ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first five years of life.2 Major obstacles persist for children, such as the availability of HIV testing, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimized paediatric formulations of antiretrovirals.2,3

Deborah Waterhouse, CEO of ViiV Healthcare, said: “For parents living in resource poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death. By submitting these files to regulators for approval, we believe that we are on the cusp of delivering against our promise to develop dolutegravir in a tablet that can be dispersed simply in water. We will then aim to make this available, via partnerships, as quickly as possible to children living with HIV worldwide.”

These submissions to the EMA and FDA are based on data from the ongoing P10934 and ODYSSEY (PENTA20) studies.5 Data to support the submissions has been generated from ViiV Healthcare’s collaborations with the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and the Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY. 

Notes to editors:

About P1093 and ODYSSEY4,5

• P1093 (NCT03016533): investigates the safety, pharmacokinetic, tolerability and antiviral activity of DTG regimens in paediatric patients aged four weeks to 18 years and is being conducted by the IMPAACT network in the U.S., Brazil, Thailand, South Africa, Zimbabwe, and Malawi.
• ODYSSEY (PENTA20) (NCT02259127): is designed to understand how DTG as first- or second-line treatment compares to the current standards of care in paediatric patients aged four weeks to 18 years and is being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa. Originally designed to support the World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now provide data to support this submission. For more information, please visit the study website at: http://odysseytrial.org/

Important Safety Information
CONTRAINDICATIONS

• Do not use dolutegravir in patients with previous hypersensitivity reaction to dolutegravir
• Do not use dolutegravir in patients receiving dofetilide

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:

• Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
• Discontinue dolutegravir immediately if signs or symptoms of hypersensitivity reaction develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

• Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure) in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
• Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of dolutegravir. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
• Monitoring for hepatotoxicity is recommended

Embryofetal Toxicity:

• Alternative treatments to dolutegravir should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
• Perform pregnancy testing before use of dolutegravir and counsel that consistent use of effective contraception is recommended while using dolutegravir in adolescents and adults of childbearing potential 

Please see accompanying full Product Information for more details.
Full U.S. prescribing information is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Informatio n/Tivicay/pdf/TIVICAY-PI-PIL.PDF

For the EU Summary of Product Characteristics, please visit: https://www.ema.europa.eu/en/documents/product-information/tivicay-epar-product-information_en.pdf

About The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives and other partners organized for the purpose of evaluating interventions to treat and prevent HIV infection and its consequences in infants, children, adolescents and pregnant/postpartum women through the conduct of high-quality clinical trials.

The IMPAACT Network's research agenda includes evaluation of: new and existing anti-HIV drugs and formulations; novel approaches for addressing tuberculosis in HIV-infected or at-risk populations; biomedical/behavioral interventions to prevent mother-to-child HIV transmission; immunogenicity, safety and efficacy of high priority vaccines; potential for HIV cure through therapeutic interventions; and methods to prevent and manage complications and comorbidities of HIV infection and its treatment.

For more information on IMPAACT visit: https://impaactnetwork.org/

About PENTA
PENTA is a global independent scientific network dedicated to research in child health. Starting out from its work in HIV, today PENTA’s portfolio includes investigation into other infectious diseases affecting children, as well as infrastructure development initiatives and training programmes. Since 2012, PENTA has sponsored 35 clinical trials, with more than 5 million women and children enrolled into its studies. The work of PENTA is supported by a network of 110 clinical sites in 31 countries across the world whose expertise are leveraged to transform the prevention and treatment of infection in children.

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 www.viivhealthcare.com.

About GSK
GSK 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.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Principal risks and uncertainties’ in the company’s Annual Report on Form 20-F for 2018.