·  Legal News, Analysis, & Commentary

Drugs & Medical Devices

GSK Makes Easier to Swallow HIV Drug for Children

— December 25, 2019

GSK ViiV’s new HIV drug will be easier for children to swallow.

According to the United Nations agency UNAIDS, approximately 1.7 million children have HIV, most of them in sub-Saharan Africa.  British drug maker GlaxoSmithKline (GSK)’s ViiV has applied for a license to market its HIV drug ‘dolutegravir’ in a new formulation that will be easier for infants and children to swallow, and if approved by regulators, dolutegravir will be the first new generation baby-friendly HIV medicine available.

Thus far, physicians treating children infected with the virus have had to prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects, because there has not been a proper formulation for dolutegravir.

“Children in today’s world, still have fewer options in terms of HIV therapies compared to adults,” said Harmony Garges, chief medical officer for ViiV Healthcare, GSK’s HIV drugs division.  She said she hoped “the license application would enable approval of dolutegravir across the pediatric spectrum.”

GSK Makes Easier to Swallow HIV Drug for Children
Photo by Annie Spratt on Unsplash

GSK ViiV’s CEO Deborah Waterhouse added, “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.”

Dolutegravir is an integrase inhibitor originally developed by GSK ViiV.  WebMD says, “It helps to decrease the amount of HIV in your body so your immune system can work better.  This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.”

The Centers for Disease Control and Prevention (CDC) indicates, “Pregnant women with HIV may not know they have the virus.  CDC recommends HIV testing for all women as part of routine prenatal care.  According to CDC research, more women take the prenatal HIV test if the opt-out approach is used.  Opt-out prenatal HIV testing means that a pregnant woman is told she will be given an HIV test as part of routine prenatal care unless she opts out – that is, chooses not to have the test. In some parts of the country where HIV among women is more common, CDC recommends a second test during the third trimester of pregnancy.”

The agency adds, “For babies with HIV, starting treatment early is important because the disease can progress more quickly in children than adults.  Providing HIV medicine early can help children with perinatal HIV live longer, healthier lives.”  Thankfully, new HIV infections among children have fallen by 41% since 2010.  However, according to the CDC, there were 160,000 new cases in babies and children in 2018 and 100,000 children still died of AIDS that same year.

Helen McDowell, ViiV’s head of government affairs and global public health, said, “Subject to licenses being granted by U.S. and European drug regulators,” the company will plan for an initial roll-out in sub-Saharan Africa in 2020.  ViiV’s child formulation will be priced at “cost of production,” she said.

“ViiV is planning licensing agreements with two generic drugmakers, Mylan Laboratories and Macleods Pharmaceuticals, who aim to make cheaper generic versions of the dispersible pill available within months of ViiV’s coming to market,” McDowell added.


GSK’s ViiV seeks marketing licence for baby-friendly HIV pill

GSK’s ViiV seeks marketing license for baby-friendly HIV pill

WebMD: Dolutegravir Tablet

HIV and Pregnant Women, Infants, and Children

Join the conversation!