FDA OKs ViiV Healthcare's HIV Medication For Infants And Children

(RTTNews) - Pharmaceutical company ViiV Healthcare Ltd. said the U.S. Food and Drug Administration (FDA) approved its Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for oral suspension to treat human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients at least four weeks old and weighing at least 3 kg or 6.61 pounds in combination with other antiretroviral treatments.

ViiV Healthcare is a global specialist HIV company majority-owned by GlaxoSmithKline plc. or GSK, with Pfizer Inc. and Shionogi Limited as shareholders. Tivicay is marketed in the US by ViiV Healthcare and manufactured by GSK.

The already approved Tivicay (dolutegravir) 50mg film-coated tablet is now approved for extended indication to expand the use in paediatric HIV patients weighing 20kg and above. It was previously approved in August 2013 for adults and children aged 12 years and older and weighing at least 40 kg.

In 2016, the FDA approved a reduction in the weight limit from at least 40kg to at least 30kg for the treatment of HIV with Tivicay for children and adolescents aged 6 to 12 years old.

Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for infants. This makes it easier for young children to take this medication by dispersing the tablet in water.

HIV is a lentivirus that delivers a significant amount of genetic information into the DNA of the host cell. The drug blocks HIV replication by averting the viral DNA from assimilating into the genetic material of human immune cells (T-cells).

HIV is responsible for causing acquired immune deficiency syndrome (AIDS), a fatal disease that destroys the immune system if not treated. It is categorised into two types, HIV-1 and HIV-2. HIV-1 is more virulent and infective than HIV-2.

Tivicay and Tivicay PD are intended to treat pediatric patients at least 4 weeks old and 3 kg who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor (INSTI) class drug. This approval will now help provide an age-appropriate formulation to a younger population.

Latest statistics show that there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life. Children continue to be affected by mother-to-child transmission.