Comparative Safety and Changes in Immunologic and Virologic Parameters of Dolutegravir versus Efavirenz-Based Antiretroviral Therapies Among HIV Patients: A Retrospective Cohort Study

References

• Sax PE, Kuritzkes DR. HIV essentials. Jones & Bartlett Learning; 2017. Available from: https://www.amazon.com/HIV-Essentials-2017-Paul-Sax/dp/1284124703. Accessed April 12, 2023.
   Google Scholar
• Lu D, Lu T, Wu H, Che J. Challenges for HIV/AIDS therapy. Adv Pharmacoepidemiol Drug Saf. 2013;2(4):e120.
   Google Scholar
• UNAIDS. Fact sheet - latest global and regional statistics on the status of the AIDS epidemic; 2022.
   Google Scholar
• WHO. HIV fact sheet; 2020. Available from: https://www.who.int/news-room/fact-sheets/detail/hiv-aids. Accessed April 12, 2023.
   Google Scholar
• Pau AK, Clifford Lane H. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Panel on Antiretroviral Guidelines for Adults and Adolescents; 2018.
   Google Scholar
• Jason J, Schafer JMC, Elizabeth M, et al. HIV pharmacotherapy: the pharmacist’s role in care and treatment. In: American Society of Health-System Pharmacists. Elsevier; 2018.
   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
• Federal Ministry of Health. Implementation Manual for DTG Rollout and ART Optimization in Ethiopia. Ethiopia: Federal Ministry of Health; 2019.
   Google Scholar
• Fantauzzi A, Turriziani O, Mezzaroma I. Potential benefit of dolutegravir once daily: efficacy and safety. HIV AIDS. 2013;5:29–40.
   Google Scholar
• Dow DE, Bartlett JA. Dolutegravir, the second-generation of Integrase Strand Transfer Inhibitors (INSTIs) for the treatment of HIV. Infect Dis Ther. 2014;3(2):83–102. doi:10.1007/s40121-014-0029-7
   PubMedGoogle Scholar
• Kandel CE, Walmsley SL. Dolutegravir - a review of the pharmacology, efficacy, and safety in the treatment of HIV. Drug Des Devel Ther. 2015;9:3547–3555. doi:10.2147/DDDT.S84850
   PubMed Web of Science ®Google Scholar
• Vitoria M, Hill A, Ford N, et al. The transition to dolutegravir and other new antiretrovirals in low- and middle-income countries – what are the issues? HIV Global Hepatitis Program. 2018;32(12):1551–1561.
   Google Scholar
• Cruciani M, Malena M. Combination dolutegravir-abacavir-lamivudine in the management of HIV/AIDS: clinical utility and patient considerations. Patient Prefer Adherence. 2015;9:299–310. doi:10.2147/PPA.S65199
   PubMed Web of Science ®Google Scholar
• Walmsley SL, Antela A, Clumeck N, et al. 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. Brief Rep. 2015;70:515–519.
   Google Scholar
• Dehority W, Abadi J, Wiznia A, Viani RM. Use of integrase inhibitors in HIV-infected children and adolescents. Drugs. 2015;75(13):1483–1497. doi:10.1007/s40265-015-0446-2
   PubMed Web of Science ®Google Scholar
• Bruzzese E, Lo Vecchio A, Smarrazzo A. Dolutegravir-based anti-retroviral therapy is effective and safe in HIV-infected paediatric patients. Ital J Pediatr. 2018;44(1):37. doi:10.1186/s13052-018-0469-x
   PubMedGoogle Scholar
• Fourati S, Charpentier C, Amiel C. Cross-resistance to elvitegravir and dolutegravir in 502 patients failing on raltegravir: a French national study of raltegravir-experienced HIV-1-infected patients. J Antimicrob Chemother. 2015;70(5):1507–1512. doi:10.1093/jac/dku535
   PubMed Web of Science ®Google Scholar
• Miller M, Liedtke MD, Rathbun RC, Lockhart SM. The role of dolutegravir in the management of HIV infections. Infect Drug Resist. 2015;19. doi:10.2147/IDR.S58706
   PubMed Web of Science ®Google Scholar
• Saladini F, Giannini A, Boccuto A, et al. Comparable in vitro activities of second-generation HIV-1 integrase strand transfer inhibitors (INSTIs) on HIV-1 clinical isolates with INSTI resistance mutations. Antimicrob Agents Chemother. 2019;64(1):e01717–01719. doi:10.1128/AAC.01717-19
   PubMed Web of Science ®Google Scholar
• Ethiopian Public Health Institute. HIV Related Estimates and Projections in Ethiopia for the Year 2021–2022. Addis Ababa: Ethiopian Public Health Institute; 2022.
