Access to new medications for the treatment of drug-resistant tuberculosis: Patient, provider and community perspectives

Abstract

Multidrug-resistant tuberculosis (MDR-TB) is on the rise, and is difficult to treat. The approval of two new drugs, bedaquiline and delamanid, and growing evidence for the use of linezolid, offer renewed hope for addressing MDR-TB. However, access to these medicines remains a significant challenge. These drugs have not been registered for TB in most settings; barriers to preapproval access persist; and high pricing and intellectual property restrictions limit access. Many unanswered research questions about optimal use of these drugs also limit access, particularly for vulnerable populations. This review outlines challenges in accessing drugs encountered from the perspective of clinicians, patients and affected communities, and offers potential solutions.

The changing landscape in drug resistant-tuberculosis: an analysis of recent advances

“…Among them, linezolid has been clearly identified in two small randomized clinical trials [27,28] and different meta-analyses as the key drug for XDR-TB regimens [29,30], but frequent, and sometime severe side effects limit its use. Despite the Global Drug Facility is currently offering 600 mg pills at $8 (US), the market price unfortunately still limits its use in most developing countries [31].…”

“…Again price and injectable formulations reduce its availability for long treatments in most developing countries [31]. In any case, this group merits further evaluation, especially the new drugs with greater half-life allowing daily outpatient intake like ertapenem [35] or the new oral forms like faropenem [36].…”

Recruitment challenges for clinical trials with novel regimens for drug-resistant tuberculosis

“…This seems low in the face of the great need for novel anti-TB treatments [9]. What can be done to improve this figure?…”

Delamanid in multidrug-resistant tuberculosis: a guide to its use in the EU

“…amikacin, capreomycin, kanamycin) [19]. In addition, delamanid appears to offer a better tolerability profile, as these injectable agents may cause severe adverse events such as deafness, vestibular toxicity, electrolyte imbalances and renal impairment [19,23]. Delamanid-based therapy was generally well tolerated in clinical trials; however, its use may be limited by the potential risk of QT interval prolongation.…”