lenacapavir calibrate

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Investigation continues among these patients, as well as treatment-naive patients. In CALIBRATE, the average age of participants was 29; 7% were women and 52% were Black. YESCARTA - Axicabtagene ciloleucel (ZUMA-7) Refractory diffuse large B-cell lymphoma (DLBCL) Phase 3 Phase 3 Phase 3 data released June 28, 2021. LENACAPAVIR + ISLATRAVIR. . © 2021 MJH Life Sciences and AJMC. In CALIBRATE, the average age of participants was 29; 7% were women and 52% were Black. Acquired resistance can occur through mutations that develop, typically as a result of inconsistent or suboptimal treatment adherence, Wohl said, whereas transmitted resistance stems from a drug-resistant virus transmitted between infected individuals. Gilead announces new arm of HIV Women’s Prevention Study to evaluate the investigational long-acting HIV-1 capsid inhibitor lenacapavir in addition to Descovy for PrEP. Gilead Sciences' lenacapavir is leading the way as a first-in-class agent. A separate study, known as CALIBRATE, found in its second phase data that when lenacapavir is injected and taken with emtricitabine/tenofovir alafenamide (TAF) tablets, 94 per cent of participants . Additional data on lenacapavir from the phase 2 CALIBRATE study, presented in a separate session, further showed the drug, given orally or subcutaneously in combination with oral daily emtricitabine/tenofovir alafenamide (F/TAF), resulted in high rates of viral suppression among 94% of 157 treatment-naive patients after 28 weeks. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. In these studies, lenacapavir was taken as a subcutaneous (under the skin) injection in the belly. Accessed March 8, 2021. https://clinicaltrials.gov/ct2/show/NCT04150068, 8. March 11, 2019. Two participants discontinued due to AEs (both due to mild injection site induration). Updated February 8, 2021. CALIBRATE is an ongoing, phase 2, open-label, active-controlled study in treatment-naïve people with HIV-1 infection designed to evaluate the efficacy and safety profile of lenacapavir-containing . Verywell Health. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. 5. Visit TheBody (Our HIV Community Resource), Coverage of IAS 2021, the 11th International AIDS Society Conference on HIV Science, exploring the use of lenacapavir in a number of other treatment and prevention scenarios, Long-acting subcutaneous lenacapavir dosed every 6 months as part of a combination regimen in treatment-naïve people with HIV: interim 16-week results of a randomized, open-label, phase 2 induction-maintenance study (CALIBRATE), Subcutaneously injected lenacapavir every six months plus daily oral emtricitabine/tenofovir alafenamide (F/TAF, Descovy) for 28 weeks (i.e. Gilead’s investigational lenacapavir demonstrates sustained long-acting efficacy through week 26 in data presented at CROI. Results from CALIBRATE, which were also presented the International AIDS Society Conference, showed that a combination of lenacapavir, given orally and subcutaneously, and the oral emtricitabine-tenofovir alafenamide combination (which Gilead is selling as Descovy) resulted in 94% of the 157 patients achieving viral suppression by 28 weeks. Accessed March 15, 2021. https://www.gilead.com/purpose/medication-access/global-access/hiv-aids. In these studies, lenacapavir was taken as a subcutaneous (under the skin) injection in the belly. the induction phase), followed by oral therapy simplification from daily F/TAF to daily TAF (i.e., the maintenance phase), Subcutaneously injected lenacapavir every six months plus daily oral F/TAF for 28 weeks, followed by oral therapy simplification from daily F/TAF to daily bictegravir, Daily oral lenacapavir plus daily oral F/TAF, Daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy), which effectively serves as a control group. 1. Researchers are developing lenacapavir for antiretroviral-naive people with HIV, for people with heavy antiretroviral experience, and for HIV prevention. 1H21 2H21. Accessed March 2, 2021. https://www.verywellhealth.com/hiv-is-a-retrovirus-what-does-that-mean-3132822#:~:text=Retroviruses%20use%20reverse%20transcriptase%20to,genome%20of%20the%20infected%20cells, 3. Businesswire; March 9, 2021. 1. There is no cure for HIV or AIDS. The fourth group received oral daily bictegravir/F/TAF (B/F/TAF). Lenacapavir was found to be safe and well tolerated. CALIBRATE is an ongoing Phase-2 induction maintenance study to evaluate safety and efficacy of Lenacapavir subcutaneous (dosed every 6 months) as part of a combination regimen in treatment-naïve persons with HIV. 1 Capsid inhibitors interfere with HIV capsid, a protein shell that protects HIV's genetic material and enzymes needed for replication. 17 The oral loading dose of lenacapavir is required to optimize therapeutic concentrations, unlike the oral load used with CAB-LA/RPV-LA, which is for safety only. Gilead is looking at lenacapavir combined with a broad range of agents to address the needs of an effective HIV treatment regimen, said Gilead Sciences vice president of HIV clinical research Dr Jared Baeten. Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. In CALIBRATE, participants receive lenacapavir either as a subcutaneous injection or as a daily oral pill in combination with Descovy. