Tuberculosis (TB) is a major menace to public health and one of the leading causes of death linked to an infectious agent globally. The current standardized regimen for TB requires a treatment duration of at least six months. Before developing active disease, patients are infected by M. tuberculosis, leading to a latent tuberculosis infection (LTBI). Preventive treatment for four to nine months can prevent the progression of LTBI to TB. The long duration of TB and LTBI treatment represents a major obstacle for improving overall adherence to treatment and ultimately improving outcomes and patient acceptability.
Rifapentine is a drug which has been developed more than 50 years ago. Recent trial results have shown that rifapentine-based regimens have the potential to significantly shorten and simplify current treatment regimens for LTBI, down to one month, and TB, down to four months. Despite being approved by US FDA and included in WHO essential medicine list, rifapentine is still not registered in Europe. According to a recent survey by the Tuberculosis Network European Trialsgroup (TBnet), the largest European TB research and training network, rifapentine is available only in six out of 43 (14%) participating countries in the WHO Europe region. Signatories of three major European scientific societies involved in TB care (the European Society of Clinical Microbiology and Infectious Diseases, the European Respiratory Society and the European Society of Mycobacteriology) and of TBnet have authored a letter denouncing the lack of access to rifapentine and urging the manufacturer to register this drug in Europe. This letter was recently published in the European Respiratory Journal (Guglielmetti L. et al. ERJ 2022).
“The current situation is unacceptable: patients are being denied access to optimal care and health care providers to adequate tools to pursue the goal of tuberculosis control and elimination in Europe.”
says Lorenzo Guglielmetti from Sorbonne University & Pitié-Salpêtrière Hospital in Paris, France, Chair of the Study Group on Mycobacteria of the ESCMID (ESGMYC) and principal investigator of this study. “This letter shows that there is large scientific consensus on the importance of this drug. The drug manufacturer and all relevant stakeholders should coordinate efforts to provide expedite access to rifapentine to all patients who may benefit from this drug for treatment of TB or LTBI.”
„Access to rifapentine is a long-standing issue, particularly in Europe“,
adds Liga Kuksa from the Riga East University Hospital TB and Lung Disease Centre, Riga, Latvia, and chair of the TBnet. "Despite increasing demand and pressure from national TB programs and other TB organizations, the manufacturer has not yet filed rifapentine for registration at the European Medicine Agency. We must leverage public pressure to increase access to affordable care.“
Guglielmetti L, Günther G, Leu C, Cirillo D, Duarte R, Garcia-Basteiro A, Goletti D, Jankovic M, Kuksa L, Maurer FP, Méchaï F, Tiberi S, van Leth F, Veziris N, Lange C; on behalf of the ESGMYC, ESM, ERS, and the TBnet. Eur Respir J 59 (5) 2200388; DOI: 10.1183/13993003.00388-2022 Published 19 May 2022
Dr. Lorenzo Guglielmetti, MD PhD
Sorbonne University, Centre d’Immunologie et des Maladies Infectieuses (Cimi-Paris)
APHP, Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries