next-generation islatravir implants projected to provide yearly hiv prophylaxis

doi: 10.1371/journal.pone.0248585. CROI: NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS. In a double-blind placebo-controlled phase 1 trial, islatravir implants were shown to be well tolerated. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Matthews R et al. 2) PATEL M, ZANG X, CAO Y, et al. LA CAB, at a dose of 600 mg given IM once every 8 weeks, reduces the need for daily administration and may provide a useful alternative for HIV pre-exposure prophylaxis (PrEP) . Correlati Such an MPT implant system could involve various configurations, such as two rods each containing a separate drug or a co-formulated implant that contains both a . Professor Sorana Segal-Maurer (right) presenting to CROI 2021. Oral Presentation. Conference on Retroviruses and Opportunistic Infections, abstract 87, 2021. 98 Research is also ongoing to develop an implant that can deliver either cabotegravir, rilpivirine, tenofovir alafenamide, or a tenofovir analogue . PLoS One. R. Matthews et al. doi: 10.1371/journal.pone.0248585. Introduction. Efficacy and safety of long-acting subcutaneous lenacapavir in phase 2/3 in heavily treatment-experienced people with HIV: week 26 results (Capella study). R. Matthews et al. Phase 1 study shows islatravir (ISL)-eluting implant as a favorable option for long-term HIV pre-exposure prophylaxis (PrEP). 3.matthews r, et al "next-generation islatravir implants projected to provide yearly hiv prophylaxis" croi 2021;abstract 88. Matthews R et al. 16. vCROI 2021, 88LB CROI 2021 15. Consequently, alternative approaches to HIV infection prevention have been pursued, and there have been a number of successes with differing levels of efficacy. The final CROI 2022 Program Guide is now available on CROI 2022 Resources page. next > | last >> pages: 1 . CROI: NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS. Hurt, MD, FIDSA Associate Professor of Medicine Director, North Carolina HIV Training & Education Center Director, Inpatient General ID Consultation Services Site PI, Ryan White HIV/AIDS Program Part D, UNC ID Clinic Institute for Global Health & Infectious Diseases University of North Carolina at Chapel Hill School of Medicine Dr. Hurt is supported by the Health Resources and . [9] . Islatravir PK thresholds & dose selection for monthly oral HIV-1 PrEP. 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. Late Breaking Oral Presentation. Next-generation islatravir implants projected to provide yearly HIV prophylaxis (CROI abstract 88). Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. 97 CROI 2021. Late Breaking Oral Presentation. Patel M et al. The t ½ described for implants of approximately 100 days might make it amenable to LA administration with dosing intervals of 1 year or more. T . Les implants de la prochaine génération sont radio-opaques. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Matthews R et al. Islatravir implants (containing only polymer and islatravir) have demonstrated the potential for yearly administration for PrEP. M. Patel et al. Despite significant progress in treatment efficacy, tolerability, and reducing pill burden, new agents are needed to address issues of resistance, drug-drug interactions, end organ disease, and adherence. Postdoctoral fellow in CUHK working on infectious disease epidemiology with network and phylogenetic analyses | Law student | Full-stack developer | MIET MIEEE. R. Matthews et al. Matthews R et al. Oral Presentation. This study shows the ability of a very novel formulation of islatravir (an implant) to last a year for PrEP. Late Breaking Oral Presentation. 2021 Mar 25;16(3):e0248585. For everyone else: read the study abstract, entitled "Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis" Summary by Larry Buhl; posted March 8 at 6:45 p.m., updated March 9 at 4:45 p.m. R. Matthews et al. They will explore the potential of a subdermal implant containing Islatravir as a long-acting pre-exposure prophylaxis (PrEP) option for up to a year. Select abstracts in the CROI 2021 program include: * Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. T . M. Patel et al. R. Matthews et al. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Currently, very few publications describe the development of MPT implants. Based on these findings, Merck plans to initiate a Phase 2 trial. At present, only two oral preexposure prophylaxis (PrEP) products are available, Truvada and Descovy. Patel M et al. 2021. HIV testing behaviors and willingness to receive oral rapid HIV testing among dental patients in Xi'an, China . Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . next-generation-islatravir-implants-projected-to . T . Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Because of its makeup, it's suitable for long-acting delivery. Oral Presentation. Conference on Retroviruses and Opportunistic Infections 2021; Late-Breaking Abstract No. An experimental islatravir implant that can be replaced just once a year could one day be a convenient new option for HIV pre-exposure prophylaxis (PrEP), according to early study results presented this week at the virtual Conference on Retroviruses . Resistance Profile of MK-8507, a Novel NNRTI Suitable for Weekly Oral HIV Treatment. We encourage you to login and…. Early studies also suggest that a long-acting islatravir implant could provide protection for one year. M. Patel et al. Oral Presentation. