A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

References

• Rashid A, Li K, Feng Y, et al. HIV-1 genetic diversity a challenge for AIDS vaccine development: a retrospective bibliometric analysis. Hum Vaccin Immunother. 2022;18(1):2014733. doi:10.1080/21645515.2021.2014733
   PubMed Web of Science ®Google Scholar
• National AIDS Control Organisation & ICMR-National Institute of Medical Statistics. India HIV estimates 2020: technical brief; 2020. Available from: naco.gov.in. Accessed on July 14, 2022.
   Google Scholar
• World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 9789241549684_eng.pdf; 2016. Available from: who.int. Accessed August 17, 2021.
   Google Scholar
• Gupta RK, Gregson J, Parkin N, et al. HIV-1 drug resistance before initiation or re-initiation of first-line antiretroviral therapy in low-income and middle-income countries: a systematic review and meta-regression analysis. Lancet Infect Dis. 2018;18(3):346–355. doi:10.1016/S1473-3099(17)30702-8
   PubMed Web of Science ®Google Scholar
• Bertagnolio S, Hermans L, Jordan MR, et al. Clinical impact of pretreatment human immunodeficiency virus drug resistance in people initiating nonnucleoside reverse transcriptase inhibitor-containing antiretroviral therapy: a systematic review and meta-analysis. J Infect Dis. 2021;224(3):377–388. doi:10.1093/infdis/jiaa683
   PubMed Web of Science ®Google Scholar
• Rutstein SE, Chen JS, Nelson JAE, Phiri S, Miller WC, Hosseinipour MC. High rates of transmitted NNRTI resistance among persons with acute HIV infection in Malawi: implications for first-line dolutegravir scale-up. AIDS Res Ther. 2019;16(1):5. doi:10.1186/s12981-019-0220-8
   PubMed Web of Science ®Google Scholar
• Kantor R, Smeaton L, Vardhanabhuti S, et al. Pretreatment HIV drug resistance and HIV-1 subtype C are independently associated with virologic failure: results from the multinational PEARLS (ACTG A5175) clinical trial. Clin Infect Dis. 2015;60(10):1541–1549. doi:10.1093/cid/civ102
   PubMed Web of Science ®Google Scholar
• Hamers RL, Schuurman R, Sigaloff KC, et al. PharmAccess African Studies to Evaluate Resistance (PASER) Investigators. Effect of pretreatment HIV-1 drug resistance on immunological, virological, and drug-resistance outcomes of first-line antiretroviral treatment in sub-Saharan Africa: a multicentre cohort study. Lancet Infect Dis. 2012;12(4):307–317. doi:10.1016/S1473-3099(11)70255-9
   PubMed Web of Science ®Google Scholar
• World Health Organization. Guidelines on the public health response to pretreatment HIV drug resistance. Geneva: World Health Organization. 9789241550055-eng.pdf; 2017. Available from: who.int. Accessed August 20, 2021.
   Google Scholar
• World Health Organization. Update of recommendations on first- and second-line antiretroviral regimens. Geneva, Switzerland: World Health Organization; 2019. Available from: WHO-CDS-HIV-19.15-eng.pdf. Accessed August 20, 2021.
   Google Scholar
• Kanters S, Vitoria M, Zoratti M, Doherty M, Penazzato M, Rangaraj A. Comparative efficacy, tolerability and safety of dolutegravir and efavirenz 400mg among antiretroviral therapies for first-line HIV treatment: a systematic literature review and network meta-analysis. EClinicalMedicine. 2020;28:2589–5370.
   Google Scholar
• Calmy A, Tovar Sanchez T, Kouanfack C, et al. New antiretroviral and monitoring strategies in HIV-infected adults in low-income countries (NAMSAL) ANRS 12313 Study Group. 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. Lancet HIV. 2020;7(10):e677–e687. doi:10.1016/S2352-3018(20)30238-1
   PubMed Web of Science ®Google Scholar
• Weng YW, Chen IT, Tsai HC, et al. Trend of HIV transmitted drug resistance before and after implementation of HAART regimen restriction in the treatment of HIV-1 infected patients in southern Taiwan. BMC Infect Dis. 2019;23(1):741. doi:10.1186/s12879-019-4389-1
   Web of Science ®Google Scholar
• Cahn P. Candidates for inclusion in a universal antiretroviral regimen: dolutegravir. Curr Opin HIV AIDS. 2017;12(4):318–323. doi:10.1097/COH.0000000000000388
   PubMed Web of Science ®Google Scholar
• Sculier D, Wandeler G, Yerly S, et al. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL’HIV trial. PLoS Med. 2020;10(11):e1003421. doi:10.1371/journal.pmed.1003421
   Web of Science ®Google Scholar
• World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. Geneva: World Health Organization; 2021. Available from: who.int. Accessed August 21, 2021.
   Google Scholar
• Ryom L, Cotter A, De Miguel R, et al. Update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0. HIV Med. 2020;21(10):617–624. doi:10.1111/hiv.12878
   PubMed Web of Science ®Google Scholar
• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services; 2021.
   Google Scholar
• Ahmed N, Angus B, Boffito M, et al. BHIVA guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy. treatment-guidelines-2016-interim-update.pdf; 2015. Available from. bhiva.org. Accessed August 21, 2021.
