Innovative regulatory strategy drastically reduces time needed for new HIV drug to reach children

HIV remains a significant health issue among children, with almost two million children living with HIV, mostly in low- and middle-income countries. Of these children, the treatment they need to survive.

In many low- and middle-income countries, people living with HIV are treated with more affordable generic versions of brand-name medications, provided through national treatment programs in the public health system.

However, children have historically been left behind adults when a new optimal generic medicine is developed and registered. They often wait decades until effective, age-appropriate formulations of the same medications become available.

Since 2016, Unitaid has funded the Clinton Health Access Initiative through its Optimal grant to bring the best HIV medications for adults and children to market more quickly and integrate them into treatment programs in communities that need them most.

In 2020, we partnered with ViiV Healthcare and two generic manufacturers to transform the process for getting a new generic HIV drug to market, called pediatric dolutegravir (DTG). What usually takes years, if not decades, was achieved in under two years.

Highlights:

• A novel regulatory strategy and public-private partnership led to the fastest-ever approval of a generic HIV medication for children, proving delays in access to lifesaving commodities do not have to be the status quo.
• In just under a year after regulatory approval, the generic medication began rolling out, with the HIV drug on order or delivered to over 70 countries to date.
• Negotiating an affordable and sustainable price in advance of the product launch resulted in a 75 percent reduction from the existing standard of care, bringing the total annual cost for a full regimen to treat pediatric HIV, which includes DTG, down from US$480 to US$120.

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