TACOMA, Washington — In 2020, about 160,000 children were born infected with HIV. Despite decades-long campaigns and efforts to prevent mother-to-child transmission, the disease still claims the lives of more than 80,000 babies and toddlers annually. Among these, 90% of them live in sub-Saharan Africa. Alarmingly, treatment coverage among children living with HIV lags behind adults in most African countries with the largest HIV epidemics. In fact, coverage among children infected with HIV in 2019 was only 53%.
The Issue of Child-Friendly HIV Medicine
Inappropriate treatment options for children have contributed to this low coverage of HIV treatment and ultimately to the early deaths of thousands. A high share of these casualties is partly due to the difficulty in administering the medicine and its form not being child-friendly. The HIV medicines currently available come in the shape of hard pills or bitter syrups that are extremely difficult for toddlers to swallow.
For instance, ritonavir, probably the most common pediatric drug combination, contains a syrup that consists of “43% alcohol by volume.” It is characterized by a bitter metallic taste that remains for hours, which infants consequently avoid or simply do not tolerate. Since children infected with HIV usually need to take multiple medicines twice a day for the first four years of their life, the available methods just become unfeasible for many.
Quadrimune: New HIV Antiretroviral Treatment for Children
However, Cipla may have found the solution. Cipla, the leading global pharmaceutical company in India, announced in 2019 a new, improved pediatric formulation. The new drug, called Quadrimune, comes in strawberry-flavored granules in the size of grains of sugar. These granules are much easier to swallow. While Quadrimine still comes in capsules, parents can make it more palatable by mixing the medicine with milk or sprinkling it on baby cereal. What’s more, the capsules are first coated in a polymer that will not melt until it reaches the baby’s stomach, and then with a sweet flavoring. This makes it much more appetizing and pleasant for children.
Quadrimune includes the four WHO-recommended HIV drugs: abacavir, lamivudine, lopinavir and ritonavir, making it a “4-in-1” treatment. Furthermore, Quadrimune does not need refrigeration. Refrigeration is one of the main issues affecting most available medicines to date as they must be transported in cold, climatized trucks and then preserved in a refrigerator. This creates a problem particularly in sub-Saharan Africa where warm temperatures and inconsistent electricity are frequent. Also, families may not have access to a refrigerator, especially those living in rural areas. Hence, Quadrimune would eliminate this complicated need for cold storage that has hampered access to HIV medicines in the past.
This revolutionary drug will be offered at $1 a day for children between 20 to 30 pounds and only $0.50 per day for younger children. This makes it relatively affordable for families of all economic levels. In brief, this easy-to-take, heat-stable, inexpensive medicine promises to save thousands of children battling HIV. It will replace outdated, bitter-tasting formulations, medicines that require refrigeration and regimens no longer recommended by the WHO.
How It Was Made
Cipla developed Quadrimune in partnership with the not-for-profit Drugs for Neglected Diseases initiative (DNDi). Unitaid, among other donors, financially supported the initiative. It is also not the first time Cipla made global headlines. The company, which was founded in 1935, was the first generic drug company to offer HIV drugs in Africa. Cipla also transformed the provision of AIDS drugs almost 20 years ago, pricing them at $1 a day.
At the time, the giant pharmaceuticals and multinational drug companies were charging up to $150,000 for their treatments. Meanwhile, the company worked to block generic competitors such as Cipla from the market. Cipla was then the pioneer developer of pediatric fixed-dose combinations of antiretrovirals for children. After almost eight decades, the company proves that it is still capable of revolutionizing global health with ground-breaking medicines.
Unitaid, the organization behind the funding, supports initiatives that bring the power of new medical discoveries to those who need them the most. It also invests in innovation and research on new ways to prevent and diagnose diseases such as HIV more effectively and helps to set the stage for the large-scale launch of the latest health products. To accomplish its mission, Unitaid collaborates with important partners such as the Global Fund, the WHO and PEPFAR.
A Work in Progress, A Bright Future
Quadrimune is still under review by the U.S. Food and Drug Administration for use by children between 3kg and 25kg bodyweight. It was initially submitted for tentative approval in October 2019. Then, it was resubmitted for full approval in June 2020 to deal with a series of labeling issues. Unfortunately, the FDA was forced to delay the necessary inspections as a result of the ongoing COVID-19 pandemic. Nevertheless, the last project updates confirm that full U.S. FDA approval of the drug is now expected in the second half of 2021. Once approved, it would lead to rapid certification by WHO.
By any measure, Cipla’s Quadrumine will benefit thousands of young children whose proper HIV treatment has suffered neglect for so long. Until now, the lack of optimal antiretroviral drugs with an adequate pediatric format has stood in the way of ameliorating health outcomes for children living with HIV. So, if Quadrimune receives full approval this year, it will represent a major advancement in the treatment of the disease. The world has been eagerly waiting for a child-friendly HIV medicine. With Quadrimune, the wait has ended.
– Alejandra del Carmen Jimeno