Aurum Institute on behalf of the IMPAACT4TB project, congratulates Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria and Sanofi for having reached a volume-based agreement, securing a significant price discount for rifapentine (Priftin®)
Hyderabad (31 October 2019) - A new volume-based agreement announced today by Unitaid, the Global Fund and Sanofi will drastically lower the price of rifapentine (Priftin®), a critically important drug used to prevent tuberculosis (TB). The agreement with Sanofi brings Priftin® 150mg tablets down from €13.60/pack of 24 tablets (current GDF access price) to a net discounted ex-factory price of €4.62/pack of 24 tablets (a 66% discount). The discounted price will be available to the public sectors of low-income countries, lower-middle income countries, and upper-middle income countries with a high burden of TB and TB/HIV.
The agreement comes at a time when Aurum Institute and its partners prepare to roll-out a short regimen for preventing TB—three months of rifapentine and isoniazid treatment (3HP)—to 12 high-burden TB countries. The agreement lowers a patient treatment course of Priftin® from $45 to $15. Priftin® is currently the only quality assured rifapentine formulation available for short-course treatment of latent TB infection.
“In 2018, an estimated ten million people contracted tuberculosis, an unimaginable number,” said Gavin Churchyard, founder and CEO of the Aurum Institute. “We know how to prevent TB disease in some of the most vulnerable people, but innovations in prevention will only sit on the shelf if the price puts the solution out of reach. Now that we have a short-course TB preventive therapy that is affordable, it’s time for the world to come together to make sure that these people can live healthy and productive lives.”
TB can lie dormant for decades before it strikes; this is called “latent TB infection.” People with latent infection—almost a quarter of the globe—have no symptoms, are not contagious and most of them don’t know they are infected. If left untreated, latent infection can develop into active TB, the form of TB that makes people sick and is capable of being transmitted from one person to another.
Treatment of TB infection is referred to as TB preventive therapy (TPT) and is one of the most powerful ways to prevent TB. The goal of TPT is to prevent people who are already infected with the TB bacterium from falling ill with active TB disease.
In March 2019, study results presented at the Conference on Retroviruses and Opportunistic Infections (CROI) showed that weekly administration of rifapentine and isoniazid for three months (3HP) in adults with HIV taking dolutegravir (DTG) was well-tolerated, with no need for dose adjustment. These findings are significant given that people living with HIV are at high risk of developing TB and are 20 to 37 times more likely to move from latent infection to active TB. They also allowed tenofovir/lamivudine/dolutegravir (TLD) transition countries to move forward with co-administration of 3HP and DTG. But until now, the price of rifapentine remained an obstacle for low- and middle-income countries to implement this innovation.
“Today’s agreement will kick-start the global roll-out of more effective TB preventive therapy,” Unitaid Executive Director Lelio Marmora said. “It is in emphatic, tangible response to the call to action made last year at the high-level meeting of the United Nations General Assembly on the fight against tuberculosis.”
The 3HP regimen offers a shorter, safer alternative to the earlier standard of care—isoniazid preventive therapy (IPT)—in which people take isoniazid every day for between six and 36 months. In February 2018, the World Health Organization (WHO) released consolidated guidelines for the treatment of latent TB infection that recommend the use of 3HP for people living with HIV and contacts of TB cases of any age in high TB burden settings.
Priftin® is already on the list of WHO prequalified products and received marketing authorization in numerous countries including the United States, South Africa, the Philippines and Indonesia.
The Aurum Institute, and its partners under the IMPAACT4TB project, has been facilitating the regulatory approval of 3HP products in project countries. IMPAACT4TB will support 3HP uptake in 12 high-burden countries, which represent 46% of the global TB burden and 84% of the current IPT uptake. IMPAACT4TB will initiate the first order under this agreement of 325,000 patient packs in Malawi, Mozambique, Zimbabwe, Kenya, Tanzania, Ethiopia, Cambodia, Indonesia and Ghana. In high TB burden countries where Priftin® is not yet registered, an importation waiver to use it may be obtained through the Global Fund, the Global TB Drug Facility, WHO and other international development agencies.
“With this new price in hand, we are now ready to start 400,000-600,000 people on 3HP across 12 countries,” added Professor Churchyard. “The next few years will test our political resolve—if we truly want to stifle the TB pandemic, we need to make sure preventive treatment gets to those people who are most at risk.”
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