Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised …

…, N Hittel, C Petersen, C Wells, J Hafkin… - The Lancet …, 2019 - thelancet.com
Background Delamanid is one of two recently approved drugs for the treatment of multidrug-resistant
tuberculosis. We aimed to evaluate the safety and efficacy of delamanid in the first …

Delamanid: from discovery to its use for pulmonary multidrug-resistant tuberculosis (MDR-TB)

…, K Ohguro, M Yoshitake, R Gupta, L Geiter, J Hafkin - Tuberculosis, 2018 - Elsevier
Tuberculosis (TB), caused by Mycobacterium tuberculosis (MTB), is the leading cause of
death from an infectious disease globally. The widespread and ever-increasing resistance to …

Early outcomes in MDR-TB and XDR-TB patients treated with delamanid under compassionate use

J Hafkin, N Hittel, A Martin… - European Respiratory …, 2017 - Eur Respiratory Soc
Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) remain
significant global health challenges, with an annual incidence of approximately 480 000 and …

Compassionate use of delamanid in combination with bedaquiline for the treatment of multidrug-resistant tuberculosis

J Hafkin, N Hittel, A Martin… - European Respiratory …, 2019 - Eur Respiratory Soc
Patients with multidrug-resistant (MDR) tuberculosis (TB), in particular those with pre-extensively
drug-resistant (pre-XDR) and extensively drug-resistant (XDR)-TB, and those that fail …

Population pharmacokinetic and concentration-QTc analysis of delamanid in pediatric participants with multidrug-resistant tuberculosis

…, EM Svensson, X Wang, Y Wang, J Hafkin… - Antimicrobial agents …, 2022 - Am Soc Microbiol
A population pharmacokinetic analysis of delamanid and its major metabolite DM-6705 was
conducted to characterize the pharmacokinetics of delamanid and DM-6705 in pediatric …

Delamanid added to an optimized background regimen in children with multidrug-resistant tuberculosis: results of a phase I/II clinical trial

…, AC Hesseling, S Malikaarjun, J Hafkin - Antimicrobial Agents …, 2022 - Am Soc Microbiol
Delamanid has been demonstrated to be safe and effective for treatment of adult multidrug-resistant
tuberculosis (MDR-TB) and has been approved by the European Commission for …

Phase I single ascending dose and food effect study in healthy adults and phase I/IIa multiple ascending dose study in patients with pulmonary tuberculosis to assess …

…, KW Stinson, X Zhang, Y Liu, J Hafkin - Antimicrobial Agents …, 2023 - Am Soc Microbiol
OPC-167832, an inhibitor of decaprenylphosphoryl-β-d-ribose 2’-oxidase, demonstrated
potent antituberculosis activity and a favorable safety profile in preclinical studies. This report …

Cumulative fraction of response for once-and twice-daily delamanid in patients with pulmonary multidrug-resistant tuberculosis

…, K Hirota, Y Inoue, M Matsumoto, J Hafkin… - Antimicrobial agents …, 2020 - Am Soc Microbiol
Pharmacokinetic (PK) and pharmacodynamic (PD) analyses were conducted to determine
the cumulative fraction of response (CFR) for 100 mg twice-daily (BID) and 200 mg once-daily …

Compassionate use of delamanid in adults and children for drug-resistant tuberculosis: 5-year update

…, N Lazarevic, A Martin, J Hafkin… - European …, 2021 - Eur Respiratory Soc
Background Although delamanid has been approved for the treatment of multidrug-resistant
TB (MDR-TB) in numerous regions, in areas where it is not yet registered it can be accessed …

Incidence and risk factors for incomplete HBV DNA suppression in HIV/HBV‐co‐infected patients initiating tenofovir‐based therapy

JS Hafkin, MK Osborn, AR Localio… - Journal of viral …, 2014 - Wiley Online Library
Suppression of hepatitis B virus (HBV)‐DNA to undetectable levels is an important goal for
HIV/HBV‐co‐infected patients receiving anti‐HBV‐active antiretroviral therapy (ART), and …