Pharma & drug development

An accessible treatment

Under a breakthrough pricing agreement, a generic antiretroviral for HIV / AIDS containing dolutegravir will become available across the developing world for just $75 per person per year.  Abi Millar finds out more. 

In September, the United Nations programme UNAIDS made a remarkable announcement: a state-of-the-art HIV drug will be launched in lower-income countries at a much-reduced price. The drug will be available for no more than $75 per person per year, greatly improving access to treatment.

At present, there are 36.7 million people living with HIV across the world, 95% of whom live in low or middle-income countries. While antiretroviral therapies significantly improve patients’ health, only 19.5 million sufferers – little more than half – have access to these life-saving medicines.

UNAIDS, however, has ambitious goals. By 2020, the organisation hopes that 90% of people living with HIV will know their status; that 90% of that group will be on antiretroviral therapies; and that 90% of that group will be virally suppressed. This new pricing agreement looks set to bridge the gap between the aspiration and the reality.

“For the first time ever, the pricing deal has enabled the best available treatment for HIV to come to market at a price lower than the current standard of care,” says Carolyn Amole, senior director of the HIV Access Program at the Clinton Health Access Initiative (CHAI). “This eliminates a key barrier to uptake, and governments do not need to decide between putting their patients on a costly but better drug, versus a more affordable but less effective regimen.”

Clinical superiority

The treatment in question, a once-daily fixed dose combination, contains a generic form of dolutegravir (DTG) along with two other medicines. Marketed as Tivicay by ViiV Healthcare, DTG received fast-track FDA approval in 2013, and has subsequently featured on the World Health Organization’s List of Essential Medicines.

“DTG is a best-in-class integrase inhibitor, recommended by the World Health Organization (WHO) as an alternative first-line HIV regimen,” says Amole. “It is also the preferred treatment by the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, among many others.”

In clinical trials, it has shown several advantages over other treatment regimens, including fewer side effects and a lower risk of viral resistance. As a result, it is considered one of the best HIV drugs around, with a patient base of around 300,000 people in high-income countries.

Unfortunately, its global availability has been hampered by high costs. For reference, in the USA, a month’s supply of dolutegravir tablets costs $1,842.82, rising to $3,118.62 when taken in a fixed dose combination.(These figures, from a US government website, were true as of October 2017.)

Typically, lower income countries have to wait until affordable generic drug combinations become available. For instance, many people in the developing world take a combination of tenofovir, lamivudine and efavirenz (TLE 600), a treatment which, as of Q3 2017, cost around $85 per patient per year.

The new generic drug combination (called TLD) was developed by both Mylan and Aurobindo under licensing agreements from ViiV Healthcare. Both versions received tentative FDA approval in August 2017. Compared to what was previously available, the drug is clinically superior and less expensive – an unprecedented development in this field.

Rapid transition

As might be expected for a deal of this kind, there were many parties involved. For instance, the Bill & Melinda Gates Foundation serves as the guarantor and donor, the Clinton Health Access Initiative brokered the deal, and the governments of South Africa and Kenya are key partners.

“CHAI was funded by Unitaid and the UK Government’s Department for International Development (DFID) for this work,” says Amole. “This critical funding allowed CHAI to bring the various other partners to the table, drive consensus toward the urgent need for TLD, and to help negotiate prices with manufacturers. CHAI also helps drive uptake of the medication in countries.”

Since the deal was announced, a number of countries and major procurers have placed orders. Although the timing of rollout in each country depends on national regulatory requirements, there is already a lot of momentum.

“A number of high-burden countries are already planning rapid transitions for 2018,” says Amole. “CHAI projects that up to 21 million patients in low- and middle-income countries will receive TLD treatment by 2025, in large part facilitated by this pricing agreement.”

South Africa, for instance, has said it will switch to TLD as its preferred treatment option next year. At present, the country has around 7.1 million people living with HIV, around 4 million of whom are on treatment. It is thought the switch could save the public sector up to $900 million over the next six years, allowing more patients to be treated.

“The dolutegravir-based fixed-dose combination will greatly benefit our patients due to its superior therapeutic qualities,” said the country’s minister of health, Dr Aaron Motsoaledi. “Ramping up treatment with good viral suppression will enable us to reach HIV epidemic control more quickly. We are aiming at launching the new tender in April 2018.”

Three countries (Kenya, Nigeria and Uganda) have already introduced a generic form of DTG. This drug, funded by Unitaid in partnership with CHAI, is taken as a single drug along with a dual fixed-dose combination. The idea was to lay the groundwork for TLD and create familiarity among healthcare workers.

Transforming the market

These early adopters are surely paving the way for things to come. According to CHAI, the average country will be able to save 10-15% on the costs of treatment.

“Ministries of Health and program managers from the 92 low- and middle-income countries covered under the agreement should anticipate being able to order TLD under the agreements at a projected average price of US$75 per patient, per year,” says Amole. “In addition to these savings, overall treatment costs are expected to decrease due to reduced side effects, and reduced or delayed likelihood of treatment failure.”

She points out that while evidence of the safety and efficacy of DTG is still limited in certain populations (notably young children and pregnant women), there are ongoing clinical studies that should yield results in the next few years.

“While it is currently not recommended for use in young children, the WHO will be reviewing all new data regarding the use of DTG in children by the end of 2017. Initial reports of DTG use among children look reassuring in terms of efficacy, safety and tolerability,” she says.

With so many patients in need of treatment, the drug has the potential to transform the antiretroviral market – halting the spread of infection and improving the quality of life for millions of people. Over the next few years, we can expect to see a swift and effective transition to DTG.

This article appears in the January 2018 edition of Pharma Technology Focus

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