{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T18:07:43Z","timestamp":1789150063647,"version":"build-2803163510"},"reference-count":44,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T00:00:00Z","timestamp":1706745600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In British Columbia, antiretrovirals (ARVs) for HIV treatment (HIV-Tx) and pre-exposure prophylaxis (PrEP) are free-of-charge through publicly-funded Drug Treatment Programs (DTPs). When available, less costly generics are substituted for brand-name ARVs. We describe the incidence and type of product substitution issue (PSI) adverse drug reactions (ADRs) attributed to generic ARVs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Cohorts included DTP clients \u226519\u00a0years who received generic ARVs for HIV-Tx (abacavir-lamivudine, emtricitabine-tenofovir DF, efavirenz-emtricitabine-tenofovir DF, atazanavir or darunavir between 01 Jun 2017 and 30 Jun 2022) or PrEP (emtricitabine-tenofovir DF, 01 Apr 2018 to 30 Jun 2022). Demographic, ARV and ADR data were extracted from DTP databases and summarized by descriptive statistics. PSI incidence was calculated for each product during the year following brand-to-generic and generic-to-generic transitions (first-year-post-rollout), and compared between generic versions using generalized estimating equations. For context, incidence of any ARV product-related ADR was calculated in the same 1-year periods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>During first-year-post-rollout periods, 5339 HIV-Tx (83% male, median age 52\u00a0years) and 8095 PrEP (99% male, median 33\u00a0years) clients received generic ARVs, and reported 78 and 23 generic PSIs, respectively. PSI incidence was &lt;1% for most generic ARVs, with mild-moderate symptoms including gastrointestinal upset, headache, dizziness, fatigue\/malaise and skin rash. In HIV-Tx clients, the efavirenz-containing product had higher PSI incidence than other ARVs (2.2%, p = .004), due to more neuropsychiatric adverse reactions. Any ADR incidence was stable across measurement periods, and generic PSIs represented less than one third of all product-related ADRs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Generic substitution of antiretrovirals for HIV-Tx and PrEP was well tolerated, with \u22642% incidence of mild-moderate PSI ADRs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535241233128","type":"journal-article","created":{"date-parts":[[2024,2,20]],"date-time":"2024-02-20T03:54:22Z","timestamp":1708401262000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Adverse drug reactions attributed to generic substitution of antiretroviral medications among HIV treatment and pre-exposure prophylaxis clients in British Columbia, Canada"],"prefix":"10.1177","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8358-8529","authenticated-orcid":false,"given":"Katherine J","family":"Lepik","sequence":"first","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"},{"name":"Pharmacy Department, Saint Paul\u2019s Hospital, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia L","family":"Hunt","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nic","family":"Bacani","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Wang","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Harris","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"},{"name":"Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junine","family":"Toy","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"},{"name":"Pharmacy Department, Saint Paul\u2019s Hospital, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor","family":"McLinden","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Sereda","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda J","family":"Akagi","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Saint Paul\u2019s Hospital, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Ready","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Saint Paul\u2019s Hospital, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio SG","family":"Montaner","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"},{"name":"Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolando","family":"Barrios","sequence":"additional","affiliation":[{"name":"BC Centre for Excellence in HIV\/AIDS, Vancouver, BC, Canada"},{"name":"School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,2,20]]},"reference":[{"key":"bibr1-13596535241233128","volume-title":"The Safety and Effectiveness of Generic Drugs","author":"Health Canada Government of Canada","year":"2012"},{"key":"bibr2-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1016\/j.healthpol.2018.01.002"},{"key":"bibr3-13596535241233128","first-page":"S5","volume":"19","author":"Waters L","year":"2018","journal-title":"HIV Med"},{"key":"bibr4-13596535241233128","volume-title":"Drug Treatment Program- HIV Treatment","author":"BC Centre for Excellence in HIV\/AIDS","year":"2023"},{"key":"bibr5-13596535241233128","volume-title":"HIV Pre Exposure Prophylaxis Program (PrEP)","author":"BC Centre for Excellence in HIV\/AIDS","year":"2023"},{"key":"bibr6-13596535241233128","volume-title":"BC PharmaCare Low Cost Alternative (LCA) Program","author":"Ministry of Health Province of British Columbia","year":"2023"},{"key":"bibr7-13596535241233128","unstructured":"Montessori V, Montaner JSG. Generic Antiretroviral Products Available on BC-CfE Formulary (Notice to Prescribers). Vancouver, BC: BC Centre for Excellence in HIV\/AIDS. Available at: https:\/\/www.bccfe.ca\/sites\/default\/files\/uploads\/dear-doctor-letters\/dear_prescriber_generic_antiretroviral_products_5_july_2018.pdf 2018. (Accessed 01 August 2023)."