Juluca® (Dolutegravir and Rilpivirine) Approved in US as First 2-drug Regimen, Once-daily, Single Pill – a Complete Regimen for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection

Juluca® (Dolutegravir and Rilpivirine) Approved in US as First 2-drug Regimen, Once-daily, Single Pill – a Complete Regimen for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection

Canada NewsWire

LONDON, Nov. 22, 2017 /CNW/ - ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.[1]

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Juluca is the first 2-drug regimen (2DR) comprising dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor.

Deborah Waterhouse, CEO ViiV Healthcare said, “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.  This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-1[2] and SWORD-2,[2] which showed the 2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (CAR 485/511 [95%], dolutegravir + rilpivirine 486/513 [95%] [adjusted difference -0.2% (95% confidence interval CI: 3.0%, 2.5%), pooled analysis]).[2] Virologic suppression rates were similar between treatment arms.[2]    Drug related adverse events and adverse events leading to withdrawal occurred in low frequencies in both arms of the study, but more frequently in the investigational arm. 

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir. Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”

Juluca is the first medicine in our 2-drug regimen pipeline, which looks to help lessen the lifetime burden of treatment for people living with HIV.  Our R&D efforts are exploring the potential of two further 2-drug regimens both in phase III development, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, as well as cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients.

Notes to editors

In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HiV.

About HIV 

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.

HIV has largely become a chronic treatable disease, with improved access to antiretroviral treatment leading to a 22% drop in global HIV mortality between 2009 and 2013,[3] but more can be done for the estimated 36.7 million people living with HIV and 1.8 million individuals newly infected each year worldwide.[4]

About Juluca 

Juluca is a 2-drug regimen, once-daily, single pill that combines the INSTI dolutegravir (50mg), with the NNRTI rilpivirine (25mg) taken once-daily as a complete HIV regimen for people living with HIV who are virologically suppressed.  

Two 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 INSTIs 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.

Juluca was approved by the US Food and Drug Administration (FDA) on 21st November 2017, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. Juluca is expected to be available in pharmacies in the US from 11th December 2017.

ViiV Healthcare has also submitted regulatory marketing applications in Europe, Canada, Australia and Switzerland.

About the SWORD phase III program for dolutegravir (Tivicay®) and rilpivirine (Edurant®) 

The SWORD phase III program evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy (full 148-week data will be shared in 2018). In the SWORD clinical trials, dolutegravir and rilpivirine are provided as individual tablets.

The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch and adherence to treatment regimens.

For more information on the trials please visit: http://www.clinicaltrials.gov

Juluca and Tivicay are registered trademarks of the ViiV Healthcare group of companies.

*Edurant is a registered trademark of Janssen Sciences Ireland UC.

HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA.

JULUCA (dolutegravir and rilpivirine) tablets, for oral use Initial U.S. Approval: 2017

INDICATIONS AND USAGE 

JULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.

DOSAGE AND ADMINISTRATION 

  • One tablet taken orally once daily with a meal.
  • Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration.

DOSAGE FORMS AND STRENGTHS 

Each tablet contains: 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride).

CONTRAINDICATIONS 

  • Previous hypersensitivity reaction to dolutegravir or rilpivirine.
  • Coadministration with dofetilide.
  • Coadministration with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response.

WARNINGS AND PRECAUTIONS 

  • Severe skin and hypersensitivity reactions characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
  • Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended.
  • Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms.

ADVERSE REACTIONS 

The most common adverse reactions (all Grades) observed in at least 2% of subjects were diarrhoea and headache.

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-888-844-8872 or FDA at 1-800-FDA-1088 or

http://www.fda.gov/medwatch

.

DRUG INTERACTIONS 

  • Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • Refer to the full prescribing information for important drug interactions with JULUCA.
  • Drugs that induce or inhibit CYP3A4 or UGT1A1 may affect the plasma concentrations of the components of JULUCA.
  • Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA
  • Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes.

USE IN SPECIFIC POPULATIONS 

  • Lactation: Breastfeeding is not recommended due to the potential for HIV transmission.

About ViiV Healthcare 

ViiV 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.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com.

About GSK  

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

References 

  1. Juluca US label information
  2. Llibre JM, Hung C-C, Brinson C, et al. SWORD 1 & 2: Switch to DTG + RPV maintains virologic suppression through 48 weeks, a Phase III study. Presented at: Conference on Retroviruses and Opportunistic Infections; February 13-16, 2017; Seattle, WA, USA.
  3. World Health Organization. Global Update on the health sector response to HIV, 2014. July 2014. Available at: http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1. Last accessed November 2017.
  4. World Health Organization. HIV/AIDS Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs360/en/. Last accessed November 2017.

SOURCE ViiV Healthcare

View original content: http://www.newswire.ca/en/releases/archive/November2017/21/c7379.html

The Canadian Centre on Substance Use and Addiction Welcomes Glenn Brimacombe as Vice-president

The Canadian Centre on Substance Use and Addiction Welcomes Glenn Brimacombe as Vice-president

Canada NewsWire

OTTAWA, Nov. 21, 2017 /CNW/ - The Canadian Centre on Substance Use and Addiction (CCSA) is pleased to announce the appointment of Mr. Glenn Brimacombe to Vice-president, Strategic Partnerships and Priorities, a new executive leadership role within the organization. Mr. Brimacombe will officially assume this position on January 8, 2018.

Mr. Brimacombe comes to CCSA from the Canadian Psychiatric Association (CPA), where he was Chief Executive Officer. Previously, he was President and Chief Executive Officer for the Association of Canadian Academic Healthcare Organizations, now known as HealthCareCAN.

