Innovative HIV drug Tivicay approved for HIV-infected children ages 6-12

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GSK recently announced that Tivicay (Dolutegravir – DTG), an innovative HIV drug from ViiV Healthcare1(which is GSK’s holding JV) has been approved by the National Medical Product Administration (NMPA) for expanded indication and can now be used for treating HIV-infected children ages 6-12 in China. 

Tivicay was approved by the CFDA in December 2015 for treating HIV-infected adults and children ages 12 and above when used in combination with other antiretroviral drugs. The approval of Tivicay’s expanded indication presents more treatment options to HIV-infected children, thus benefiting the families of more HIV-infected patients in China. 

AIDS has remained a major health threat of the 21st century. An UNAIDS report shows that of the 36.9 million HIV-infected patients identified worldwide in 2017, 1.8 million were younger than 15 years old. 2 And a report by the Chinese Centre for Disease Control and Prevention shows the number of HIV-infected patients to be on a steady climb with more than 100,000 new patients added each year. 3

In WHO’s updated HIV/AIDS prevention and treatment guidelines in 2018, WHO recommends DTG as the first-line treatment option for HIV/AIDS in adults and adolescents.

The same guidelines point out that DTG is superior to non-DTG-based second-line treatment regimens (including for children, women of childbearing ages and pregnant women) and consequently recommend DTG as the second-line treatment option. The guidelines also recommend DTG + Tenofovir (TDF) + Lamivudine (3TC) or Emtricitabine (FTC) as the regimen for Post-Exposure Prophylaxis (PEP). 4

Tivicay has been approved in more than 100 countries and is recommended by most of the international treatment guidelines as the preferred first-line option combined with other antiretroviral treatment for HIV/AIDS infection.

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Professor Fujie Zhang from Beijing Ditan Hospital of Capital Medical University said: “In major international guidelines, the recommendation of drugs for HIV-infected children is less selective than that for adults. The combination of drugs is also less. Especially, HIV-infected children are at a special stage of growth, which requires higher requirements on the toxic and side effects of drugs that affect the success of treatment and the convenience of administration. There is an urgent need for high efficacy, safe and simple and convenient drugs to give children an option to obtain a higher quality growth environment. Integrase inhibitors represented by DTG have the advantages of high efficacy, good tolerance, non-resistance, simple and convenient administration and less drug interaction. The approval of DTG for treating HIV-infected children ages 6-12 is a significant milestone for the treatment of HIV in children.”


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“GSK has always been dedicated to developing highly effective antiviral drugs for treating HIV/AIDS on a global scale,” said Dr. James He, GSK China Vice President and Head of Medical Affairs. “As treatments advance, HIV-infected patients can live longer. Clinical data shows that Tivicay is effective and well-tolerated with a high resistance barrier. We believe that Tivicay will present a better treatment option to HIV-infected children and adults in China. At the same time, we will continue to work with the Chinese government on including Tivicay on the free ARV treatment list so that more HIV-infected patients in China can gain access to Tivicay.”


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1 ViiV Healthcare is a joint venture majority-owned by GSK and focusing on providing HIV-infected patients with advanced treatment and care.

2 UNAIDS: Global HIV & AIDS statistics - 2018 fact sheet

3 China’s Infectious Disease Prevention and Control System, Experience and Challenges (Liang Xiaofeng, Deputy Director of the Chinese Centre for Disease Control and Prevention)

4 WHO Interim Guidance: Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV