Evaluating the combination of emtricitabine/ tenofovir alafenamide fumarate to reduce the risk of sexually acquired HIV-1-infection in at-risk adults

Reference

• Gerberding JL. Prophylaxis for occupational exposure to HIV. Ann Intern Med. 1996;125(6):497–501.
   PubMed Web of Science ®Google Scholar
• Grant RM, Lama JR, Anderson PL, et al., Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 363(27): 2587–2599. 2010. .
   PubMed Web of Science ®Google Scholar
• Baeten JM, Donnell D, Ndase P, et al., Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 367(5): 399–410. 2012. .
   PubMed Web of Science ®Google Scholar
• Thigpen MC, Kebaabetswe PM, Paxton LA, et al., Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 367(5): 423–434. 2012. .
   PubMed Web of Science ®Google Scholar
• McCormack S, Dunn DT, Desai M, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53–60.
   PubMed Web of Science ®Google Scholar
• Ruane PJ, DeJesus E, Berger D, et al. antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-Day monotherapy in HIV-1–Positive adults. J Acquir Immune Defic Syndr. 2013;63(4):449–455.
   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.
   PubMed Web of Science ®Google Scholar
• Gallant JE, Daar ES, Raffi F, et al. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016;3(4):e158–165.
   PubMed Web of Science ®Google Scholar
• Raffi F, Orkin C, Clarke A, et al. Brief report: long-Term (96-Week) efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV-infected, virologically suppressed adults. J Acquir Immune Defic Syndr. 2017;75(2):226–231.
   PubMed Web of Science ®Google Scholar
• Orkin C, DeJesus E, Ramgopal M, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017;4(5):e195–e204.
   PubMed Web of Science ®Google Scholar
• Ray AS, Fordyce MW, Hitchcock MJ. Tenofovir alafenamide: a novel prodrug of tenofovir for the treatment of human immunodeficiency virus. Antiviral Res. 2016;125:63–70.
   PubMed Web of Science ®Google Scholar
• Lampertico P, Buti M, Fung S, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020;5(5):441–453.
   PubMed Web of Science ®Google Scholar
• Agarwal K, Brunetto M, Seto WK, et al. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018;68(4):672–681.
   PubMed Web of Science ®Google Scholar
• Buti M, Gane E, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1(3):196–206.
   PubMed Web of Science ®Google Scholar
• Riddell J, Amico KR, Mayer KH. HIV preexposure prophylaxis: a review. JAMA. 2018;319(12):1261–1268.
   PubMed Web of Science ®Google Scholar
• Owens DK, Davidson KW, Krist AH, et al., Preexposure prophylaxis for the prevention of HIV infection: US preventive services task force recommendation statement. JAMA. 321(22): 2203–2213. 2019. .
   PubMed Web of Science ®Google Scholar
• Khalili J, Landovitz RJ. HIV preexposure prophylaxis-the role of primary care clinicians in ending the HIV epidemic. JAMA Intern Med 2019. 2020;180(1):126–130.
   Google Scholar
• Fauci AS, Redfield RR, Sigounas G, et al. Ending the HIV epidemic: a plan for the United States. JAMA. 2019;321(9):844–845.
   PubMed Web of Science ®Google Scholar
• Hojilla JC, Marcus JL, Silverberg MJ, et al. Early adopters of event-driven human immunodeficiency virus pre-exposure prophylaxis in a large healthcare system in San Francisco. Clin Infect Dis. 2020;71(10):2710-2712.
   PubMed Web of Science ®Google Scholar
• Molina JM, Charreau I, Spire B, et al., Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 4(9): e402–e410. 2017.
   PubMed Web of Science ®Google Scholar
• Mayer KH, Molina J-M, Thompson MA, et al., Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 396(10246): 239–254. 2020.
   PubMed Web of Science ®Google Scholar
• Krakower DS, Daskalakis DC, Feinberg J, et al. Tenofovir alafenamide for HIV preexposure prophylaxis: what can we discover about its true value? Ann Intern Med. 2020;172(4):281–282.
   PubMed Web of Science ®Google Scholar
• Spiegel HML. DISCOVER: much accomplished, but not yet for all. Lancet. 2020;396(10246):214–215.
   PubMed Web of Science ®Google Scholar
• Joseph Davey DL, Pintye J, Baeten JM, et al. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading? J Int AIDS Soc. 2020;23(1):e25426. .
   PubMed Web of Science ®Google Scholar
• Walensky RP, Horn T, McCann NC, et al. Comparative pricing of branded tenofovir alafenamide–emtricitabine relative to generic tenofovir disoproxil fumarate–emtricitabine for HIV preexposure prophylaxis. Ann Intern Med. 2020;172(9):583–590.
   PubMed Web of Science ®Google Scholar
• Das M, Ting J, Shreay S, et al. Comparative pricing of branded tenofovir alafenamide-emtricitabine relative to generic tenofovir disoproxil fumarate-emtricitabine for HIV preexposure prophylaxis. Ann Intern Med. 2020;173(6):506–507.
   PubMed Web of Science ®Google Scholar
• Walensky RP, Horn T, McCann NC, Freedberg KA, Paltiel AD: Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis. Ann Intern Med 2020;173:507–508.
   PubMed Web of Science ®Google Scholar
• Del Rio C, Armstrong WS. How much are we willing to pay for preexposure prophylaxis in the United States? Ann Intern Med. 2020;172(9):623–624.