   Google Scholar
• Nickel K, Halfpenny NJA, Snedecor SJ, Punekar YS. Comparative efficacy, safety and durability of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: an update on a systematic review and network meta-analysis. BMC Infect Dis. 2021;21(1):222. doi:10.1186/s12879-021-05850-0
   PubMed Web of Science ®Google Scholar
• Snedecor SJ, Radford M, Kratochvil D, Grove R, Punekar YS. Comparative efficacy and safety of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: a systematic review and network meta-analysis. BMC Infect Dis. 2019;19(1):484. doi:10.1186/s12879-019-3975-6
   PubMed Web of Science ®Google Scholar
• Kanters S, Vitoria M, Doherty M, et al. Comparative efficacy and safety of first-line antiretroviral therapy for the treatment of HIV infection: a systematic review and network meta-analysis. Lancet HIV. 2016;3(11):e510–e520. doi:10.1016/S2352-3018(16)30091-1
   PubMed Web of Science ®Google Scholar
• National Guidelines for HIV care and treatment. National AIDS control organization. National_Guidelines_for_HIV_Care_and_Treatment_2021.pdf; 2021. Available from. naco.gov.in. Accessed June 15, 2022.
   Google Scholar
• Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383(9936):2222–2231. doi:10.1016/S0140-6736(14)60084-2
   PubMed Web of Science ®Google Scholar
• Walmsley S, Baumgarten A, Berenguer J, et al. Brief report: dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naive patients: week 96 and week 144 results from the SINGLE randomized clinical trial. J Acquir Immune Defic Syndr. 2015;70(5):515–519. doi:10.1097/QAI.0000000000000790
   PubMed Web of Science ®Google Scholar
• Stellbrink HJ, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364–e372. doi:10.1016/S2352-3018(19)30080-3
   PubMed Web of Science ®Google Scholar
• Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381(9868):735–743. doi:10.1016/S0140-6736(12)61853-4
   PubMed Web of Science ®Google Scholar
• Aboud M, Orkin C, Podzamczer D, et al. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019;6(9):e576–e587. doi:10.1016/S2352-3018(19)30149-3
   PubMed Web of Science ®Google Scholar
• Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018;391(10123):839–849. doi:10.1016/S0140-6736(17)33095-7
   PubMed Web of Science ®Google Scholar
• Calza L, Colangeli V, Borderi M, et al. Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. J Antimicrob Chemother. 2020;75(11):3327–3333. doi:10.1093/jac/dkaa319
   PubMed Web of Science ®Google Scholar
• Todd S, Rafferty P, Walker E, et al. Early clinical experience of dolutegravir in an HIV cohort in a larger teaching hospital. Int J STD AIDS. 2017;28(11):1074–1081. doi:10.1177/0956462416688127
   PubMed Web of Science ®Google Scholar
• Wijting I, Rokx C, Boucher C, et al. Dolutegravir as maintenance monotherapy for HIV (DOMONO): a Phase 2, randomised non-inferiority trial. Lancet HIV. 2017;4(12):e547–e554. doi:10.1016/S2352-3018(17)30152-2
   PubMed Web of Science ®Google Scholar
• Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med. 2019;381(9):803–815. doi:10.1056/NEJMoa1902824
   PubMed Web of Science ®Google Scholar
• Namsal ANRS, Kouanfack C, Mpoudi-Etame M, et al. Dolutegravir-based or low-dose efavirenz-based regimen for the treatment of HIV-1. N Engl J Med. 2019;381(9):816–826.
   PubMed Web of Science ®Google Scholar
• Kumarasamy N, Prabhu S, Chandrasekaran E, et al. Safety, tolerability, and efficacy of generic dolutegravir-containing antiretroviral therapy regimens among South Indian human immunodeficiency virus-infected patients. Clin Infect Dis. 2019;68(6):1048–1051. doi:10.1093/cid/ciy763
   PubMed Web of Science ®Google Scholar
• Fernández-Bargiela N, Rotea-Salvo S, Margusino-Framiñán L, et al. Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study. Eur J Hosp Pharm. 2020;29:207–211.
   PubMedGoogle Scholar
• Zheng A, Kumarasamy N, Huang M, Paltiel AD, Mayer KH, Rewari BB. The cost-effectiveness and budgetary impact of a dolutegravir-based regimen as first-line treatment of HIV infection in India. J Int AIDS Soc. 2018;21(3):e25085. doi:10.1002/jia2.25085
   PubMed Web of Science ®Google Scholar
• The Joint United Nations Programme on HIV/AIDS. Ending AIDS: progress Towards the 90-90-90 Targets. Geneva: joint United Nations Programme on HIV/AIDS. Global_AIDS_update_2017_en.pdf; 2017. Available from: unaids.org. Accessed on August 17, 2021.
   Google Scholar
• National AIDS Control Organization (2020). Sankalak: status of National AIDS Response (Second edition, 2020). New Delhi: NACO, Ministry of Health and Family Welfare, Government of India. Sankalak Status of National AIDS Response, Second Edition (2020); 2020. Available from: pdf.naco.gov.in. Accessed August 17, 2021.
   Google Scholar
• National AIDS control organization. National technical guidelines on anti-retroviral treatment; 2018. NACO-National Technical Guidelines on ART_October.2018.1.pdf.
   Google Scholar