Kenya introduces generic version of first-line HIV drug

The Kenyan government is partnering with Unitaid to provide dolutegravir, a first-line drug, to people living with HIV, according to a press release.

Perspective from Elaine Abrams, MD

The effort makes Kenya the first African country to make the generic version of the drug — also known as Tivicay (ViiV Healthcare) — available for routine use.

“We are delighted to partner with Unitaid on this innovative project that will no doubt improve the lives of Kenyans living with HIV, build health care worker experience and generate the evidence needed to introduce dolutegravir on a larger scale by early 2018,” Jackson Kioko, MD, director of medical services for Kenya’s Ministry of Health, said in a news release.

For the past 2 years, dolutegravir has been preferred for treatment of HIV in high-income countries. It has few side effects, is taken once daily and is less prone to resistance than other drugs, according to the release.

In 2015, WHO recommended dolutegravir as an alternative first-line regimen to treat adults and adolescents, but it was inaccessible in low-income countries like Kenya. Now, the country’s Ministry of Health with provide it initially to 27,000 people with HIV who cannot tolerate the side effects of efavirenz, Kenya’s current first-line HIV drug, Unitaid said.

The agency added that dolutegravir will be available in certain health facilities throughout the country at first, and that officials hope to make it widely available later this year.

“New regimens including dolutegravir offer great potential for better and less costly HIV treatment,” Unitaid executive director Lelio Marmora said in the news release. “Through this catalytic work, we are significantly reducing the time it takes for people living with HIV in countries like Kenya to access the latest antiretrovirals on the market. These are important developments as we move toward HIV treatment for all in need.”

Nigeria and Uganda will introduce dolutegravir to their patients with HIV later this year, Unitaid said. The aim is to provide a fixed-dose combination including dolutegravir, tenofovir and lamivudine by 2018.

The efforts in all three African countries are part of a project through which Unitaid is investing $67 million to more quickly introduce new drugs in low- and middle-income countries, the group said, to avoid delays in introducing drugs that can exceed 10 years. The project also includes efforts to introduce adapted pediatric HIV drugs. – by Joe Green

Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.

Perspective

Elaine Abrams, MD

Kenya is one of three countries that Unitaid is supporting in a pilot project to introduce dolutegravir as a first step toward changing the first-line regimen. What Unitaid has done now is bring in generic dolutegravir for 27,000 people who could not tolerate the current first-line regimen as a way to gain experience with the drug.

The conversion to dolutegravir-based treatment as the first-line regimen is likely to happen when a generic version of the six-dose combination regimen is available, which is expected in 2018. It is not that [Kenya] is the first to use it, but they are just the first to get the generic dolutegravir tablet.

It is important to note because it is anticipated that use of integrase inhibitor-based therapies for first-line treatment will bring many advantages to people living with HIV and to governments running this program because these regimens have a better resistance profile, tend to have lower toxicities and are generally better tolerated.

From a clinician’s point of view, we’re likely to be able to treat more people with the same dollars because it is cost effective. The projected cost of the six-dose combination dolutegravir is projected to be less than the current regimen. Also, because dolutegravir is better tolerated, the expectation is that more people will stay on for the regimen longer.

Elaine Abrams, MD

Professor of epidemiology and pediatrics,

Columbia University Mailman School of Public Health

Disclosures: Abrams has attended a pediatric ART advisory board meeting for ViiV Healthcare, which originally developed dolutegravir. She also reports that she receives funding through USAID as part of a project to help countries transition to ART regimens that include dolutegravir.