“I am delighted to welcome Glenn to the CCSA team as our new vice-president of Strategic Partnerships and Priorities,” said Rita Notarandrea, CEO of CCSA. “The issues surrounding substance use and addiction are complex and consequential. To address them requires an approach that involves having everyone at the table. For nearly three decades, Glenn has cultivated these kinds of strategic partnerships in the healthcare sector and I am so pleased that we will soon bring his talent and expertise to CCSA and to the individuals and organizations we serve.”

For thirty years, CCSA has been at the forefront of knowledge mobilization, bridging the gap and connecting the dots between people, issues and resources across Canada on matters of substance use and addiction. As the only pan-Canadian health organization with a mandate to explore the effects of both licit and illicit substances on the health and safety of Canadians, CCSA has built a strong reputation and an even stronger network of stakeholders with a common goal of reducing the harms of substance use on Canadian society and the economy.

Mr. Brimacombe is uniquely positioned to assume this new role and advance this important work. Throughout his career, his focus has been on the management of strategic policy issues related to the organization, financing and delivery of healthcare, and the federal role in research, innovation and commercialization, as well as the identification, development and nurturing of a number of strategic alliances.

“I’m honoured to join a highly reputable national health agency that has an impressive track record in helping individuals and working with partners to achieve results on substance use and addiction,” said Mr. Brimacombe. “In my role as vice-president, and drawing on my past roles and experiences as a CEO of two national health organizations, I look forward to working in strategic partnership with a broad number of stakeholders to advance research, policy and practice on the services and supports to address substance use in Canada to the benefit of all Canadians.”

Mr. Brimacombe holds a master’s degree in economics from the University of Ottawa.

Previous Positions of Glenn Brimacombe

  • CEO, Canadian Psychiatric Association, 2013–2017
  • Co-chair, Health Action Lobby, 2009–2014
  • President and CEO, Association of Canadian Academic Healthcare Organizations, 2002–2013
  • Director, Health Programs, Conference Board of Canada, 2000–2001
  • Visiting Senior Policy Analyst, Health Canada, 1997–1998
  • Director, Health Economics, Canadian Medical Association, 1991–2000
  • Economist, Ontario Medical Association, 1988–1990
  • University of Ottawa, Master’s, Economics 1984–1988

About CCSA

CCSA is Canada’s only agency with a legislated national mandate to reduce the harms of alcohol and other drugs on Canadians. We do so by gathering the latest evidence and promoting that evidence widely. Created by an Act of Parliament in 1988, CCSA’s vision is for a healthier Canadian society where evidence transforms approaches to substance use. Our mission is to address issues of substance use by providing national leadership and harnessing the power of evidence to generate coordinated action to inform policy, practice and programs.

The Canadian Centre on Substance Use and Addiction changes lives by bringing people and knowledge together to reduce the harm of alcohol and other drugs on society. We partner with public, private and non-governmental organizations to improve the health and safety of Canadians.

CCSA activities and products are made possible through a financial contribution from Health Canada. The views of CCSA do not necessarily represent the views of the Government of Canada.

 

SOURCE Canadian Centre on Substance Use and Addiction

View original content: http://www.newswire.ca/en/releases/archive/November2017/21/c7000.html

William R. Jacyk, M.D., FRCPC is recognized by Continental Who’s Who

William R. Jacyk, M.D., FRCPC is recognized by Continental Who’s Who

PR Newswire

ELORA, Ontario, Nov. 21, 2017 /PRNewswire/ – William R. Jacyk, M.D., FRCPC is recognized by Continental Who’s Who as a 2017 Professional of the Year for his excellence in the Medical field. Dr. Jacyk’s professional title is Medical Director at GreeneStone Muskoka, which specializes in treating substance use disorders. He has amassed over 40 years of experience in treating addictions and conditions that often co-occur with substance abuse.

Prior to coming to Ontario, Dr. Jacyk served as an Associate Professor in Internal Medicine and Psychiatry at the University of Manitoba Teaching Hospital and St. Boniface General Hospital. He specialized in Substance Use Disorders in Health Professionals, Pilots, Air Traffic Controllers and First Responders, as well as in other safety-sensitive occupations. During his tenured 27 years at the university, he was co-investigator of ground-breaking research into the epidemiology and treatment of Substance Use Disorders in Seniors.  Upon his retirement, he joined Homewood Health Centre in 1999 with the express purpose of developing a residential program specifically for seniors, and was subsequently instrumental in developing a comprehensive program for those who suffered concurrently from addiction as well as post-traumatic stress disorder.

Twelve years later, Dr. Jacyk joined the team at GreeneStone – where he is considered the Senior Clinical Consultant – to develop an evidence-based concurrent disorders program in a healing environment.

In addition to his work in practice as well as in the classroom, Dr. Jacyk published research identifying the issues of alcohol and prescription drug abuse in the elderly community.

Dr. Jacyk earned his Medical degree from the University of Manitoba. He then went on to complete his internship as well as his residency at Saint Boniface Hospital, where he served as chief resident.

To further his professional development, Dr. Jacyk served as the Chairman of the Canadian Center for Abuse Awareness; is a Fellow of the Royal College of Physicians and Surgeons; has been named to Leading Physicians of the World; serves as the National Coordinator for Treatment and Education for NavCanada; and is a Member of the Canadian Society of Addiction Medicine.

In recognition of his outstanding accomplishments in the field, Dr. Jacyk was awarded the Queens Jubilee Medal in 2002.

When not working, Dr. Jacyk enjoys playing golf, gardening and spending time with family. He dedicates this recognition to his 13 grandchildren.

For more information, visit www.greenestone.net.

Contact: Katherine Green, 516-825-5634, pr@continentalwhoswho.com

 

View original content:http://www.prnewswire.com/news-releases/william-r-jacyk-md-frcpc-is-recognized-by-continental-whos-who-300560662.html

SOURCE Continental Who’s Who