{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T05:20:04Z","timestamp":1785734404009,"version":"3.56.0"},"reference-count":88,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,7,11]],"date-time":"2024-07-11T00:00:00Z","timestamp":1720656000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"International Treatment Preparedness Coalition","award":["ITPC_MV_2024_1)"],"award-info":[{"award-number":["ITPC_MV_2024_1)"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>More than 80% of people with human immunodeficiency virus (HIV) in low- and middle-income countries (LMICs) take first-line tenofovir-disoproxil\/lamivudine (or emtricitabine)\/dolutegravir (TLD). Due to hard-fought activism, TLD now costs &amp;lt;$45 per person per year in more than 100 LMICs under Voluntary License. With final dolutegravir (DTG) patents expiring by 2029, generic TLD will soon be available globally. Here, we identify seven critical benchmarks that underpin TLDs' success which novel antiretroviral therapy (ART) should now meet, and an eighth benchmark for which novel ART should aim. These benchmarks are superior efficacy; high genetic barrier to resistance; safety in hepatitis B coinfection; favourable drug interaction profiles; HIV2 efficacy; safety in pregnancy, long-acting formulation availability and affordable pricing. We compare the generic TLD availability timeline with development timelines for two case-study novel ART combinations: islatravir\/doravirine and cabotegravir\/rilpivirine. We demonstrate that currently these regimens and trial programs will not meet key benchmarks required to compete with TLD.<\/jats:p>","DOI":"10.1093\/cid\/ciae361","type":"journal-article","created":{"date-parts":[[2024,7,11]],"date-time":"2024-07-11T19:22:19Z","timestamp":1720725739000},"page":"434-443","source":"Crossref","is-referenced-by-count":5,"title":["Challenges for Novel Antiretroviral Development in an Era of Widespread tenofovir-disoproxil\/lamivudine (or emtricitabine)\/dolutegravir availability (TLD) Availability"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5306-6965","authenticated-orcid":false,"given":"Cassandra","family":"Fairhead","sequence":"first","affiliation":[{"name":"The Institute of Tropical Medicine and International Health, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0206-7121","authenticated-orcid":false,"given":"Jacob","family":"Levi","sequence":"additional","affiliation":[{"name":"The Institute of Tropical Medicine and International Health, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6494-7645","authenticated-orcid":false,"given":"Andrew","family":"Hill","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics, University of Liverpool , Liverpool ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,7,11]]},"reference":[{"key":"2025022409323870500_ciae361-B1","author":"Joint United Nations Programme on HIV","year":"2022"},{"key":"2025022409323870500_ciae361-B2","volume-title":"Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines: supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection","author":"World Health Organization","year":"2018"},{"key":"2025022409323870500_ciae361-B3","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1056\/NEJMoa1902824","article-title":"Dolutegravir plus two different prodrugs of tenofovir to treat HIV","volume":"381","author":"Venter","year":"2019","journal-title":"N Engl J Med"},{"key":"2025022409323870500_ciae361-B4","doi-asserted-by":"crossref","first-page":"e677","DOI":"10.1016\/S2352-3018(20)30238-1","article-title":"Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon","volume":"7","author":"Calmy","year":"2020","journal-title":"Lancet HIV"},{"key":"2025022409323870500_ciae361-B5","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1016\/S0140-6736(21)00314-7","article-title":"Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010\/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial","volume":"397","author":"Lockman","year":"2021","journal-title":"Lancet"},{"key":"2025022409323870500_ciae361-B6","volume-title":"HIV market report: the state of the HIV market in low- and middle-income countries. Treatment and market intelligence. 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