GSK releases positive interim results from the DAWNING study on efficacy of dolutegravir (Tivicay)
18 August 2017
ViiV Healthcare1, a joint venture in which GSK is the majority shareholder, released the interim results from the DAWNING study2 at the recent International AIDS Conference. The study shows that for HIV-infected patients, the antiviral efficacy of the regimen of dolutegravir (Tivicay3) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) is superior to that of the lopinavir/ritonavir + 2 NRTIs regimen currently recommended by WHO.
As of the end of June 2016, there are about 56,000 people living with HIV in China receiving the lopinavir/ritonavir + 2 NRTIs treatment. DAWNING shows that the regimen of dolutegravir (Tivicay), which has been launched in China, plus 2 NRTIs, is more efficacious than the current standard of care.
DAWNING is a multinational clinical trial, with four Chinese hospitals located in Beijing, Shanghai and Guangzhou participating in it. Data from the study includes clinical research data on Chinese people living with HIV and research data contributed by clinical doctors in China.
The already published SINGLE study shows that the regimen of dolutegravir (Tivicay) + 2 NRTIs (abacavir and lamivudine) has significantly higher efficacy and better tolerance than the first line regimen of efavirine +2 NRTIs (tenofovir+ emtricitabine).
Interviewed at the International AIDS Conference, Professor Fujie Zhang from Beijing Ditan Hospital of Captical Medical University, DAWNING’s primary investigator in China, said: “DAWNING is a milestone multinational clinical trial. At present, the recommended second line regimen in both developed and developing countries is still protease inhibitor plus booster +2 NRTIs. DAWNING shows that in terms of efficacy and tolerance, the protease inhibitor-sparing regimen of dolutegravir + 2 NRTIs is superior to the regimen of lopinavir/ritonavir + 2 NRTIs currently recommended by WHO. I am glad that a better second line regimen is now available to people living with HIV. ”
Professor Fujie Zhang also said: “Integrase inhibitors such as dolutegravir offer high efficacy, good tolerance, zero resistance, convenience and less drug drug interation (DDI), thus better meeting the varied treatment needs of doctors and people living with HIV. HIV treatment is entering an era of integrase inhibitors such as dolutegravir, so I hope that integrase inhibitors will become the agent of choice for not only second line but alsofirst line regimen in China.”
Dr. Wim Swyzen, VP & Country Medical Director for GSK China and Hong Kong, said: “Results from both DAWNING and SINGLE studies prove that the new regimen with dolutegravir (Tivicay) as core agent has superior efficacy to the first and second line regimens currently in place in China. The studies have also reaffirmed the important ?position of dolutegravir (Tivicay) in HIV treatment. GSK is working with relevant Chinese authorities to increase the access & affordabilty of Tivicay to benefit more Chinese people living with HIV in the near future.”
As part of the ‘in China, with China, for China’ strategy, GSK China has:
- Announced partnership with Ali Health to launch innovative online service platform to improve adult vaccination consultation experience in Aug 2017.
- Announced innovative antiretroviral?Single Tablet Regimen Triumeq received approval in China in Aug 2017.
- Announced Cervarix, first vaccine for cervical cancer prevention in mainland China, was officially launched in July 2017.
- Announced the collaboration programme to aid hepatitis prevention and treatment in poverty-stricken areas of the western region in July 2017.
- Announced Seroxat CR and Tykerb on the list of reimbursed drugs as results of the national health insurance negotiations in July 2017.
- Announced a strategic partnership with academia to co-develop health big-data system and upgrade the management of respiratory diseases in June 2017.
- Aided the National Preventive Vaccination Services and Management Training Programme, helmed by the Chinese Preventive Medicine Association under the guidance of the National Health and Family Planning Commission, with the support of the China Centre for Disease Control and Prevention that officially kicked off in June 2017.
- Announced Viread, Arixtra, Requip and Mivacron included in the “2017 National Reimbursement Drug List” in Mar 2017.
- Joined hands with the Home of Red Ribbon to combat HIV/AIDS, unveiling plan to support people living with HIV in Nov 2016.
- Announced the strategic partnership with China Preventive Medicine Association (CPMA) to address major public health challenges in China in Nov 2016.
- Announced the approval of Cervarix in China to help protect women from cervical cancer in July 2016.
- Announced a Memorandum of Understanding between the GSK Institute for Infectious Diseases and Public Health and Tsinghua University to tackle global public health challenges in June 2016.
- Launched Tivicay, an innovative HIV drug, in June 2016.
- Participated in the national price negotiation pilot and announced a price reduction of our first line chronic hepatitis B treatment, Viread, by up to 67% in May 2016.
- Announced a Beijing-based Institute for Infectious Disease and Public Health to conduct local development programmes for pivotal HIV and TB R&D assets in March 2016.
- Partnered with the National Health and Family Planning Commission on a multi-year programme to fund independent training programmes in Hepatitis and COPD for over 13,000 healthcare professionals from September 2015.
- Formalised a partnership with Shanghai-based Desano Pharmaceuticals to locally manufacture the Active Pharmaceutical Ingredient for Tivicay (dolutegravir) in July 2015.
- Transformed our commercial operating model to actively contribute to improving the quality of scientific exchanges with healthcare professionals for the benefit of patients since May 2015.
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 www.gsk.com.
GSK commitment to China
We are a science-led global healthcare company. We research, develop and manufacture a wide range of medicines, vaccines and consumer healthcare products. People are at the heart of what we do. We strive to bring high quality, high performing products to everyone who needs them. Creating innovative products and improving access to them is critical to our mission, allowing us to help build stronger, healthier communities. In China, and around the world, we are on a mission to help people do more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.
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1. ViiV Healthcare, a joint venture in which GSK is the majority shareholder, is a global specialist HIV company.
2. DAWNING is a phase IIIb, non-inferiority study conducted to compare a protease inhibitor-sparing regimen of DTG and 2 NRTIs with a current WHO-recommended regimen of LPV/RTV + 2 NRTIs in HIV-1 infected patients failing first-line therapy of a NNRTI + 2 NRTIs (ClinicalTrials.gov: NCT02227238). The IDMC performed periodic reviews of data to protect the ethical and safety interests of patients.
3. Tivicay (dolutegravir), an innovative HIV drug from ViiV Healthcare, is for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.
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 2016.