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Azerbaijan and Belarus have received MPP-licensed dolutegravir(Source:Alamy)

The first shipments of dolutegravir to two upper-middle-income countries, Azerbaijan and Belarus, under a licensing deal agreed by the Medicines Patent Pool have been announced by the MPP.

Last November, the MPP and ViiV Healthcare signed a new voluntary licensing agreement to enable greater access for dolutegravir-based regimens in certain upper-middle-income countries. (MPP Gives 18 December Deadline For Dolutegravir Sublicense Applications)

Licensees subsequently selected by the MPP in April 2021 to supply dolutegravir-based treatment regimens for HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia included Viatris’ Mylan and Hetero Drugs. (Patent Pool Partners With Mylan And Hetero On Dolutegravir)

MPP executive director Charles Gore said at the time that the organization was “delighted that more people living with HIV in the four countries will soon be able to access dolutegravir-based regimens, especially TLD (tenofovir disoproxil fumarate/lamivudine/dolutegravir), the first-line regimen recommended by the World Health Organization, which will now be available in these countries in a single pill.”

The MPP said its licensing agreement with ViiV recognized “the specific challenges faced by these four upper-middle-income countries” and came “in response to feedback from the HIV community and the governments.”

Announcing the shipments to Azerbaijan and Belarus, the MPP also revealed that “the two other countries in the licence, Kazakhstan and Malaysia, are planning deliveries for early 2022.”

The licence for UMICs came in addition to adult and pediatric dolutegravir licences signed in 2014 covering the majority of low- and middle-income countries.

Shipments Came Just Three Months After Licenses Agreed

“Generic manufacturers, governments and procurement agencies were quick to respond to the new licence and to the needs of those waiting for dolutegravir in these countries,” said Gore. “In just three months after signing the sub-licence agreements with MPP, the first deliveries have arrived, which is remarkable.”

Insisting that “this important development will allow the Republics of Belarus and Azerbaijan to increase their citizens’ access to quality and evidence-based HIV treatment,” Valeria Grishechkina – fund portfolio manager for eastern Europe and central Asia at the Global Fund – said the move would “significantly contribute to the sustainability of HIV programs that have been supported by the Global Fund in these two countries for many years.”

“People living with HIV in Azerbaijan are delighted to start the transition to dolutegravir-based treatments,” emphasized Ramil Goyushov Vahid Oglu, chairman of Azerbaijan’s est-Resource Public Union on Civil Society Development Support, noting that this had been “only made possible because of increased access and affordable prices” that had allowed the country to expand its treatment coverage.

Meanwhile, Anatoliy Leshanok – deputy chairman of People PLUS in Belarus – said it was “great news” that the country had “just received the first batch of generic dolutegravir to treat 1,530 patients with HIV.”

“Many more patients will be able to be treated with the highly efficacious regimens with fewer to no side effects,” Leshanok stated. “We are looking forward to more and larger procurements and to increase affordability even further in order to provide all those in need with the treatments recommended by WHO.”

However, he said, “this is only the beginning of our country’s transition to dolutegravir. More will need to be done, including further price reductions. The HIV community stands ready to continue its collaboration with the Ministry of Health of Belarus, MPP, ViiV Healthcare and many other stakeholders to make it happen.”

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