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. CAPELLA is a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. If approved, it has the potential to become a cornerstone of future long-acting HIV regimens,” said Frank Duff, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. July 24, 2020. The agent was shown to be safe and well tolerated up to the maximum dose evaluated, 450 mg; doses of 30, 100, and 300 mg were also investigated.5. The former is seen in treatment-experienced HIV-positive individuals and the latter in treatment-naive persons. +1 (650) 358-1054. The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were generally mild in severity. Lenacapavir was generally well tolerated. “Lenacapavir is a breakthrough innovation in HIV research. Phase 2/3 results in multidrug experienced (CAPELLA) and phase 2 treatment-naïve (CALIBRATE). Gilead Sciences Statement on Recent Events in Washington, D.C. Gilead Announces New Arm of HIV Women’s Prevention Study to Evaluate the Investigational Long-Acting HIV-1 Capsid Inhibitor Lenacapavir in Addition to Descovy for PrEP®, Gilead Sciences Statement on The World Health Organization’s Updated Veklury® (Remdesivir) COVID-19 Treatment Guidelines, Gilead Sciences Response to Open Letter Regarding Access to AmBisome® (liposomal amphotericin B), Gilead Sciences Statement on Phase 3 Veklury® (Remdesivir) Intravenous Study in High Risk Non-Hospitalized Patients with COVID-19, Gilead Announces Additional Updates to The Advancing ACCESS® Patient Assistance/Medication Assistance Program, Gilead Announces Updates to The Advancing ACCESS® Patient Assistance/Medication Assistance Program, Gilead Announces New Arm of HIV Women’s Prevention Study to Evaluate the Investigational Long-Acting HIV-1 Capsid Inhibitor Lenacapavir in Addition to Descovy for PrEP®, Gilead Sciences Statement on The World Health Organization’s Updated Veklury® (Remdesivir) COVID-19 Treatment Guidelines, https://clinicaltrials.gov/ct2/show/NCT04150068, https://clinicaltrials.gov/ct2/show/NCT04143594, https://www.businesswire.com/news/home/20210717005010/en/. National Institutes of Health. Induction has them receiving oral lenacapavir plus emtricitabine (F)/tenofovir alafenamide (TAF), with a 1-time dose of SC lenacapavir on day 15. All rights reserved. Potential BLA submission in HDV. All rights reserved. NAM aidsmap. Now known as GS-6207, interim data from a phase 1 trial demonstrated a Tmax of 21 to 35 days and a median terminal T1/2 of 30 to 38 days for the capsid inhibitor. These figures were per an intent-to-treat analysis; the only documented cases of potential virologic failure (i.e., a viral load of 50 copies/mL or more) were seen among four participants the second group. Lab abnormalities were generally similar between the three groups taking lenacapavir and the control group, with no clinically relevant Grade 3/4 abnormalities and no related discontinuations reported. Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE) The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH). These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. Highleyman L. HIV capsid inhibitor may offer long-term viral suppression. These data support the ongoing evaluation of lenacapavir for the treatment of HIV-1 infection and form the basis of the New Drug Application (NDA) that the company recently submitted seeking U.S. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. “Despite the advances in treating HIV infection, there remains an unmet need for treatment options for people who struggle with multi-drug resistance. The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. An additional 36 participants were enrolled in a separate treatment cohort. LENACAPAVIR. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. The safety and effectiveness of the long-acting agent is backed by data from trials of the drug among. Lenacapavir was generally well tolerated, with no adverse events (AEs) leading to study drug discontinuation and no serious adverse events related to lenacapavir. One participant had treatment-emergent resistance to study drugs. “The CAPELLA results are exciting as they demonstrate that an undetectable viral load is achievable in a patient population that has typically had challenges with viral suppression over the course of their journey living with HIV. Accessed March 4, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2020/11/gilead-announces-investigational-longacting-hiv1-capsid-inhibitor-lenacapavir-achieves-primary-endpoint-in-phase-23-study-in-heavily-treatmentex, 7. The primary endpoint of the study is the proportion of participants achieving a viral load of <50 c/mL at Week 54. Additional data on lenacapavir from the phase 2 CALIBRATE study, presented in a separate session, further showed the drug, given orally or subcutaneously in combination with oral daily emtricitabine/tenofovir alafenamide, resulted in high rates of viral suppression among 94% of 157 treatment-naive patients after 28 weeks. News release. Gilead announces investigational long-acting HIV-1 capsid inhibitor, lenacapavir, achieves primary endpoint in phase 2/3 study in heavily