ViiV Healthcare announces new strategic alliance to enable greater access to antiretroviral medicines in Brazil

Strategic alliance will enable local development and manufacture of a fixed dose combination of dolutegravir 50mg and lamivudine 300mg, with the aim of making this HIV treatment regimen more widely available to people living with HIV in Brazil

London, 15 July 2020 –ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as share holders, today announced a new partnership in Brazil with GSK, a science-led global healthcare company and the Institute of Technology in Pharmaceuticals (Farmaguinhos/ Fiocruz), aiming to enable increased access to antiretroviral treatments in Brazil.

The agreement includes the transfer of technology and "know-how" for the local manufacture of dolutegravir 50mg, which was registered in Brazil by ViiV Healthcare in 2014 and was introduced in the National Health System (SUS) in Brazil in 20161. GSK, ViiV Healthcare’s distributor to Brazil, currently supplies sufficient dolutegravir to the Brazilian Ministry of Health, enabling approximately 300,000 Brazilian people living with HIV to access this treatment. In the agreement, ViiV Healthcare will provide technical assistance for the development of lamivudine 300mg tablet, a drug that is already produced by Farmanguinhos in a 150mg dosage formulation.

ViiV Healthcare will also support Farmanguinhos to locally develop its own fixed dose combination of dolutegravir 50mg and lamivudine 300mg. The fixed dose combination of dolutegravir 50mg and lamivudine 300mg developed by ViiV Healthcare is currently under review by the Brazilian Healthcare Regulatory Agency (ANVISA). This is the first time that an antiretroviral treatment, not yet registered in Brazil, will be part of a strategic alliance between a global healthcare company and a Brazilian public laboratory.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “For the last 10 years we have worked closely with the Brazilian Ministry of Health to enable access to dolutegravir. Our hope is that this alliance will continue to build on that important work, supporting continued access to HIV medicines like dolutegravir 50mg and potentially enabling the fixed-dose combination of dolutegravir 50mg and lamivudine 300mg to be made available to more people living with HIV in Brazil. As part of our commitment to leave no person living with HIV behind, we are proud to join forces with one of Latin America’s most prominent science and health technology institutions to secure access to our innovative medicines, support the scientific community and boost local manufacturing capability in Brazil.”

The president of Fiocruz, Nísia Trindade, highlights the importance of this alliance to strengthen the National Health System (SUS). “This strategic alliance reaffirms Fiocruz's commitment to public health and to improving quality of life for people living in Brazil. Through this partnership, we will aim to modernise HIV treatment in Brazil and hopefully provide treatment options for thousands of people living with HIV in Brazil. At the same time, we will boost national science and production capability that is so important for the strengthening of our Public Health System," she points out.

In 2018, approximately 900,000 people in Brazil were living with HIV, 66% of whom were on treatment2 and over the past year, there were around 40,000 new HIV diagnoses in Brazil.3

As the only company 100% focused on people affected by HIV/AIDS, this partnership further reinforces our commitment to leaving no person living with HIV behind.

Notes to editors:

Please see the full US Prescribing Information, including Boxed Warning, for DOVATO

DOVATO (dolutegravir and lamivudine) tablets

DOVATO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO.

IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV,  additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:

  • Hypersensitivity reactions have been reported with dolutegravir and were characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
  • Discontinue DOVATO 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. 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 DOVATO. 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

Embryo Fetal Toxicity:

  • Alternative treatments to DOVATO 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 DOVATO and counsel that consistent use of effective contraception is recommended while using DOVATO in individuals of childbearing potential

Lactic Acidosis and Severe Hepatomegaly With Steatosis:
Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug Interactions). Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhoea (2%), insomnia (2%), and fatigue (2%).

DRUG INTERACTIONS

  • Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions
  • DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
  • Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir•
  • When coadministering DOVATO with carbamazepine or rifampin, take an additional TIVICAY (dolutegravir) 50-mg tablet, approximately 12 hours from the dose of DOVATO
  • Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. If planning a pregnancy or if pregnancy is confirmed while taking DOVATO during the first trimester, assess the risks and benefits of continuing DOVATO versus switching to another antiretroviral regimen. For individuals actively trying to become pregnant, initiation of DOVATO is not recommended unless there is no suitable alternative
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
  • Females and Males of Reproductive Potential: Perform pregnancy testing before initiation of DOVATO. Advise individuals of childbearing potential to consistently use effective contraception while taking DOVATO
  • Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <50 mL/min

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/about-us.

About Fiocruz
The Oswaldo Cruz Foundation (Fiocruz) is a scientific research and development institution linked to the Ministry of Health. It produces and disseminates knowledge and technologies aimed at strengthening and consolidating our health systems. The Foundation is the main research and development institution promoting public health in Latin America.

About The Institute of Pharmaceutical Technology (Farmanguinhos)
Farmanguinhos is the technical-scientific unit for Fiocruz (Oswaldo Cruz Foundation), which works in a multidisciplinary way in the areas of: education, research, technological innovation and drug production. As the largest official pharmaceutical laboratory linked to the Ministry of Health, the unit is more than a factory, it is an institute of science and technology in health. In addition to researching, developing and producing essential medicines for the Brazilian population, Farmanguinhos also stands out in the fight to reduce the costs of these products, allowing the expansion of more people to access public health programs.

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 "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

 

ViiV Healthcare Media enquiries:

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GSK Brazil media enquiries:

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GSK global media enquiries:

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Analyst / Investor enquiries:

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References

  1. https://viivhealthcare.com/en-gb/media/press-releases/2016/december/new-agreement-with-ministry-of-health-will-enable-access-to-dolutegravir-for-the-treatment-of-hiv-under-the-national-health-programme-in-brazil/
  2. UNAIDS. Country fact sheets –Brazil. https://www.unaids.org/en/regionscountries/countries/brazil. Accessed June 2020
  3. Brazil Ministry of Health –Basic HIV Clinical Monitoring Indicators and Data http://indicadoresclinicos.aids.gov.br/. Accessed June 2020