   PubMed Web of Science ®Google Scholar
• Ogbuagu O, Podzamczer D, Salazar L, et al.: Longer-term safety of F/TAF and F/TDF for HIV PrEP: DISCOVER trial week-96 results. In CROI, Conference on Retroviruses and Opportunistic Infections. Edited by. Boston, MA; 2020.
   Google Scholar
• Schwarze-Zander C, Piduhn H, Boesecke C, et al. Switching tenofovir disoproxil fumarate to tenofovir alafenamide in a real life setting: what are the implications? HIV Med. 2020;21(6):378–385.
   PubMed Web of Science ®Google Scholar
• Glidden DV, Mulligan K, McMahan V, et al. Metabolic effects of preexposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine. Clin Infect Dis. 2018;67(3):411–419.
   PubMed Web of Science ®Google Scholar
• Mugwanya KK, Baeten JM. Next-generation preexposure prophylaxis: choices for effective HIV prevention. J Infect Dis. 2020;221(9):1387–1389.
   PubMed Web of Science ®Google Scholar
• Baeten JM, Palanee-Phillips T, Brown ER, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375(22):2121–2132.
   PubMed Web of Science ®Google Scholar
• Nel A, Van Niekerk N, Kapiga S, et al. Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women. N Engl J Med. 2016;375(22):2133–2143.
   PubMed Web of Science ®Google Scholar
• Matthews R. First-in-human trial of MK-8591-eluting implants demonstrate concentrations suitable for HIV prophylaxis for at least one year. editor. IAS, International AIDS Society. Mexico City: Mexico; 2019.
   Google Scholar
• Link JO, Rhee MS, Tse WC, et al. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020;584(7822):614–618.
   PubMed Web of Science ®Google Scholar
• Cohen J. Long-acting drug acts like a short-term AIDS vaccine. Science. 2020;368(6493):807.
   PubMed Web of Science ®Google Scholar
• Landovitz RJ, Li S, Eron JJ Jr., et al. Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial. Lancet HIV. 2020;7(7):e472–e481.
   PubMed Web of Science ®Google Scholar
• Scarsi KK. Chasing the cabotegravir tail: implications for prevention. Lancet HIV. 2020;7(7):e451–e453.
   PubMed Web of Science ®Google Scholar
• Oliveira M, Ibanescu RI, Anstett K, et al. Montreal Primary HIVCSG. Selective resistance profiles emerging in patient-derived clinical isolates with cabotegravir, bictegravir, dolutegravir, and elvitegravir. Retrovirology. 2018;15(1):56.
   PubMedGoogle Scholar
• Gunawardana M, Remedios-Chan M, Miller CS, et al. Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis. Antimicrob Agents Chemother. 2015;59(7):3913–3919.
   PubMed Web of Science ®Google Scholar
• Pons-Faudoa FP, Sizovs A, Di Trani N, et al. 2-Hydroxypropyl-beta-cyclodextrin-enhanced pharmacokinetics of cabotegravir from a nanofluidic implant for HIV pre-exposure prophylaxis. J Control Release. 2019;4:89–96.
   Google Scholar
• Chua CYX, Jain P, Ballerini A, et al. Transcutaneously refillable nanofluidic implant achieves sustained level of tenofovir diphosphate for HIV pre-exposure prophylaxis. J Control Release. 2016;125:315–325.
   Google Scholar
• Pons-Faudoa FP, Trani ND, Sizovs A, et al. Viral load Reduction in SHIV-positive nonhuman primates via long-acting subcutaneous tenofovir alafenamide fumarate release from a nanofluidic implant. Pharmaceutics. 2020;12(10):12. .
   Web of Science ®Google Scholar
• Su JT, Simpson SM, Sung S, et al. A subcutaneous implant of tenofovir alafenamide fumarate causes local inflammation and tissue necrosis in rabbits and macaques. Antimicrob Agents Chemother. 2020;64(3). 10.1128/AAC.01893-19.
   Web of Science ®Google Scholar
• Pons-Faudoa FP, Sizovs A, Shelton K, et al. Preventive efficacy of a tenofovir alafenamide fumarate nanofluidic implant in SHIV-challenged nonhuman primates. bioRxiv. 2020;12(10):981-993.
   Google Scholar
• Whitfield THF, John SA, Rendina HJ, et al. Why I quit pre-exposure prophylaxis (PrEP)? A mixed-method study exploring reasons for PrEP discontinuation and potential re-initiation among gay and bisexual men. AIDS Behav. 2018;22(11):3566–3575.
   PubMed Web of Science ®Google Scholar
• Huang YA, Tao G, Smith DK, et al. Persistence with HIV preexposure prophylaxis in the United states. Clin Infect Dis. 2021;72(3):379-385
   Web of Science ®Google Scholar
• Robles G, Sauermilch D, Gandhi M, et al. PrEP demonstration project showed superior adherence with tenofovir alafenamide/emtricitabine compared to tenofovir disoproxil fumarate/emtricitabine in a sample of partnered sexual minority men. AIDS Behav. 2020. 10.1007/s10461-020-03095-7
   Web of Science ®Google Scholar
• Glidden DV, Stirrup OT, Dunn DT. A bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial. Lancet HIV. 2020;7(11):e791–e796.
   PubMed Web of Science ®Google Scholar