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Resistance Profile of MK-8507, a Novel NNRTI Suitable for Weekly Oral HIV Treatment. "Islatravir-eluting implants. 4.Segal-Maurer S, et al "Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH" CROI 2021; Abstract 127. Data from a randomized phase I trial in adults without HIV-1 published in Nature Medicine suggest that subdermal implant of islatravir, a nucleoside reverse transcriptase translocation inhibitor, is a promising pre-exposure prophylaxis (PrEP) option for HIV-1. 0 log at day 7 in treatment-naive adults with HIV-1 infection and were generally . Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Back in December, FDA placed clinical holds on the INDs for oral and implant formulations of islatravir for HIV-1 pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for HIV . Moreover, islatravir-eluting implants for yearly HIV PrEP have been evaluated for safety, tolerability, and pharmacokinetics in healthy HIV-negative men and women. We are opening the conference with the Scott M. Hammer Workshop for New…. A second oral presentation reported that an islatravir implant would provide PrEP cover for a year. HIV Incidence Y 4 infections 36 infections 0.2 1.86 Hazard Ratio (95% CI) 89% reduced hazard of HIV among CAB recipients, compared with FTC/TDF (95%CI: 69%, 99%; p=0.000027) Favors CAB Favors FTC/TDF 0.11 0 1 2 ty IM CAB-LA was statistically superiorto oral FTC/TDF for preventing HIV Welcome to CROI 2022! Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Islatravir PK thresholds & dose selection for monthly oral HIV-1 PrEP. Conference on Retroviruses and Opportunistic Infections, abstract 88, 2021. croi: next-generation islatravir implants projected to provide yearly hiv prophylaxis - (03/08/21) CROI: ISLATRAVIR PK THRESHOLD & DOSE SELECTION FOR MONTHLY ORAL HIV-1 PrEP - (03/08/21) March 8, 2021 11:40 am EST A study at CROI 2021 modelled pooled PK data from HIV . Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Conference on Retroviruses and Opportunistic Infections, abstract 88, 2021. The ability to successfully develop a safe and effective vaccine for the prevention of HIV infection has proven challenging. Lancet 2007;370:89-93. Next- Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS (ABSTRACT 88) Randolph P Matthews. Conclusion: Next-generation radiopaque islatravir-eluting implants provide drug release projected to be sufficient for HIV prophylaxis for at least one year. CROI 2021, 6 - 10 March 2021. Late Breaking Oral Presentation. Resistance Profile of MK-8507, a Novel NNRTI Suitable for Weekly Oral HIV Treatment. This review covers novel ART agents . Molina JM, et al. Lenacapavir, an experimental HIV capsid inhibitor, led to rapid viral load reduction in highly treatment-experienced people with multidrug-resistant virus, according to a study presented yesterday at the . It eluting implants seems to support sufficient drug release for is indicated, after an oral lead-in period, as a complete regimen for HIV prophylaxis for at least 1 year.64 Islatravir implants are also the maintenance treatment of HIV-1 infection in adults, replacing currently being investigated in combination with other LA drugs for a current . [Google Scholar] Oral abstract 88. https://www.croiconference.org/abstract/next-generation-islatravir-implants-projected-to-provide-yearly-hiv-prophylaxis/ This report was first posted on 8 March 2021. The CROI 2022 Platform is now available to all registered attendees. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 PrEP. 2021 Mar 25;16(3):e0248585. Hong Kong R. Matthews et al. 88 6 Segal-Maurer S et al. Das neue NRTTI Islatravir als subdermales Implantat hat in einer Studie-1-Studie an 36 Teilnehmern das Potential für die einmal jährliche Applikation im Rahmen einer PrEP gezeigt. Late Breaking Oral Presentation. 14. Autores do estudo: Randolph P . Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 PrEP. ISLATRAVIR PK THRESHOLD & DOSE SELECTION FOR MONTHLY ORAL HIV-1 PREP (ABSTRACT . ISL is a nucleoside reverse transcriptase translocation inhibitor with high antiretroviral potency necessary for long-term drug delivery from a small implant. Die Verträglichkeit war gut. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. 64 Islatravir implants are also . 57, 63 Indeed, the results of a Phase I study with radiopaque islatravir-eluting implants seems to support sufficient drug release for HIV prophylaxis for at least 1 year. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . detected only by the more sensitive next generation sequencing, but with evidence of a viral rebound in the few days before ART at day 10. . Next Generation ISL-eluting Implants Projected to Provide Yearly HIV Prophylaxis Matthew R. CROI 2021 56 mg implant projected to lead to concentrations above threshold for 52 weeks Lenacapavir: First in Class Long-Acting HIV Capsid Inhibitor for Treatment and Prevention • Small molecule which disrupts the functions of HIV capsid protein Descovy . Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS. Long-acting formulations are being developed to overcome barriers—primarily, adherence—presented by daily oral therapy. PrEP. #148 • daily doxycycline in msm on prep for prevention of sexually transmitted infections # 709 • nuevos fÁrmacos y formulaciones para la prep • phase 1 . Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis We also saw data from a phase I study investigating the pharmacokinetics, safety, and tolerability of implants containing 48 mg, 52 mg, or 56 mg of islatravir , a next-generation nucleoside reverse transcription translocation inhibitor (NRTTI) with a long half-life . MK-8591-043 - A Phase 2a PrEP study evaluating islatravir implant once-yearly in individuals at low risk for HIV-1 infection (study had not yet opened enrollment) The following studies have been . In March, Merck announced promising results from an early human safety trial of an islatravir-infused subdermal implant and its plans to begin a larger, midstage study of the implant as protection against HIV lasting up to 12 months. Islatravir-eluting implants appear to be well tolerated, and the results from this trial support further study of these implants in a larger, longer Phase 2 trial. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . The implants inserted with a Nexplanon applicator were well tolerated, and specifically the 54 and 62 mg implants were found to be effective in maintaining islatravir-triphosphate . Resistance Prole of MK-8507, a Novel NNRTI Suitable for Weekly Oral HIV Treatment. Late Breaking Oral Presentation. Results for both pairs of trials are expected in 2024. HIV testing behaviors and willingness to receive oral rapid HIV testing among dental patients in Xi'an, China . The reverse transcriptase (RT) of the human immunodeficiency virus type 1 (HIV-1) is a virally encoded RNA- and DNA-dependent polymerase that represents an important target for antiretroviral therapeutics (1,- 4).RT also possesses a ribonuclease H (RNase H) activity that degrades the RNA of RNA/DNA replication intermediates. Innovations in HIV-1 pre-exposure prophylaxis (PrEP) are needed to address the global HIV epidemic and meet the diverse needs of individuals at risk of acquiring HIV-1. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Molina JM, Charreau I, Spire B, et al. . A more recent study projected that these implants could provide HIV prophylaxis for at least one year . 4.Segal-Maurer S, et al "Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH" CROI 2021; Abstract 127. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. It is in clinical trials to evaluate a variety of doses, dosage forms, and dosing frequency, combined with other antiretroviral drugs to treat HIV-1 infection , And as a single drug to prevent HIV-1 infection. R. Matthews et al. Several long-acting modalities are currently under investigation for both HIV treatment and prophylaxis, including oral, injectable, implant, antibody therapy, and vaginal ring. M. Patel et al. 1) MATHEUS RP, ZANG X, BARNETT S, et al. Late Breaking Oral Presentation. Oral Presentation. HIV capsid inhibitor offers new option for people with highly resistant HIV. Pre-exposure prophylaxis for HIV infection: what if it works? Islatravir (ISL) is the first nucleoside reverse transcriptase translocation inhibitor (NRTTI) in development for the treatment and prevention of HIV-1. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. •HIV prevention efficacy trial of a long-acting oral ISL among young African women as HIV-1 pre-exposure prophylaxis -MSD/ICRC. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 PrEP. 2017;4(9): e402-e410. Merck also projected the implant will provide drug concentrations likely above threshold for one year at the 56 mg dose, and the company is planning to initiate a phase 2 trial to further explore the potential of a subdermal implant containing islatravir for PrEP for up to 12 months. Encouraging results regarding adherence . We heard data about possibly implants that could provide yearly prophylaxis—a whole year of prophylaxis with an implant—and maybe monthly oral therapy with that same compound. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Não é que o islatravir seja vai ser a resposta, mas será outra abordagem que algumas pessoas podem usar." _____ O estudo original foi publicado na Conference on Retroviruses and Opportunistic Infections * "NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS" - 2021. In the oral presentation "Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis," the researcher presented data on the Phase 1 trial of islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI). The latest Tweets from TH Kwan, PhD (@tszhokwan). Late Breaking Oral Presentation. R. Matthews et al. for infant HIV prophylaxis and treatment. The implant was projected to provide drug concentrations likely above the threshold for one year at the highest dose. Lancet HIV. