Wadzanai
Secours, Rode
Schalkwyk, Marije Van
Mngqibisa, Rosie
Mohapi, Lerato
Valencia, Javier
Sugandhavesa, Patcharaphan
Montalban, Esmelda
Munyanga, Cornelius
Chagomerana, Maganizo
Santos, Breno R.
Kumarasamy, Nagalingeswaran
Kanyama, Cecilia
Schooley, Robert T.
Mellors, John W.
Wallis, Carole L.
Collier, Ann C.
Grinsztejn, Beatriz
dc.subject.en.en_US.fl_str_mv 144 weeks efficacy
A5288
LMIC
Darunavir
Drug resistance
Third-line ART
topic 144 weeks efficacy
A5288
LMIC
Darunavir
Drug resistance
Third-line ART
description Chulalongkorn University. Faculty of Medicine. Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis. HIV-NAT. Bangkok, Thailand.
publishDate 2022
dc.date.accessioned.fl_str_mv 2022-11-07T19:41:35Z
dc.date.available.fl_str_mv 2022-11-07T19:41:35Z
dc.date.issued.fl_str_mv 2022
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv AVIHINGSANON, Anchalee et al. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. Journal of the International AIDS Society, v. 25, n. 6, p. 1-6, 2022
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/55522
dc.identifier.issn.en_US.fl_str_mv 1758-2652
dc.identifier.doi.none.fl_str_mv 10.1002/jia2.25905
identifier_str_mv AVIHINGSANON, Anchalee et al. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. Journal of the International AIDS Society, v. 25, n. 6, p. 1-6, 2022
1758-2652
10.1002/jia2.25905
url https://www.arca.fiocruz.br/handle/icict/55522
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/55522/2/Third%e2%80%90line_Beatriz_Grinsztejn_etal_INI_2022.pdf
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MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1798324825861652480