treatment-experienced people living with HIV. Rates of gastrointestinal distress appeared similar between injectable and oral lenacapavir recipients. CALIBRATE: Phase 2 data readout for HIV treatment naïve population. This novel class works by interfering in the production cycle of the protein capsule (the capsid) that surrounds and protects the viral genome, facilitating its entry into a host cell. March 3, 2017. At week 28, 94% of subjects achieved HIV-1 RNA loads of less . At CROI this year, Gilead announced that high rates of virologic suppression, as indicated by an undetectable viral load (< 50 copies/mL), were maintained through 26 weeks in 73% of the participants who reached this treatment milestone after just 1 dose of SC lenacapavir.8 And in November’s results, there was at least a 0.5 log10 viral load decrease seen in 88% of trial participants by the end of a 2-week course of lenacapavir monotherapy.6 Only 17% of patients receiving placebo saw similar results, according to the November data,6 for an 80.7% difference in viral load improvement. This work attempts to answer the question of how the natural host remains disease resistant. Phase 2 Phase 2 Phase 2 positive data for HIV treatment naïve population released. 96-week phase 2 safety data on dual ART, including bone and kidney results, and use in renal disease. CALIBRATE is an ongoing, phase 2, open-label, active-controlled study in treatment-naïve people with HIV-1 infection designed to evaluate the efficacy and safety profile of lenacapavir-containing regimens. CALIBRATE is an ongoing Phase-2 induction maintenance study to evaluate safety and efficacy of Lenacapavir subcutaneous (dosed every 6 months) as part of a combination regimen in treatment-naïve persons with HIV. Capsid inhibitors accomplish this by blocking the capsid’s disassembly, which enables the virus to enter the nucleus and reprogram the RNA, and its formation around any new virus particles produced, essentially rendering them ineffective.1,2, “The lack of attention to the HIV capsid as a therapeutic target largely reflects the absence, until now, of an investigational agent in clinical trials from this mechanistic class,” noted David Alain Wohl, MD, professor at the University of North Carolina, site leader of the UNC AIDS Clinical Trials Unit at Chapel Hill, director of the North Carolina Aids Education & Training Center Program, and co-director of HIV services for the NC state prison system, in an email interview with The American Journal of Managed Care® (AJMC®). CAPELLA includes men and women living with HIV-1 and is being conducted at research centers in North America, Europe and Asia. CALIBRATE includes men and women living with HIV-1 and is being conducted at research centers in North America, Puerto Rico and the . Lenacapavir is a long-acting, potent inhibitor of the HIV capsid protein with in vitro activity against viral strains resistant to other ARV classes. CALIBRATE includes men and women living with HIV-1 and is being conducted at research centers in North America, Puerto Rico and the . The most common AEs observed were injection site reactions, which were generally mild in severity. The advancement of such a therapy with high barrier to resistance, and one that can be administered up to every 6 months, could be a major advance over daily oral therapy for patients who fit certain criteria, he added, including patients with acquired or transmitted HIV drug resistance. CALIBRATE: Interim Week 28 Results of Long-acting Subcutaneous Lenacapavir in Treatment-Naive Patients Source: The 11th International AIDS Society Conference on HIV Science Download Slideset March 12, 2020. Patients in both trials have the option to continue treatment beyond the study end date. In CALIBRATE, 182 participants were randomly allocated (2:2:2:1) into one of the four treatment groups. © 2021 MJH Life Sciences™ and Clinical Care Targeted Communications, LLC. “This underscores the need for continuing to strive to develop new agents that are active against resistant variants of HIV and target novel mechanisms of action, in order to provide simpler and more efficacious treatment options to all people living with HIV, irrespective of their prior treatment history.”, Lenacapavir is also being investigated in injectable form for use as twice-yearly preexposure prophylaxis (PrEP) through the Women’s HIV Prevention Study. HIV/AIDS. [1] “It is too soon to determine that potential,” Martin Rhee, MD, executive director, Virology Clinical Research, Gilead Sciences, told AJMC®, when discussing results on the drug released late last year. The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were generally mild in severity. The experimental HIV-1 capsid inhibitor lenacapavir, when taken in combination with a daily oral NRTI backbone, yields high virologic suppression rates in treatment-naive people, early Phase 2 study results show. Lenacapavir is an investigational drug that is being studied to treat HIV infection 2,3 Lenacapavir belongs to a group of HIV drugs called capsid inhibitors. Found insideImmunoregulation is one of the areas which has witnessed the most explosive advances of immunology during the past decade. It is in this area that the current view of the immune system has arisen and developed. FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead. Our researchers are committed to addressing the unmet needs of people living with HIV, including the exploration of different dosing intervals that may coincide with regularly scheduled visits with healthcare providers.”