Global health agency Unitaid and the Clinton Health Access Initiative (CHAI) have announced in a statement a groundbreaking pricing agreement with pharmaceutical company Hetero Labs to make darunavir, boosted with ritonavir (DRV/r), available as a second-line therapy for people living with HIV in low- and middle-income countries for US$210 per patient, per year.
Darunavir (DRV) in combination with ritonavir, is a best-in-class protease inhibitor, proven to be effective both in patients who have never been treated for HIV and those who have experienced multi-drug resistance. DRV is easier to take and less toxic than existing protease inhibitors used in second-line treatment.
Despite being available in the United States and other high-income countries for more than a decade, low- and middle-income countries still lack access to an affordable, quality generic version of the drug. Through this agreement, Hetero Labs Ltd’s World Health Organization (WHO) prequalified DRV/r will be available in low- and middle-income countries for US$210 per patient per year, or US$17.50/pack (plus shipping and insurance).
This price is cheaper than the well-established but suboptimal alternative option, lopinavir/ritonavir (LPV/r).
Kenly Sikwese, HIV advocate and head of the African Community Advisory Board (AfroCAB) stated, “It is fantastic to finally have a robust, more efficacious protease inhibitor for the treatment of HIV. Since 2011, the community has been advocating for the use of DRV in second-line, and this milestone is a critical step to addressing the longstanding inequity in access to this optimal HIV treatment in low- and middle-income countries. We look forward to seeing policymakers across the globe accelerate access to this very important drug for communities.”
Second- and third-line therapies are critical for people living with HIV where first-line treatment may not be an option, due to medication resistance or intolerance. However, there are barriers to commercialising DRV/r in low-resource settings, including the higher cost of producing the DRV active pharmaceutical ingredient in comparison to that of other protease inhibitors, as well as availability of DRV in a fixed-dose combination with ritonavir.
Until now, this made the product too expensive for national treatment programmes in low- and middle-income countries to afford, relying instead on sub-optimal products like LPV/r.
To tackle these barriers and others like them, Unitaid has invested in CHAI since 2016 to bring the best HIV medications to market more quickly and integrate them into treatment programmes in the low- and middle-income countries that need them most.
Unitaid Executive Director Dr Philippe Duneton said, “Ensuring equitable access to the best HIV treatments is at the heart of what Unitaid does. This agreement with Hetero marks an important moment in accelerating the development and availability of a long-awaited generic formulation of darunavir/ritonavir. It is vital that all those living with HIV who cannot stay on first-line treatment have access to a quality second-line product, and we are proud of our work with CHAI to make this happen.”
Joy Phumaphi, CHAI Interim Co-CEO, stated, “Access to this best-in-class second-line HIV treatment is long overdue. We are grateful that through our partnership with Unitaid, patients in low- and middle-income countries will now be able to access the same high-quality second-line medication as those in high-income countries, enabling more patients to remain on treatment and save lives. We look forward to working with our government and community partners to quickly deliver this medication to patients.”
The agreement not only ensures an affordable price, but that the product will be registered widely in low- and middle-income countries using the WHO Collaborative Registration Procedure (CRP) for prequalified products. The CRP accelerates registration through information-sharing between the WHO Prequalification of Medicines Programme (PQP) and national medicines regulatory authorities.
To reach this point, CHAI and Unitaid drew on years of experience on both the supply and demand side of the HIV therapy market. CHAI engaged with the originator company, Janssen, and generic drug manufacturers to encourage data sharing, and ensure a generic product was quickly developed and filed with stringent regulatory and national drug regulatory authorities.
Unitaid provided an innovative financial incentive to secure a highly competitive yet sustainable price, designed to partially offset the high costs of manufacturing until economies of scale are achieved. These efforts helped ensure that affordable pricing was available in low- and middle-income countries from day one, paving the way for adoption of the product.