At the recent FDA workshop on narrow-spectrum antibiotic development, the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the
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Posted in The Viewpoint |
Tagged 30-day mortality, antibiotic blog, antibiotic efficacy, bacteriological response, clinical response, FDA, Harald Reinhart, HBV, HCV, HIV, immunity, mortality endpoint, outcome variables for antibiotic efficacy, surrogate endpoints, survival, viral load, VL |
For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. They are just too cheap, right? Well, with the exception of HCV and some newer HIV drugs, few compounds have ever reached the
Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany → Like this: Like Loading...
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Tagged Abbott, Achaogen, adrenaline, Alexion, aminoglycoside, antibiotic blog, Avycaz, BARDA, BL/BLI combinations, Ceftazidime/avibactam, Ceftolozane + tazobactam, CMS, Cubicin, Cubist, daraprim, drug pricing, epinephrine, EpiPen, eravacycline, FDA, FDA guidances, Genzyme, Gilead, Harald Reinhart, Harvoni, HCV, HIV, IMI, IMS, Mylan, NICE, omadacycline, plazomicin, price gauging, pyrimethamine, Shkrely, Soliris, solithromycin, tetracycline, Zerbaxa |
The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens. The trial which enrolled 4685
Continue reading The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower → Like this: Like Loading...
Posted in Did you know...?, Recent Literature, The News, The Viewpoint |
Tagged 80/20 rule, AIDS, AIDS defining event, antibiotic blog, CD4 count, cost of HIV medicines, HAART, HIV, HIV treatment, Insight study, Kaiser Family FOundation, Medicaid spending on HIV, NEJM, NNT, Norvir, number needed to treat, Pareto principle, Prezista, Ryan White Act, Truvada, viral load, VL |
It was déjà vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick
Continue reading 2014: The Year That Changed The Landscape of HCV Therapy → Like this: Like Loading...
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Tagged approval, Bartenschlager, boceprevir, cirrhosis, DAA, FDA, HAART, Harvoni, HCV, HIV, Incivek, ledipasvir, LLOD, LLOQ, NS3B/4A, NS5a, NS5B, OI, Olysio, Peg-interferon, polymerase, protease, replicon, ribavirin, simeprevir, sofosbuvir, Sovaldi, SVR, telaprevir, Victrelis, viral load, VL |
A Phase 1 study evaluating tigecycline (Tygacil®) to treat refractory Acute Myeloid Leukemia is currently underway?  Niacin extended release tablets (nicotinic acid, Niaspan®) was associated with a significantly higher rate of infections (appendicitis, bronchitis, cellulitis) compared to placebo in
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Posted in Did you know...? |
Tagged acute myeloid leukemia, AIM-HIGH, aminoglycoside, AML, antifungal, calcineurin inhibitor, CARDS, cyclophilin binder, cyclosporine, DEB-025, HCV, HIV, ICU, M. pneumonia, macrolide, mTORC1, mycoplasma, Niacin, Niaspan, nicotinic acid, rapamune, rapamycin, sirolimus, tigecycline, Tygacil |