{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:12:50Z","timestamp":1747185170557,"version":"3.40.5"},"reference-count":47,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,7,20]],"date-time":"2020-07-20T00:00:00Z","timestamp":1595203200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>As per National AIDS Control Organization (NACO) estimates, there are 2.1 million people living with HIV (PWH) in India, of whom 1.2 million are on first\u2010line antiretroviral therapy (ART). This study explored the use of a single\u2010tablet regimen containing tenofovir disoproxil fumarate 300\u00a0mg + lamivudine 300\u00a0mg + efavirenz 400\u00a0mg (TLE400 STR) as a first\u2010line switch strategy in PWH in Pune, India.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This retrospective cohort study was conducted in private sector ART clinics in three tertiary\u2010level hospitals in Pune, India. PWH &gt; 12\u00a0years of age (<jats:italic>n<\/jats:italic>\u00a0=\u00a0502) who initiated first\u2010line ART (predominantly TLE600 STR), completed \u2265 6 months of follow\u2010up and achieved virological suppression [plasma viral load (VL) &lt; 1000 HIV\u20101 RNA copies\/mL] were identified and switched to TLE400 STR. The virological and immunological efficacy of TLE400 STR at 6 and 12\u00a0months of follow\u2010up were noted. Grade 3\/4 adverse events (especially efavirenz\u2010related neuropsychiatric adverse events) leading to regimen discontinuation were also noted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 502 PWH who switched to TLE400 STR, complete virological suppression (VL\u00a0&lt;\u00a020 copies\/mL) was maintained in more than 97% of patients at follow\u2010up. TLE400 STR was successful in maintaining CD4 counts within the range observed at the start of the regimen. Grade 3\/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2.2%) patients. Virological failure (VL &gt; 1000 copies\/mL) and treatment regimen failure were seen in six (1.2%) and 49 (9.8%) subjects, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>TLE400 STR exhibits excellent efficacy and safety as a switch strategy and should be introduced in the Indian National ART Program, especially for PWH who are virologically suppressed on TLE600 STR.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12912","type":"journal-article","created":{"date-parts":[[2020,7,21]],"date-time":"2020-07-21T02:24:46Z","timestamp":1595298286000},"page":"578-587","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of a single\u2010tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV\u20101\u2010infected subjects on nonnucleoside reverse transcriptase inhibitor\u2010containing first\u2010line antiretroviral therapy in Pune, India"],"prefix":"10.1111","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1909-7530","authenticated-orcid":false,"given":"A","family":"Dravid","sequence":"first","affiliation":[{"name":"Department of Medicine Ruby Hall Clinic Pune Maharashtra India"},{"name":"Department of Medicine Poona Hospital and Research Centre Pune Maharashtra India"},{"name":"Department of Medicine Noble Hospital Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"TP","family":"Betha","sequence":"additional","affiliation":[{"name":"Department of Medicine Poona Hospital and Research Centre Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"AK","family":"Sharma","sequence":"additional","affiliation":[{"name":"Department of Medicine Poona Hospital and Research Centre Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R","family":"Gawali","sequence":"additional","affiliation":[{"name":"Department of Medicine Poona Hospital and Research Centre Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"U","family":"Mahajan","sequence":"additional","affiliation":[{"name":"Department of Biostatistics VMK Diagnostics Private Limited Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Kulkarni","sequence":"additional","affiliation":[{"name":"Department of Medicine Ruby Hall Clinic Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Saraf","sequence":"additional","affiliation":[{"name":"Department of Pathology VMK Diagnostics Private Limited Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S","family":"Kore","sequence":"additional","affiliation":[{"name":"Department of Dermatology Ashwini Sahakari Rugnalaya and Research Centre Solapur Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Dravid","sequence":"additional","affiliation":[{"name":"Infectious Disease Clinic Dhule Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N","family":"Rathod","sequence":"additional","affiliation":[{"name":"Department of Medicine Apex Hospital Kolhapur Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,7,20]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_8_2_1","DOI":"10.1097\/QAD.0000000000002321"},{"unstructured":"WHO | Data and statistics. 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