   Google Scholar
• UNAIDS/WHO/UNICEF UWaWHCIT. HIV country profile-Ethiopia. In: Global AIDS Monitoring. UNAIDS/WHO/UNICEF UWaWHCIT; 2017.
   Google Scholar
• Cruciani M, Parisi SG, De Socio GV. Dolutegravir based antiretroviral therapy compared to other combined antiretroviral regimens for the treatment of HIV-infected naive patients: a systematic review and meta-analysis. PLoS One. 2019;14(9):e0222229. doi:10.1371/journal.pone.0222229
   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-naive 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
   PubMedGoogle Scholar
• Walmsley SL, Antela A, Clumeck N. Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807–1818. doi:10.1056/NEJMoa1215541
   PubMed Web of Science ®Google Scholar
• Worku ED, Asemahagn MA, Endalifer ML. Epidemiology of HIV infection in the Amhara Region of Ethiopia, 2015 to 2018 surveillance data analysis. HIV AIDS. 2020;12:307–314.
   Google Scholar
• Paul E, Sax CJC, Daniel R. HIV Essentials. 7th ed. Jones & Bartlett Learning; 2014.
   Google Scholar
• Abebe Moges N, Olubukola A, Micheal O, Berhane Y. HIV patients retention and attrition in care and their determinants in Ethiopia: a systematic review and meta-analysis. BMC Infect Dis. 2020;20(1):439. doi:10.1186/s12879-020-05168-3
   PubMed Web of Science ®Google Scholar
• Alemseged Abdissa A, D. Y, Fonager J, et al. Drug resistance in HIV patients with virological failure or slow virological response to antiretroviral therapy in Ethiopia. BMC Infect Dis. 2014;14(1):181. doi:10.1186/1471-2334-14-181
   PubMedGoogle Scholar
• Zash R, Jacobson DL, Diseko M, et al. Comparative safety of dolutegravir-based or efavirenz-based antiretroviral treatment started during pregnancy in Botswana: an observational study. Lancet Global Health. 2018;6(7):e804–e810. doi:10.1016/S2214-109X(18)30218-3
   PubMed Web of Science ®Google Scholar
• Kanters S, Vitoria M, Zoratti M, et al. 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. EClinicalMed. 2020;28:100573. doi:10.1016/j.eclinm.2020.100573
   PubMedGoogle Scholar
• Nickel K, Halfpenny NJ, 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):1–11.
   PubMed Web of Science ®Google Scholar
• Zhong M, Li M, Qi M, et al. A retrospective clinical study of dolutegravir-versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China. Front Immunol. 2023;13:7927. doi:10.1038/s41467-022-35607-5
   Web of Science ®Google Scholar
• Chan P, Yoon B, Colby D, et al. Immunological, cognitive, and psychiatric outcomes after initiating efavirenz-and dolutegravir-based antiretroviral therapy during acute human immunodeficiency virus infection. Clin Infect Dis. 2023;76(3):e718–e726.
   PubMed Web of Science ®Google Scholar
• Bourgi K, Rebeiro PF, Turner M, et al. Greater weight gain in treatment naïve persons starting dolutegravir-based antiretroviral therapy. Clin Infect Dis. 2020;70:1267–1274.
   PubMed Web of Science ®Google Scholar
• Charles Kouanfack MM-E, Bassega PO. 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
• FMoH E. National Consolidated Guidelines for Comprehensive HIV Prevention, Care and Treatment. Federal Ministry of Health; 2018.
   Google Scholar
• Kintu K, Malaba TR, Nakibuka J, et al. Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial. Lancet HIV. 2020;7:e332–e339.
   PubMed Web of Science ®Google Scholar
• Dugdale CM, Ciaranello AL, Bekker LG. Risks and benefits of dolutegravir- and efavirenz-based strategies for South African women with HIV of child-bearing potential: a modeling study. Ann Intern Med. 2019;170(9):614–625. doi:10.7326/M18-3358
   PubMed Web of Science ®Google Scholar
• Phillips AN, Venter F, Havlir D, et al. Risks and benefits of dolutegravir-based antiretroviral drug regimens in sub-Saharan Africa: a modelling study. Lancet HIV. 2019;6(2):e116–127. doi:10.1016/S2352-3018(18)30317-5
   PubMed Web of Science ®Google Scholar
• Hans-Ju¨rgen Stellbrink H-J, Reynes J, Lazzarin A. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS. 2013;27(11):1771–1778. doi:10.1097/QAD.0b013e3283612419
   PubMed Web of Science ®Google Scholar
• Venter WDF, Sokhela S, Simmons B. Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, Phase 3, non-inferiority trial. Lancet HIV. 2020;7(10):e666–e676. doi:10.1016/S2352-3018(20)30241-1
   PubMed Web of Science ®Google Scholar
• Van Lunzen J, Maggiolo F, Arribas JR. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012;12(2):111–118. doi:10.1016/S1473-3099(11)70290-0
   PubMed Web of Science ®Google Scholar
• Allan R, Tenorio BG, Talarico CL, et al. Plasma dolutegravir-based antiretroviral therapy for patients coinfected with tuberculosis and human immunodeficiency virus: a multicenter, noncomparative, open-label, randomized trial. Clin Infect Dis. 2020;70(4):549–556.
