ViiV Healthcare gets European Marketing Authorization for children’s HIV drug

UNITED KINGDOM— ViiV Healthcare has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommending the marketing authorization of Triumeq PD, their HIV treatment for children.

Triumeq PD is a once-daily dispersible tablet formulation of a fixed dose of abacavir, dolutegravir, and lamivudine, and is the first dispersible single tablet regimen with dolutegravir.

According to ViiV Healthcare, the approval provides access to age-appropriate formulations of dolutegravir for a younger population and helps to close the gap between HIV treatment options available for adults and children living with HIV.

The FDA had already approved Triumeq PD in March 2022 for pediatric HIV-1 patients weighing 10-25 kg, while the minimum weight for a child to be prescribed the drug in Europe was previously 40 kg.

However, this will be lowered to 25 kg with the CHMP’s positive opinion.

ViiV Healthcare is a global HIV specialist company, majority-owned by GlaxoSmithKline (GSK), with other shareholders being Pfizer Inc. and Shionogi Limited.

ViiV Healthcare considered the authorization to be an important step towards meeting its commitment to bringing pediatric formulations to children living with HIV.

In 2021, only 52% of children under 14 years living with HIV had access to optimized pediatric formulations of antiretrovirals, despite significant advances in HIV treatment and care.

The company’s CEO, Deborah Waterhouse, expressed the company’s commitment to developing medicines that address the unmet needs of the estimated 1.7 million children living with HIV.

“Around the world today, an estimated 1.7 million children are currently living with HIV,” Waterhouse said.

She added that it is unfortunate as data from UNAIDS suggest only 52% of children living with HIV are on antiretroviral therapy (ART), which falls far behind the 76% of adults receiving ART.

Meanwhile, the quest to develop an HIV vaccine has suffered a major setback with the failure of the “last true candidate in development” to prevent infections in late-stage clinical trials.

Despite decades of research, only one vaccine candidate has shown marginal efficacy in preventing HIV infections, completed in the early 2000s.

Over the past few decades, there have been a total of nine late-stage clinical trials for HIV vaccines, including Mosaico and Imbokodo, with one ongoing trial in Africa called PrEPVacc.

However, the vaccine being tested in PrEPVacc is not expected to be approved for licensure even if it proves to be effective.

The multinational Mosaico study, which began in 2019 and involved over 3,900 volunteers, was testing a four-shot HIV vaccine for cisgender men and transgender people who have sex with cisgender men and/or transgender people.

The trial was stopped after a planned data review by the study’s independent data and safety monitoring board found the vaccine was safe but ineffective.

Researchers were hoping to improve on those results by investigating vaccines based on ‘mosaic’ immunogens, snippets of genetic material from multiple HIV subtypes, designed to train the body’s immune system to recognize the wide array of global HIV strains.

However, HIV is notorious for mutating quickly and shielding itself from being recognized by antibodies with a heavily sugared protein coat, making vaccine development challenging.

Globally, an estimated 38.4 million people were living with HIV in 2021, according to the Joint United Nations Programme on HIV/AIDS.

Some 1.5 million people currently contract the virus annually, a figure that has more than halved since its peak in 1996.

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