ARV Treatment of PLWH, References

References Part II - ARV Treatment of PLWH

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 Jan;7(1):e16-e26. doi: 10.1016/S2352-3018(19)30336-4. Epub 2019 Nov 15.PMID: 31740348
Randomized trial where DOR + 2NRTIs was non-inferior compared to DRV/r + NRTIs in HIV-1 ART-naïve participants at 96 weeks

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. 2020 Dec 18:ciaa822. doi: 10.1093/cid/ciaa822. Online ahead of print. PMID: 33336698
Randomized trial where TDF/3TC/DOR was non-inferior compared to TDF/ FTC/EFV in HIV-1 ART-naïve participants at 96 weeks

Rizzardini G, Overton ET, Orkin C, et al. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506. doi: 10.1097/QAI.0000000000002466.PMID: 33136751
Combined analysis from ATLAS and FLAIR randomized trials showing non-inferiority at 48 weeks of long-acting monthly CAB + RPV injections compared to current antiretroviral daily oral regimen in virologically suppressed participants

Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/ S0140-6736(20)32666-0. Epub 2020 Dec 9.
Randomized trial where CAB + RPV long-acting im injections every 8 weeks was non-inferior to dosing every 4 weeks for maintenance of virological suppression

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

World Health Organization-WHO. Hiv Prevention, Infant Diagnosis, Antiretroviral Initiation and Monitoring Guidelines.; 2021.
New 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)

De Castro N, Marcy O, Chazallon C, et al for the ANRS 12300 Reflate TB2 study group. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial. Lancet Infect Dis. 2021 Mar 2:S1473-3099(20)30869-0. doi: 10.1016/S1473- 3099(20)30869-0. Online ahead of print.
Randomized trial including ART naïve HIV-participants receiving rifampicin-containing tuberculosis treatment. At 48 weeks, RAL 400 mg bid did not meet non-inferiority criteria for virological suppression compared to EFV 600 mg daily, both in combination with TDF + 3TC

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

The TEMPRANO ANRS 12136 Study Group. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med 2015; 373:808-822. DOI:10.1056/NEJMoa1507198

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

Rodger, AJ, Cambiano V, Bruun T et al for the PARTNER Study Group. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, pro- spective, observational study. Lancet 2019, 393(10189), 2428–2438. DOI:10.1016/S0140-6736(19)30418-0

Langewitz W, Denz M, Keller A, et al. Spontaneous talking time at start of consultation in outpatient clinic: cohort study. BMJ 2002;325: 682-683 DOI:10.1136/bmj.7366.682

Fehr J, Nicca D, Langewitz W et al. Assessing a patient’s readiness to start and maintain ART (Revision 2015). Available at