   PubMed Web of Science ®Google Scholar
• Gianotti N, Lorenzini P, Cozzi-Lepri A, et al. Durability of different initial regimens in HIV-infected patients starting antiretroviral therapy with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL. J Antimicrob Chemother. 2019;74(9):2732–2741. doi:10.1093/jac/dkz237
   PubMed Web of Science ®Google Scholar
• Brehm TT, Franz M, Hufner A, et al. Safety and efficacy of elvitegravir, dolutegravir, and raltegravir in a real-world cohort of treatment-naive and -experienced patients. Medicine. 2019;98(32):e16721. doi:10.1097/MD.0000000000016721
   PubMed Web of Science ®Google Scholar
• Neesgaard B, Mocroft A, Zangerle R, et al. Virologic and immunologic outcomes of treatment with integrase inhibitors in a real-world setting: the RESPOND cohort consortium. PLoS One. 2020;15(12):e0243625. doi:10.1371/journal.pone.0243625
   PubMed Web of Science ®Google Scholar
• Blanco JR, Alejos B, Moreno S. Impact of dolutegravir and efavirenz on immune recovery markers: results from a randomized clinical trial. Clin Microbiol Infect. 2018;24(8):900–907. doi:10.1016/j.cmi.2017.11.016
   PubMed Web of Science ®Google Scholar
• Abuto W, Abera A, Gobena T, Dingeta T, Markos M. Survival and predictors of mortality among HIV positive adult patients on highly active antiretroviral therapy in public hospitals of Kambata Tambaro Zone, Southern Ethiopia: a retrospective cohort study. HIV AIDS. 2021;13:271–281.
   Google Scholar
• Siedner MJ, Moorhouse MA, Simmons B, et al. Reduced efficacy of HIV-1 integrase inhibitors in patients with drug resistance mutations in reverse transcriptase. Nat Commun. 2020;11(1). doi:10.1038/s41467-020-19801-x
   PubMed Web of Science ®Google Scholar
• Mehtani NJ, Puryear S, Pham P, Dooley KE, Shah M. Infectious diseases learning unit: understanding advances in the treatment of latent tuberculosis infection among people with human immunodeficiency virus. Open Forum Infect Dis. 2021;8(8):ofab319. doi:10.1093/ofid/ofab319
   PubMed Web of Science ®Google Scholar
• Wiznia AAC, Fenton T. Dolutegravir in 6--12 year old HIV infected children: 48--week results from IMPAACT P1093. Pediatr Infect Dis J. 2015;34(11):1207.
   PubMed Web of Science ®Google Scholar
• Mondi A, Cozzi-Lepri A, Tavelli A, et al. Effectiveness of dolutegravir-based regimens as either first-line or switch antiretroviral therapy: data from the Icona cohort. J Int AIDS Soc. 2019;22(1):e25227. doi:10.1002/jia2.25227
   PubMed Web of Science ®Google Scholar
• Benoît Trottier JEL, Lake JE, Logue K, et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, phase IIIb study. Antivir Ther. 2017;22(4):295–305. doi:10.3851/IMP3166
   PubMed Web of Science ®Google Scholar
• Gebremeskel TG, Gebreyowhans D, Abrha Gesesew H, Ward PR. Incidence and predictors of severe adverse drug reaction among patients on antiretroviral therapy in Tigray, Ethiopia: a retrospective cohort study. HIV AIDS. 2021;13:641–649. doi:10.2147/HIV.S310419
   Google Scholar
• Taramasso L, Bonfanti P, Ricci E, et al. Factors associated with weight gain in people treated with dolutegravir. Open Forum Infect Dis. 2020;7(6):ofaa195. doi:10.1093/ofid/ofaa195
   PubMed Web of Science ®Google Scholar
• Alemnew M. Comparative Safety and Survival Rate of Dolutegravir with Efavirenz Based Antiretroviral Therapies for First-Line HIV Treatment Among Patients in Amhara Region, Ethiopia: Retrospective Cohort Study. AAU Institutional Repository; 2022.
   Google Scholar