Items tagged with Treatment
Drug efficacious in MDR-TB (post)
A tuberculosis (TB) drug with a questionable safety profile increased the rate of sputum culture conversion in people with multidrug-resistant (MDR) disease, researchers reported.
FDA approval of bedaquiline — the benefit–risk balance for drug-resistant tuberculosis (post)
Bedaquiline was approved by the Food and Drug Administration (FDA) at the end of 2012 for the treatment of adults with multidrug-resistant pulmonary tuberculosis for whom an effective treatment regimen is not otherwise available (1). One complexity facing the FDA in reviewing the bedaquiline marketing application was that in one of the phase 2 studies, there were more deaths among patients who had bedaquiline added to a background antimycobacterial drug regimen than among those who had placebo added to the same regimen, despite relatively clear evidence of bedaquiline's efficacy in clearing Mycobacterium tuberculosis from sputum. Given this imbalance in mortality, the approval of bedaquiline has appeared paradoxical to some (2). But marketing applications that are reviewed by the FDA often rely on complex risk–benefit evaluations. (The 120-week final results of the aforementioned phase 2 study are reported by Diacon et al. in this issue of the Journal [pages 723–732]; the marketing application, however, contained only efficacy data that were available at week 72.)
Tuberculosis drugs better absorbed on an empty stomach (post)
MUNICH — When first-line tuberculosis (TB) drugs are taken with food, there is a reduction in maximum plasma concentration and bioavailability of the drug than when taken on an empty stomach, according to the results of a new pharmacokinetic study.
Critical Path Institute receives second grant for advancing tuberculosis treatments (post)
New multi-year grant continues work to study pressing public health crisis
Adherence to ART and XDR-TB therapy in Kwa-Zulu Natal province (post)
Adherence to antiretroviral therapy (ART) approached 90% in a 104-person prospective study in KwaZulu-Natal province, South Africa. Adherence to multiple medications for extensively drug-resistant tuberculosis (XDR-TB) was 20% lower.
Lab rat tests spark TB drug boomerang fear (post)
New Delhi, Sept. 21: A drug routinely prescribed for tuberculosis could possibly make people vulnerable to repeat TB attacks by harming a key protective arm of the immune system, a study in India on laboratory mice suggests.
Daiichi Sankyo and Daiichi Sankyo Espha submit supplemental New Drug Application in Japan for “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP” (post)
Tokyo, Japan (October 1, 2014) – Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) today announced that it and its domestic generic subsidiary, Daiichi Sankyo Espha Co., Ltd. (hereafter Daiichi Sankyo Espha), have submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit® Tablets 250mg and 500mg, Granules 10% (generic name: Levofloxacin hemihydrate) and Levofloxacin Tablets 250mg DSEP and 500mg DSEP, Granules 10% DSEP*1 for the treatment of pulmonary and other tuberculosis disorders.
India: Government drags feet on ‘effective’ anti-TB drug (post)
MUMBAI: Bedaquiline, the first anti-tuberculosis drug manufactured after rifampicin almost 50 years ago, has been effective in five Indian patients, shows a new study by a city hospital. But it cannot be prescribed to other drug-resistant TB patients because the Indian government, unlike the West and the World Health Organization, has yet to approve its use.
Namibia: Occurrence and clinical management of moderate-to-severe adverse events during drug-resistant tuberculosis treatment: a retrospective cohort study (post)
Abstract (provisional)
Preliminary data show high success rate for dramatically shortened multidrug-resistant TB treatment option (post)
Thursday, 30 October, 2014, Barcelona, Spain – A nine-month treatment regiment for multidrug-resistant tuberculosis (MDR-TB) appears to be as effective as a 12-month regiment, according to data from two new studies being presented today at the 45th World Conference on Lung Health in Barcelona, Spain.
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