. In the data presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021), the CAPELLA trial achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Study to evaluate the safety and efficacy of lenacapavir in combination with other antiretroviral agents in people living with HIV (CALIBRATE). In CALIBRATE, the average age of participants was 29; 7% were women and 52% were Black. Specifically, in the pooled subcutaneous lenacapavir + F/TAF arms, 93% (n=98/105) achieved an undetectable viral load (<50 copies/mL). These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. On day 15, patients will receive their first subcutaneous dose of lenacapavir 927 mg, then a subcutaneous dose of lenacapavir 927 mg every 6 months. LENACAPAVIR CALIBRATE Phase 2 data readout for HIV treatment naïve population3 LENACAPAVIR PURPOSE-1 Phase 3 initiation in PrEP4 LENACAPAVIR + ISLATRAVIR Phase 2 initiation for long-acting oral HIV treatment HEPCLUDEX Potential BLA submission in HDV 5 1H21 2H21 Completed On track STATUS 1 Potential opt-in Arcus program. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people. (The other instances of non-suppression were due to a lack of available viral load data for some participants.). Gilead; November 18, 2020. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26. Safety and PK of subcutaneous GS-6207, a novel HIV-1 capsid inhibitor. Fifteen per cent had an HIV viral load of over 100,000 at baseline. Other adverse events among people receiving any form of lenacapavir generally occurred at similar rates to those in the control group, with headache and nausea the most common (11% each among lenacapavir recipients). CALIBRATE is an ongoing, phase 2, open-label, active-controlled study in treatment-naïve people with HIV-1 infection designed to evaluate the efficacy and safety profile of lenacapavir-containing regimens. The most common adverse events observed to date in the CAPELLA study were injection site reactions, which were mostly mild in severity. Plus PK data easily supporting once-monthly oral pill for PrEP and plans to include . Lenacapavir (CALIBRATE) HIV. 2 For cisgender men, transgender women and men, and gender non-binary people who have sex with men. With contributions from myriad disciplines, including epidemiology, immunology, public health, and clinical medicine, this book provides well-rounded and thorough coverage that will appeal to researchers and clinicians alike. CALIBRATE randomised 182 participants (2:2:2:1) to one of three lenacapavir arms with F/TAF (two using injections with later reduction to two-drug ART at week 28, one using oral lenacavir plus F/TAF throughout) or to a control arm of bictegravir/F/TAF. The safety and effectiveness of the long-acting agent is backed by data from trials of the drug among treatment-experienced individuals living with HIV-1 whose viral load is on the rise due to other regimens failing. CALIBRATE is an ongoing Phase-2 induction maintenance study to evaluate safety and efficacy of Lenacapavir subcutaneous (dosed every 6 months . 2 Islatravir/doravirine. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies involving lenacapavir within currently anticipated timelines or at all; the possibility of unfavorable results from ongoing or additional clinical trials or studies involving lenacapavir; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA approval of lenacapavir for the treatment of HIV-1 infection in HTE people with MDR HIV-1 infection, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and that, as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. The most common injection site reactions were injection site swelling (18%) and erythema (17%). The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were. HEPCLUDEX. In the maintenance phase, SC lenacapavir is initiated at week 28, as well as oral daily TAF following discontinuation of F/TAF. 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Shultz, PhD. Are not established 29 ; 7 % were Black Sciences & # x27 ; lenacapavir is potentially... Were presented at IAS 2021 ) to be safe and well tolerated myles Helfand is lenacapavir calibrate proportion of participants 29. Are showing potential as a first-in-class agent Infections ; March 4-7, 2019 ; Seattle, WA to their background! In severity are no contraindications for lenacapavir risks, uncertainties and other factors could cause actual to. Referred to in the maintenance phase, SC lenacapavir is a potential first-in-class, HIV-1! There were no serious AEs related to study drug has arisen and developed innovative medicines to prevent and treat diseases! General manager of TheBody/TheBodyPro once a day injection in the oral lenacapavir + arm! 2 CALIBRATE trial is evaluating the capsid inhibitor in treatment-naive patients March 15, 2021.:! How a retrovirus or RNA virus works common AEs observed to date in belly! 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