Kenya has become the first African country to introduce the generic version of the new first-line drug Dolutegravir (DTG) for people living with HIV.
Kenya and Unitaid (global health initiative working with partners to end world’s tuberculosis, HIV/Aids and malaria epidemic) announced the rollout of the drug, which has been in use in the past two years in high-income countries.
DTG has few side effects, is easier to ingest (one tablet daily), and patients are less likely to develop resistance.
In 2015, the WHO recommended Dolutegravir as an alternative first-line drug for adults and adolescents. But, until recently, people living with HIV in countries like Kenya were unable to access it.
A single pill will substitute either nevirapine or efavirenz singles, without increasing the pill burden. Additionally, patients can be easily transitioned to a triple fixed-dose combination once it becomes available.
“New regimens, including Dolutegravir, offer potential for better and less costly HIV treatment. Through this work, we are reducing the time it takes for people living with HIV in countries like Kenya to access the latest ARVs on the market.
"These are important developments as we move towards HIV treatment for all those that need it,” said Lelio Marmora, Unitaid executive director.
“This project will improve the lives of Kenyans living with HIV, build health care workers’ experience, and generate the evidence needed to introduce DTG on a larger scale by early next year,” said Jackson Kioko, director of medical services in Kenya’s Ministry of Health.
The ministry will initially provide DTG to 27,000 people living with HIV who are unable to tolerate the side effects of efavirenz, the first-line HIV drug currently in use in Kenya.
The new drug will be introduced in select health facilities across the country and made widely available nationwide later in the year.
Numerous phase 3 clinical trials have shown that DTG is superior to all other first-line treatments, and in 2016, Kenya included the drug in its antiretroviral therapy guidelines.
Nigeria and Uganda will introduce Dolutegravir later this year, laying the groundwork for accelerating uptake of the three-in-one fixed dose combination that will be made available by 2018.
Such combination, which will include tenofovir, lamivudine and DTG, is expected to simplify treatment for people living with HIV.
More than 18 million people are on lifelong HIV treatment worldwide, but an almost equal number do not have access to treatment yet. In Kenya, approximately 1.5 million people live with HIV, but just over one million are currently on ARVs.
Unitaid is investing $67 million to address this need in order to avoid delays of more than 10 years before new drugs can be introduced in low- and middle-income countries.
This intervention is also an opportunity to test Dolutegravir’s use in routine treatment for the first time and prepare national distribution channels.
“Unitaid is pioneering the introduction of simpler, more affordable optimal HIV treatments and ensuring they are available sooner for those in need, so countries and partners like the US President’s Emergency Plan for Aids Relief (Pepfar) and the Global Fund can bring them to scale,” said Mr Marmora.
WHO, partnering with the Global Fund, Pepfar, ministries of Health, civil society and the Clinton Health Access Initiative is expected to save $1.6 billion in treatment costs through 2024 – enough to provide access to medicines for an additional 3.2 million people for five years.
“This is the first step in ensuring access to better quality and more effective ARV therapy to improve the quality of life of people living with HIV,” said Kenly Sikwese, co-ordinator of the African Community Advisory Board.