},{"key":"bibr8-13596535241233128","volume-title":"HIV Drugs Available Through the BC-CfE","author":"BC Centre for Excellence in HIV\/AIDS","year":"2023"},{"issue":"4","key":"bibr9-13596535241233128","first-page":"16","volume":"21","author":"Lepik K","year":"2019","journal-title":"Positive Living Society of BC"},{"key":"bibr10-13596535241233128","volume-title":"Therapeutic Guidelines for Antiretroviral (ARV) Treatment of Adult HIV Infection","author":"BC Centre for Excellence in HIV\/AIDS","year":"2023"},{"key":"bibr11-13596535241233128","volume-title":"HIV Drug Safety (the BC-CfE Pharmacovigilance Initiative)","author":"BC Centre for Excellence in HIV\/AIDS","year":"2022"},{"key":"bibr12-13596535241233128","unstructured":"Product substitution issue (definition); in Medical Dictionary for Regulatory Activities Terminology (MedDRA\u00ae), Accessed via BioPortal, Stanford CA: National Centre for Biomedical Ontology. Available at: http:\/\/purl.bioontology.org\/ontology\/MEDDRA\/10069326 2023. (accessed 02 August 2023)."},{"key":"bibr13-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyu046"},{"key":"bibr14-13596535241233128","unstructured":"Harrison J. Biological Product Concepts in MedDRA; DIA Clinical Safety and Pharmacovigilance Community, Community Call. Fort Washington, PA: DIA Americas. Available at: https:\/\/admin.meddra.org\/sites\/default\/files\/page\/documents_insert\/dia_csp_community_call_guest_presentation_msso_20apr2017.pdf 2017. (Accessed 01 January 2022)."},{"key":"bibr15-13596535241233128","unstructured":"MedDRA\u00ae term selection: Points to consider. ICH-Endorsed Guide for MedDRA Users. Release 4.11 based on MedRA version 19.0. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Available at: https:\/\/mssotools.com\/mssoweb\/PTC\/ts_ptc_r411.html (Accessed 01-Jan 2022)."},{"key":"bibr16-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1016\/j.addbeh.2006.03.030"},{"key":"bibr17-13596535241233128","volume-title":"Kivexa (Abacavir and Lamivudine) Tablets, Product Monograph","year":"2023"},{"key":"bibr18-13596535241233128","volume-title":"Truvada (Emtricitabine\/Tenofovir Disoproxil Fumarate) Tablets, Product Monograph","year":"2018"},{"key":"bibr19-13596535241233128","volume-title":"Atripla (Efavirenz\/Emtricitabine\/Tenofovir Disoproxil Fumarate) Tablets, Product Monograph","year":"2020"},{"key":"bibr20-13596535241233128","volume-title":"Reyataz (Atazanavir) Capsules, Product Monograph","year":"2020"},{"key":"bibr21-13596535241233128","volume-title":"Prezista (Darunavir) Tablets, Product Monograph","year":"2023"},{"key":"bibr22-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2017.06.009"},{"key":"bibr23-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-016-1871-x"},{"key":"bibr24-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy763"},{"key":"bibr25-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1080\/09540121.2012.748160"},{"key":"bibr26-13596535241233128","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-2-201301150-00002"},{"key":"bibr27-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1710914"},{"key":"bibr28-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0117214"},{"key":"bibr29-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1177\/0956462417696215"},{"key":"bibr30-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkz439"},{"key":"bibr31-13596535241233128","doi-asserted-by":"publisher","DOI":"10.3851\/IMP3321"},{"key":"bibr32-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0239704"},{"key":"bibr33-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12701"},{"key":"bibr34-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-018-0252-z"},{"key":"bibr35-13596535241233128","doi-asserted-by":"publisher","DOI":"10.2515\/therapie\/2014036"},{"key":"bibr36-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000876"},{"key":"bibr37-13596535241233128","doi-asserted-by":"publisher","DOI":"10.2174\/1574886311207040309"},{"key":"bibr38-13596535241233128","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2009.30.3199"},{"key":"bibr39-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1111\/cod.13787"},{"key":"bibr40-13596535241233128","volume-title":"The Use of the WHO-UMC System for Standardised Case Causality Assessment","author":"Uppsala Monitoring Centre","year":"2018"},{"key":"bibr41-13596535241233128","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629050-00003"},{"key":"bibr42-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1037\/hea0000282"},{"key":"bibr43-13596535241233128","first-page":"451","volume":"65","author":"Weissenfeld J","year":"2010","journal-title":"Pharmazie"},{"key":"bibr44-13596535241233128","doi-asserted-by":"publisher","DOI":"10.1186\/s40780-020-00180-w"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535241233128","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13596535241233128","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535241233128","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:53:14Z","timestamp":1777380794000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/13596535241233128"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2]]},"references-count":44,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1177\/13596535241233128"],"URL":"https:\/\/doi.org\/10.1177\/13596535241233128","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2]]},"article-number":"13596535241233128"}}