World’s Most Effective HIV Drug Rolled Out In Africa In Generic Version

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NAIROBI, Kenya – A generic version of dolutegravir (DTG), the drug of choice for the last two years for people living with HIV in high-income countries, is now available in Africa.

On 28 June, the government of Kenya and drug pricing and innovation mechanism Unitaid unveiled the new first-line drug in an effort to accelerate access to better antiretroviral (ARV) drugs for her people living with HIV. It becomes the first country in Africa to introduce the generic version of drug.

Dr. Robert Matiru, Unitaid director of operations, speaks at the launch

Medical experts said the drug – produced by Indian-based generic manufacturer Eurobindo Pharma Limited – has few side effects, is easier to take than other formulations (one small tablet taken daily) in use, and that those who use it are less likely to develop resistance.

Dr Jackson Kioko, Kenya’s Director of Medical Services, said dolutegravir offers better tolerability, fewer adverse drug reactions, fewer drug-drug interactions, and higher protection from resistance.

“A single drug, dolutegravir, will be used in combination with dual fixed-dose combination to constitute an alternative first-line regimen,” said Kioko.

Initially, Kenya’s Ministry of Health will put on the drug 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 drug was included in Kenya’s antiretroviral therapy (ART) treatment guidelines in 2016. It will be available at select health facilities across the country – for free – with the aim of making it widely available nationwide later in the year. The availability will be possible after the drug becomes commercially available to meet the country’s needs.

“Dolutergravir is of lower cost comparable to that of similar ARVs currently in use,” Kioko said in a statement read on his behalf by Dr Peter Kimuhu, head of health policy and planning at the Ministry of Health.

Doctors recommend it as a substitute for persons living with HIV (PLHIV) with efevirenz intolerance, as a preferred component of first line ART for HIV-infected people who inject drugs and will constitute a third-line regimen for PLHIV failing a second-line protease inhibitor-based regimen.

Unitaid is investing US$ 67 million to address the need for the drugs to avoid delays of more than 10 years before new drugs can be introduced in low- and middle-income countries. Its officials say the intervention also provides a key opportunity to test DTG’s use in routine treatment for the first time and to prepare national distribution channels.

At the launching ceremony, Unitaid donated 148,000 packets to Kenya, worth US$600,000.

“Since 2013, DTG has been available in America, it has been available in Europe as a first-line drug, and we have been waiting for it to land in the continent of Africa,” said Robert Matiru, the director of operations at Unitaid. “That day is today.”

Unitaid is currently in partnership with the Clinton Health Access Initiative (CHAI) and is working with partners including the World Health Organization, the Global Fund for AIDS, Tuberculosis and Malaria, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), national ministries of health, civil society and others.

“We needed to do this [avail the drug] because we had a drug that was working very well in developed countries and there was no reason why we should not have it in developing countries,” said Gerald Macharia CHAI vice-president for East and Southern Africa. “Bridging that gap between when as developing countries will adopt innovation that is already there – the lag has been much bigger – we are trying as CHAI to reduce that. We are trying to bring innovations to the market as quickly as they are available. DTG is one of those.”

This partnership is expected to save US$ 1.6 billion in treatment costs through 2024 – enough to provide access to medicines for an additional 3.2 million people for five years.

“Dolutegravir as a product compared to others is also cheaper to manufacture,” said Matiru. “You need less raw material, less active ingredients. So when you take this product to scale not only in Kenya but other countries in world and beyond, and achieve economies of scale, there will be incredible saving to health programs by using dolutegravir.”

Nigeria and Uganda will also be introducing DTG later this year as part of the project, ahead of the acceleration of uptake of the three-in-one fixed dose combination that would be made available by 2018. The fixed-dose combination, which would include tenofovir, lamivudine and DTG, is expected to significantly simplify treatment for people living with HIV.

The WHO recommended DTG as an alternative first-line regimen for adults and adolescents in 2015. But until now, people living with HIV in countries like Kenya could not access the drug.

Gerald Macharia, CHAI vice-president for East and Southern Africa

The WHO country representative in Kenya, Dr Rudolf Eggers, said with antiretroviral treatment (ART) scale-up set to continue over the next few years, it remains crucially important that manufactures, global policy planners and procurement agents anticipate future changes to treatment regimens, demands and generics pipeline in order to secure continued access to all antiretroviral ( ARV) medicines needed.

“We assume that these newer ARVs will significantly reduce the cost of treatment over time, considering its lower dosage,” Eggers said in a speech delivered at the event. “Given the decreasing funding available for ART, this would likely help in ensuring more people are put on treatment.”

Globally, more than 18 million people are on lifelong HIV treatment, but an almost equal number do not have access to treatment yet. In Kenya, approximately 1.5 million people are living with HIV, and just over one million are currently on ARVs.

Dhoughty Ogutu, a single mother of two and a PLHIV who is now on DTG, told a news conference at the meeting:

“I spent the better part of this year in hospital – two months in hospital – because efevirenz had completely failed. It did not fail because of adherence or anything else, it had failed because of the side effects.”

“I will say from my experience of using the drug, they talk about side effects, I have not been able to experience any… I can experience the difference – what efevirenz was doing to my body and what I am experiencing now with DTG.”

James Kamau from the Kenya Treatment Access Network said they would be seeking local manufacturing of the drug.


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