Presentations include six-year data for the investigational regimen of cabotegravir and rilpivirine.
","publishDateTime":"02/10/2019 00:00:00","publishDate":"02 October 2019","forInvestorsAndMediaOnlyText":"","shortDescription":"Presentations include six-year data for the investigational regimen of cabotegravir and rilpivirine.","image":null,"downloadLink":null,"tags":[]},"components":[{"type":"rich-text","text":"Issued: London, UK
\nViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced it will present 20 abstracts from the company’s HIV research and development programs, as well as its community-based research initiatives, at the Infectious Disease Society of America (IDSA) IDWeek 2019, 2-6 October, in Washington, DC. The data highlight ViiV Healthcare’s commitment to not only develop innovative medicines that address the unmet need that still exists in HIV treatment, but also advance understanding of the emotional experiences and overall well-being of those who live with HIV.
\nKimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: “People living with HIV are increasingly asking for a variety of treatment options to meet their evolving needs, and our data presentations at IDWeek 2019 show how ViiV Healthcare is delivering on this request. We are excited to be sharing data that describe the longer-term efficacy and safety of our 2-drug regimens and additional information relating to patient preferences for our long-acting regimen. We will also be presenting data that underscore the need to place additional attention on the role of mental health and well-being, especially as individuals age while living with HIV.”
\nData supporting 2-drug regimens (2DRs)
\nViiV Healthcare is presenting data that describe the longer-term safety and efficacy of 2DRs, as well as patient adherence and preference with respect to these treatment regimens:
\nData on the impact of HIV on the community
\nRecognising that achieving viral suppression is only one aspect of living with HIV, ViiV Healthcare will present data from innovative research initiatives that help to better understand the factors that contribute to quality of life in people living with HIV:
\nThe full list of data that will be presented by ViiV Healthcare at IDWeek 2019 is listed below:
\nCabotegravir and rilpivirine
\n| \n Format \n | \n\n Abstract Title \n | \n\n Author / Presenter \n | \n\n Abstract / Poster Number \n | \n\n Time (ET) / Location \n | \n
| \n Oral \n | \n\n Patient Adherence to Long-Acting Cabotegravir + Rilpivirine Through 48 Weeks of Maintenance Therapy in the Phase 3 ATLAS and FLAIR Studies \n | \n\n Paula Teichner \n | \n\n 884 \n | \n\n Thurs 3 Oct, 3:30 – 3:45 PM \n\n Room 144 ABC \n | \n
| \n Poster \n | \n\n Population Pharmacokinetic (PPK) Modeling and Simulation of Long-Acting (LA) Cabotegravir (CAB) to Inform Strategies following Dosing Interruptions in HIV-1 Infected Subjects \n | \n\n Susan Ford \n | \n\n 1532 \n | \n\n Fri 4 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Women's Perspectives on and Experiences with Long-acting Injectable Anti-retroviral Therapy in the United States and Spain: the Potential Role of Gender in Patient Preferences \n | \n\n Wendy Davis \n | \n\n 2497 \n | \n\n Sat 5 Oct, \n12:15 – 1:30 PM \n\n Hall B + C \n | \n
| \n Poster \n | \n\n Pharmacokinetics of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injectables in HIV-infected Individuals through 48 Weeks in the FLAIR and ATLAS Phase 3 Studies \n | \n\n Parul Patel \n | \n\n 2495 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Perceptions of and Preferences for Oral or Long-Acting Injectable Antiretroviral Treatment Regimens in the United States and Canada \n | \n\n Cindy Garris \n | \n\n 2499 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Oral \n | \n\n Long term efficacy, safety and durability of CAB and RPV as two drug oral maintenance therapy – LATTE Week 312 results \n | \n\n David A Margolis \n | \n\n 2840 \n | \n\n Sat 5 Oct, \n Room 144 \n | \n
Dovato (dolutegravir/lamivudine)
| \n Format \n | \n\n Abstract Title \n | \n\n Author / Presenter \n | \n\n Abstract / Poster Number \n | \n\n Time (ET) / Location \n | \n
| \n Oral \n | \n\n Durable Efficacy of Two-Drug Regimen (2DR) of Dolutegravir (DTG) plus Lamivudine (3TC) in Antiretroviral Treatment-Naïve Adults with HIV-1 Infection at 96 Weeks: Subgroup Analyses in the GEMINI Studies \n | \n\n Jean van Wyk \n | \n\n 2842 \n | \n\n Sat 5 Oct, \n Room 144 \n | \n
Dolutegravir
| \n Format \n | \n\n Abstract Title \n | \n\n Author / \nPresenter \n | \n\n Abstract / \nPoster Number \n | \n\n Time (ET) / Location \n | \n
| \n Poster \n | \n\n Risk of Type 2 Diabetes Mellitus after Antiretroviral Therapy Initiation in Individuals Living with HIV in the United States \n | \n\n Ricky Hsu \n | \n\n 341 \n | \n\n Thurs 3 Oct, \n Hall B + C \n | \n
