ARV Treatment, References

References Part II - ARV Treatment

Cohen MS, Chen YQ, McAuley M et al. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med 2016; 375:830-839. DOI:10.1056/ NEJMoa1600693

Insight Start study group: Lundgren JD, Babiker AG, Gordin F et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015 Aug 27; 373(9):795-807 DOI:10.1056/NEJMoa1506816

Landovitz RJ, Donnell D, Clement ME, et al. HPTN 083 Study Team. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women.N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016. PMID: 34379922
First study to demonstrate the effectiveness of cabotegravir in MSM and TGW

Lockman S, Brummel SS, Ziemba L, et al. 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 2. Lancet. 2021;397(10281):1276-1292. doi:10.1016/S0140-6736(21)00314-7
Randomized trial including HIV-1 pregnant women at 14–28 weeks’ gestation, comparing TAF/FTC + DTF vs. TDF/FTC + DTG vs. TDF/FTC/EFV. At delivery, DTG regimens were superior to TDF/FTC/EFV in virological efficacy. TAF/FTC + DTG had the lowest frequency of composite adverse pregnancy outcomes and of neonatal deaths

Luetkemeyer AF, Donnell D, Dombrowski JC, et al. DoxyPEP Study Team. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections N Engl J Med. 2023 Apr 6;388(14):1296-1306. doi: 10.1056/ NEJMoa2211934. PMID: 37018493
Study among MSM on PrEP or living with HIV showing the reduction of STI incidence with doxycycline PEP

Molina JM, Squires K, Sax PE, et al for the DRIVE-FORWARD trial group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial. Lancet HIV. 2020;7: e16–e26. doi:10.1016/S2352-3018(19)30336-4
Randomized trial where DOR + 2NRTIs was non-inferior compared to DRV/r + NRTIs in HIV-1 ART-naïve participants at 96 weeks

Molina JM, Ghosn J, Assoumou L, et al. ANRS PREVENIR Study Group. Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Lancet HIV. 2022 Aug;9(8):e554-e562. doi: 10.1016/S2352- 3018(22)00133-3. Epub 2022 Jun 27. PMID: 35772417
Large cohort of MSM using oral TDF/FTC for PrEP either daily or on demand with a very low and similar HIV incidence

Orkin C, Squires KE, Molina JM, et al for the DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/ Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial. Clin Infect Dis. 2021;73: 33–42. doi:10.1093/cid/ciaa822
Randomized trial where TDF/3TC/DOR was non-inferior compared to TDF/ FTC/EFV in HIV-1 ART-naïve participants at 96 weeks

Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection: 152-week results from ATLAS-2M, a randomized, open-label, Phase 3b, non-inferiority study Clin Infect Dis. 2023 May 3;76(9):1646-1654. doi: 10.1093/cid/ciad020
Long-term follow up of long acting CAB/RPV, confirms the long-term efficacy, safety, and tolerability of CAB+RPV LA every two months to maintain viral suppression

Paton NI, Musaazi J, Kityo C, et al. Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial. Lancet HIV. 2022; S2352301822000923. doi:10.1016/S2352- 3018(22)00092-3
Randomized trial where switching to DTG based regimen is non inferior to DRV based regimen 96 weeks after first line treatment failure but is a greater risk of resistance. Tenofovir should be continued rather than being switched to zidovudine

Patel K, Huo Y, Jao J, et al. Pediatric HIV/AIDS Cohort Study; Swiss Mother and Child HIV Cohort Study. Dolutegravir in Pregnancy as Compared with Current HIV Regimens in the United States. N Engl J Med. 2022 Sep 1;387(9):799-809. doi: 10.1056/NEJMoa2200600. PMID: 36053505
No clear differences in adverse birth outcomes with dolutegravir-based ART as compared with non-dolutegravir-based ART, although samples were small

Segal-Maurer S, DeJesus E, Stellbrink HJ et al. CAPELLA Study Investigators. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022 May 12;386(19):1793-1803. doi: 10.1056/ NEJMoa2115542. PMID: 35544387
First study to demonstrate the antiviral activity of lenacapavir in patients with multiresistant HIV-1

World Health Organization-WHO. Hiv Prevention, Infant Diagnosis, Antiretroviral Initiation and Monitoring Guidelines; 2021
Last WHO guidance including updated recommendation to initiate ART as soon as possible after initiating TB treatment when there is TB-HIV co-infection, irrespective of CD4 count (except if signs/symptoms of TB meningitis are present)