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . Res. croi 2021: prevenciÓn Índice • estudios clÍnicos • prep efficacy over the first 3 years of implementation in france: a nationwide study #698 • incidence of hiv infection with daily or on-demand oral prep with tdf/ftc in france. •Double-blind placebo-controlled multicenter Phase I trial •Groups •Single islatravir-eluting implant (48 mg, 52 mg, or 56 mg) •Placebo implant •Implant placed in participants at low risk to acquire HIV for 12 weeks 16. Islatravir PK threshold and dose selection for monthly oral HIV-1 PrEP. LA CAB was superior to daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) in preventing HIV infection among men who have sex with men (MSM) and . Conference on Retroviruses and Opportunistic Infections, abstract 88, CROI 2021. Based on preclinical data, two doses were assessed: 54 mg and 62 mg. Islatravir implants at both doses were safe and resulted in mean concentrations above the pharmacokinetic threshold through 12 weeks, warranting further investigation of islatravir implants as a potential HIV prevention strategy. Why this matters . suitable for HIV prophylaxis for at . Late Breaking Oral Presentation. R. Matthews et al. Christopher B. Islatravir PK thresholds & dose selection for monthly oral HIV-1 PrEP. We heard about lenacapavir, a long-acting antiviral that could be very, very useful, and that the company is very interested in and aggressively pursuing for prevention. •A slow-release yearly implant based on Implanon®/Nexplanon® and once monthly oral dosing could broaden access to PrEP. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. A next-generation implant maintained adequate drug levels for at least a year in an early study. The 62 mg implant provided drug release projected to be sufficient for HIV prophylaxis for at least one year, supporting the potential of the islatravir implant as a once yearly PrEP option. 88 CROI 2021. Merck & Co, Inc, Kenilworth, NJ, USA . Next Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. In addition, islatravir is being studied for pre-exposure prophylaxis and post-exposure prophylaxis (possibly using weekly or monthly doses). Late Breaking Oral Presentation. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. Purpose of Review Combination antiretroviral therapy (cART) has had dramatic effects on morbidity and mortality for persons living with HIV (PLWH). PLoS One. : Potent antiviral activity of lenacapavir in phase 2/3 in heavily ART-experienced PWH. Oral Presentation. "Next-generation radiopaque islatravir-eluting implants provide drug release projected to be sufficient for HIV prophylaxis for at least one year," Matthews said. Long-acting HIV-prevention drugs may be key to beating the epidemic in the U.S. New forms of pre-exposure prophylaxis, or PrEP, could be used by groups who find daily preventive medications too . Paxton LA, Hope T, Jaffe HW. Conference on Retroviruses and Opportunistic Infections, abstract 88, CROI 2021. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Conference on Retroviruses and Opportunistic Infections, Abstract 88, 2021. NATAP | CROI 2021 March 6-10 In Proceedings of the Conference on Retroviruses and Opportunistic Infections (CROI), Virtual, 3-6 March 2021. In the oral presentation "Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis," the researcher presented data on the Phase 1 trial of islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI). Les implants de la prochaine génération sont radio-opaques. The 62 mg implant provided drug release projected to be sufficient for HIV prophylaxis for at least one year, supporting the potential of the islatravir implant as a once yearly PrEP option. Because of its makeup, it's suitable for long-acting delivery. ISL administered as a long-acting subdermal implant for HIV PrEP can last up to one year [ 52 , 61 ] The development of the drug-loaded implant was tested with various bio- Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 . NATAP | CROI 2021 March 6-10 14. A phase II study of children and adolescents is also planned. T . R. Matthews et al . Patel M et al. Oral Presentation. Presented at CROI 2021. 3.matthews r, et al "next-generation islatravir implants projected to provide yearly hiv prophylaxis" croi 2021;abstract 88. Late Breaking Oral Presentation. Late Breaking Oral Presentation. Hopes are high for a new implant that could provide year-long protection against HIV for people who do not have the virus. Next-Generation Islatravir Implants Projected to Provide Yearly HIV Prophylaxis. R. Matthews et al. October 4, 2021. Islatravir is a new type of nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development by Merck. The device, a new venture by Merck, has proven a success in rodents and . Watch the NEXT-GENERATION ISLATRAVIR IMPLANTS PROJECTED TO PROVIDE YEARLY HIV PROPHYLAXIS CROI Webcast by Randolph P Matthews from the session HIV TREATMENT AND PREVENTION: NEW OPPORTUNITIES TO OPTIMIZE DRUG DOSING, ADHERENCE, AND ANTIRETROVIRAL THERAPY. R. Matthews et al. Oral Presentation. Next-generation islatravir implants projected to provide yearly HIV prophylaxis. Conference on Retroviruses and Opportunistic Infections, abstract 87, 2021. Islatravir PK Threshold & Dose Selection for Monthly Oral HIV-1 PrEP. 15. Res.

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