First ever HIV generic drug for babies distributed in Africa, says UNITAID

AFRICA – UNITAID and Clinton Health Access Initiative (CHAI) funding has enabled procurement of 100,000 packs of the dolutegravir formulation, a strawberry-flavored tablet for children living with HIV in six African countries.

These aid agencies have distributed the first generic pediatric version of a key anti-retroviral, global across Nigeria, Malawi, Uganda, Kenya, Zimbabwe and Benin, UNITAD’s spokesman Herve Verhoosel said in statement.

UNITAID and CHAI had reached a pricing agreement with the generic drug makers Viatris and Macleods for the dispersible pediatric formulation of dolutegravir.

The first-line HIV treatment is recommended by the World Health Organization from the age of four weeks and 3 kilos (6.6 pounds), but it had been out of reach for babies because of the lack of appropriate formulations.

There are 1.8 million children worldwide living with HIV, but only half receive any treatment, often hard to administer due to the bitter taste or incorrectly dosed by crushing adult pills. An estimated 100,000 children die of AIDS annually.

The estimated cost for combination therapy will now be some $120 for a child’s annual treatment, against $480 currently, making it a “game-changer” for poorer countries, UNITAID said.

HIV as an infection continues to be a major global public health issue, having claimed 34.7 million (26.0–45.8 million) lives so far.

So far, the disease has no cure but due to technological advancements, it is now a manageable condition.

Yesterday, US Food & Drug Association (USFDA) granted approval for the marketing of generic Emtricitabine and Tenofovir Disoproxil Fumarate tablets used for treatment of HIV infection.

Zydus Cadila, a drug manufacturing company based in India, said the drugs are to be used alongside other medications to help control HIV infections to decrease the amount of HIV in one’s body so that the immune system can work better.

Just in 2020, an estimate of 37.6 million people are said to be living with HIV and two thirds come from Africa according to the WHO, among which 1.9 million are children with more than 60% of all new HIV infections occurring in women, infants, or young children.

Currently, the global HIV drugs market is expected to grow from $30.52 billion in 2020 to $31.28 billion in 2021 at a compound annual growth rate (CAGR) of 2.5%.

This change in growth trend is mainly due to the companies stabilizing their output after catering to the demand that grew exponentially during the COVID-19 pandemic in 2020 and the market is expected to reach $36.46 billion in 2025 at a CAGR of 3.9%.

The distribution of this infant formulation will bolster the activities being undertaken by WHO and Global Fund in trying to scale up mitigation efforts against HIV/AIDS in Africa.

The two recently signed a cooperation and financing agreement to implement strategic initiatives towards accelerating the end of AIDS in African nations.

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