| \n Oral \n | \n\n Changes in BMI Associated with Antiretroviral Regimens in Treatment-Experienced, Virologically Suppressed Individuals Living with HIV \n | \n\n Karam Mounzer \n | \n\n 978 \n | \n\n Fri 4 Oct, \n Room 206 \n | \n
| \n Poster \n | \n\n Virologic Failure In ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir Based Regimen \n | \n\n Michael Wohlfeiler \n | \n\n 2488 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
Juluca (dolutegravir/rilpivirine)
| \n Format \n | \n\n Abstract Title \n | \n\n Author / \nPresenter \n | \n\n Abstract / \nPoster Number \n | \n\n Time (ET) / Location \n | \n
| \n Poster \n | \n\n SWORD 1&2: Switch from TDF Containing Regimen to DTG+RPV Maintains Bone Mineral Density and Decreases Bone Turnover Markers Over 148 Weeks \n | \n\n Lesley Kahl \n | \n\n 319 \n | \n\n Thurs 3 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Characteristics and Outcomes Over First 12 Months of a Two-Drug Regimen (Dolutegravir/Rilpivirine) for Treatment of HIV-1 in the United States \n | \n\n Gerald Pierone \n | \n\n 2483 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Patient Reported Outcomes After Switching to a 2-Drug Regimen of Dolutegravir + Rilpivirine: Week 148 Results from the Sword-1 and Sword-2 Studies \n | \n\n Alan Oglesby \n | \n\n 2484 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Real World Experience with Dolutegravir Plus Rilpivirine Two-Drug Regimen \n | \n\n Douglas Ward \n | \n\n 2485 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
Fostemsavir
| \n Format \n | \n\n Abstract Title \n | \n\n Author / \nPresenter \n | \n\n Abstract / \nPoster Number \n | \n\n Time (ET) / Location \n | \n
| \n Poster \n | \n\n Fostemsavir drug-drug interaction profile, an attachment inhibitor and oral prodrug of temsavir, for heavily treatment experienced HIV-1 infected patients \n | \n\n Katy Moore \n | \n\n 2500 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Systematic Literature Review of Multiclass Resistance in Heavily Treatment Experienced Persons with HIV \n | \n\n Julie Priest \n | \n\n 2510 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
Additional abstracts
| \n Format \n | \n\n Title of abstract \n | \n\n Author/ \nPresenter \n | \n\n Abstract/ \nPoster Number \n | \n\n Time (ET) / Location \n | \n
| \n Poster \n | \n\n Experiences and Emotional Challenges of Antiretroviral Treatment (ART) - Findings from the Positive Perspectives Study \n | \n\n Benjamin Young \n | \n\n 1329 \n | \n\n Fri 4 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Mental Health, Quality of Life, and Accessibility to Care Among Virally-Suppressed People Living with HIV in the United States \n | \n\n Tammeka Evans \n | \n\n 1257 \n | \n\n Fri Oct 4, \n Hall B + C \n | \n
| \n Poster \n | \n\n Decreasing Adherence to Antiretroviral Therapy over 4 Years of Follow-up in a Commercially-Insured Population of Patients with HIV \n | \n\n Julie Priest \n | \n\n 2512 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
| \n Poster \n | \n\n Qualitative Thematic Analysis of Social Media Data to Assess Perceptions of Daily Oral and Long-Acting Injectable Antiretroviral Treatment among People Living with HIV \n | \n\n Cindy Garris \n | \n\n 2496 \n | \n\n Sat 5 Oct, \n Hall B + C \n | \n
About cabotegravir
Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV. It is being evaluated as a long-acting formulation for intramuscular injection and also as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir prior to long-acting injection.
\nAbout rilpivirine long-acting
\nRilpivirine long-acting is an investigational, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is not approved by regulatory authorities anywhere in the world.
\nAbout Dovato (dolutegravir/lamivudine)
\nDovato is approved as a complete regimen for the treatment of HIV-1 infection in adults with no known antiretroviral treatment history and with no known substitutions associated with resistance to either dolutegravir or lamivudine. Dovato is a once-daily, single-tablet, two-drug regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50 mg) with the nucleoside analogue reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300 mg).
\nLike a DTG-based three-drug regimen, Dovato uses only two drugs to inhibit the viral cycle at two different sites. INSTIs, like dolutegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine is an NRTI that works by interfering with the conversion of viral RNA into DNA which in turn stops the virus from multiplying.
\nTrademarks are owned by or licensed to the ViiV Healthcare group of companies.
\nIMPORTANT SAFETY INFORMATION (ISI)
\nThe following ISI is based on the Highlights section of the Prescribing Information for Dovato. Please consult the full Prescribing Information for all the labeled safety information for Dovato.
\nWARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
\nDOSAGE AND ADMINISTRATION
\nCONTRAINDICATIONS
\nWARNINGS AND PRECAUTIONS
\nADVERSE REACTIONS
\nThe most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, diarrhea, nausea, insomnia, and fatigue.
\nDRUG INTERACTIONS
\nUSE IN SPECIFIC POPULATIONS
\nPlease refer to the US Prescribing Information.
\nAbout Juluca (dolutegravir/rilpivirine)
\nJuluca is ViiV Healthcare’s first two-drug regimen (2DR), once-daily, single-pill that combines dolutegravir 50mg (ViiV Healthcare), the most widely prescribed integrase inhibitor (INI) worldwide, with the nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine 25mg (Janssen Sciences Ireland UC). Juluca was granted marketing authorisation by regulatory authorities in the United States in November 2017, the European Union and Canada in May 2018, and Australia in June 2018.[9],[10],[11],[12] ViiV Healthcare has also submitted regulatory marketing applications in other countries worldwide.
\nJuluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any NNRTI or INI.9
\nTwo essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells.
\nU.S. IMPORTANT SAFETY INFORMATION: JULUCA (dolutegravir and rilpivirine) tablets
\nProfessional Indication(s) and Important Safety Information
\nIndication and Usage for JULUCA
\nJULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
\nImportant Safety Information
\nCONTRAINDICATIONS
\nJULUCA is contraindicated in patients:
\nWARNINGS AND PRECAUTIONS
\nSkin and Hypersensitivity Reactions:
\nHepatotoxicity:
\nDepressive Disorders:
\nRisk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
\nADVERSE REACTIONS: Most common adverse reactions with JULUCA (incidence ≥2%, all Grades) were diarrhea (2%) and headache (2%).
\nDRUG INTERACTIONS
\nUSE IN SPECIFIC POPULATIONS
\nDOSAGE AND ADMINISTRATION
\nFull US prescribing information is available at:
\n\nFor the EU Summary of Product Characteristics, please visit:
\nhttps://www.medicines.org.uk/emc/product/9246
\nAbout fostemsavir
\nFostemsavir is an investigational prodrug of temsavir, an HIV-1 attachment inhibitor class, and is not authorised by regulatory authorities anywhere in the world. Fostemsavir is being developed by ViiV Healthcare for the treatment of HIV-1-infected heavily treatment-experienced patients in combination with other antiretroviral agents.
\nAbout ViiV Healthcare
\nViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
\nFor more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
\nAbout GSK
\nGSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
\nReferences
\n[1] Margolis DA, Sutton KC, De Vente D, et al. Long term efficacy, safety and durability of CAB and RPV as two drug oral maintenance therapy – LATTE Week 312 results. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[2] Teichner P, Cutrell A, D'Amico R, et al. Patient adherence to long-acting cabotegravir + rilpivirine through 48 weeks of maintenance therapy in the Phase 3 ATLAS and FLAIR studies. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[3] Garris C, Heidenreich S, Arthurs E, et al. Perceptions of and preferences for oral or long-acting injectable antiretroviral treatment regimens in the United States and Canada. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[4] Mantsios A, Murray M, Karver TS, et al. CARLA Women Women’s perspectives on and experiences with long-acting injectable anti-retroviral therapy in the United States and Spain: the potential role of gender in patient preferences. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[5] van Wyk J, Man C, Sievers J, et al. Durable efficacy of two-drug regimen (2dr) of dolutegravir (dtg) plus lamivudine (3tc) in antiretroviral treatment-naïve adults with hiv-1 infection at 96 weeks: subgroup analyses in the GEMINI studies. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[6] Oglesby A, Angelis K, Punekar Y, et al. Juluca SWORD PROs data. Patient reported outcomes after switching to a 2-drug regimen of dolutegravir + rilpivirine: Week 148 results from the SWORD-1 and SWORD-2 studies. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[7] Young B, Marcotullio S, Punekar Y, et al. Experiences and emotional challenges of antiretroviral treatment (ART) - findings from the positive perspectives study. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[8] Evans TM, Cutts KN, Swinburn P, et al. Mental health, quality of life, and accessibility to care among virally-suppressed people living with HIV in the United States. Planned presentation at the Infectious Disease Society of America (IDSA) IDWeek™ 2019, 2-6 October, Washington, DC.
\n[9] Juluca EU Summary of Product Characteristics www.ema.europa.eu.
\n[10] Juluca (dolutegravir and rilpivirine) Prescribing Information. U.S Approval 2017.
\n[11] Health Canada. Juluca certified product information document. 18 May 2018.
\n[12] Australian Government. Department of Health Therapeutic Goods Administration. Juluca Product Information - ARTG ID 291356. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-01956-1&d=2018062916114622483 Last accessed September 2019.
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