Major advances in the battle over access to key TB treatment
Some exact excerpts are used from the source material listed below.
In the latest twist in a prolonged battle over access to a lifesaving medicine for drug-resistant tuberculosis (TB), the pharmaceutical company Johnson & Johnson (J&J) has agreed not to enforce some of its patents on the drug, bedaquiline. The move will make generic versions available in many low- and middle-income countries (LMICs).
The deal was announced yesterday by the United Nations–affiliated Stop TB Partnership, whose Global Drug Facility (GDF) purchases and makes TB drugs available at affordable prices to countries in need. J&J agreed to provide GDF with licenses enabling the organization to procure and supply generic forms of the drug in dozens of countries the organization supplies.
GDF hopes that generic competition will drive down the price of a course of the medicine, which is taken with other oral medications to combat multidrug-resistant TB (MDR TB), a life-threatening disease that primarily afflicts people living in poverty, people living with HIV, and injection drug users.
Drug-resistant tuberculosis is a leading cause of morbidity worldwide; only one-third of persons initiate treatment and outcomes are often inadequate. Several trials demonstrate 90% efficacy using an all-oral, six-month regimen of bedaquiline, pretomanid, and linezolid (BPaL), but significant toxicity occurred using 1200 mg linezolid. After U.S. FDA approval in 2019, some U.S. clinicians rapidly implemented BPaL using an initial linezolid 600 mg dose adjusted by serum drug concentrations and clinical monitoring.
As part of the BPaL Implementation Group our SEATRAC Clinical Core consultant David Horne and SEATRAC Internal Advisory Board Member Masa Narita analyzed data from U.S. patients treated with BPaL between 10/14/2019 and 4/30/2022. They determined that effective treatment required less than half the duration recommended in ATS/CDC/ERS/IDSA 2019 guidelines for drug-resistant tuberculosis. The BIG cohort demonstrates that early implementation of new tuberculosis treatments in the U.S. is feasible.
Bedaquline is now on WHO’s list of essential medicines and remains the linchpin of MDR TB treatment regimens. It works by interfering with the generation of energy-storing ATP molecules in the microbe that causes the disease, Mycobacterium tuberculosis. However, bedaquiline remains unavailable in many countries despite its superior efficacy and safety as part of a multidrug regimen compared with older drug combinations. In part, that is because of cost; bedaquiline accounts for up to 70% of the price of these multidrug regimens.
J&J’s new agreement for 52 LMICs where the company has no secondary patents, “brings the total to 96 countries we can supply with generics as of July 19,” says Brenda Waning, chief of GDF. “It’s a massive advancement. It’s a new way of pharma working with a not-for-profit like GDF to promote access.”
Even if improved pricing increases access to bedaquiline, MDR TB will remain a deadly threat, Waning cautions, because so many cases go undiagnosed. “It’s difficult for the health systems to find people with TB, to get them in care, and to keep them in care,” she says. “If you can’t find them, even if the drug is free, it doesn’t matter.”
Sources:
Major drug company bends in battle over access to key TB treatment, Wadman, M Science.
Haley CA, Schechter MC, Ashkin D, Peloquin CA, Cegielski JP, Andrino BB, Burgos M, Caloia LA, Chen L, Colon-Semidey A, DeSilva MB, Dhanireddy S, Dorman SE, Dworkin FF, Hammond-Epstein H, Easton AV, Gaensbauer JT, Ghassemieh B, Gomez ME, Horne D, Jasuja S, Jones BA, Kaplan LJ, Khan AE, Kracen E, Labuda S, Landers KM, Lardizabal AA, Lasley MT, Letzer DM, Lopes VK, Lubelchek RJ, Macias CP, Mihalyov A, Misch EA, Murray JA, Narita M, Nilsen DM, Ninneman MJ, Ogawa L, Oladele A, Overman M, Ray SM, Ritger KA, Rowlinson MC, Sabuwala N, Schiller TM, Schwartz LE, Spitters C, Thomson DB, Tresgallo RR, Valois P, Goswami ND; BPaL Implementation Group.
Clin Infect Dis. 2023 May 30:ciad312. doi: 10.1093/cid/ciad312.
Global Drug Facility Update on Access to Bedaquiline | Stop TB Partnership, StopTBPartnership, https://www.stoptb.org/
