First-ever multi-drug Ebola trial begins in Congo

Morning MEDtalks with Dr KK Aggarwal

New Delhi, November 29, 2018:

Democratic Republic of the Congo begins first-ever multi-drug Ebola trial: The Ministry of Health of the Democratic Republic of the Congo (DRC) has announced that a randomized control trial has begun to evaluate the effectiveness and safety of drugs used in the treatment of Ebola patients. The trial is the first-ever multi drug trial for an Ebola treatment. It will form part of a multi-outbreak, multi-country study that was agreed to by partners under a World Health Organization (WHO) initiative.

“While our focus remains on bringing this outbreak to an end, the launch of the randomized control trial in DRC is an important step towards finally finding an Ebola treatment that will save lives,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Until now, patients have been treated under a compassionate use protocol, with drugs that showed promise and had a good safety profile in laboratory conditions. The giant step DRC is taking now will bring clarity about what works best, and save many lives in years to come. We hope to one day say that the death and suffering from Ebola is behind us.”

Until now, over 160 patients have been treated with investigational therapeutics under an ethical framework developed by WHO, in consultation with experts in the field and the DRC, called the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). The MEURI protocol was not designed to evaluate the drugs. Now that protocols for trials are in place, patients will be offered treatments under that framework in the facilities where the trial has started. In others, compassionate use will continue up to the time when they join the randomization. Patients will not be treated noticeably differently from before, though the treatment they receive will be decided by random allocation. The data gathered will become standardized and will be useful for drawing conclusions about the safety and efficacy of the drugs… (WHO).

Compromising patient protections to lower drug costs could harm people with cancer: Statement by Clifford A. Hudis, MD, FACP, FASCO, American Society of Clinical Oncology (ASCO) Chief Executive Officer issued November 27, 2018:

“While ASCO supports efforts to control drug prices, we are keenly aware that optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence. Therefore, ASCO has significant concerns about the Centers for Medicare & Medicaid Services’ (CMS) proposed rule to reduce the number of prescription drugs that must be made available to Medicare beneficiaries with chronic, potentially life-threatening illnesses including cancer.

“Cancer drugs are currently a protected class under Medicare, and as such, beneficiaries are effectively guaranteed access to these treatments. CMS’ proposal, however, would weaken the current protections for cancer drugs and potentially create access issues for patients. In particular, provisions in the proposal that would allow step therapy and other potentially restrictive utilization management strategies could not only delay patient access to proper treatments, they could potentially lead to irreversible disease progression and other significant patient health risks.

“ASCO is dedicated to supporting efforts that lower the cost of prescription drugs and strengthen the nation’s healthcare delivery system, while preserving access to appropriate and optimal high-quality care. We are assessing CMS’ proposal and its likely impact on Americans with cancer and will submit constructive feedback during the open comment period. We look forward to working with the agency on a sound solution for rising cancer care costs that does not limit access to optimal care.”

CO2 emissions on the rise for first time in four years: “Emissions Gap Report 2018”, a new report released on Tuesday by the United Nations Environment Programme (UNEP) shows that global carbon dioxide (CO2) emissions rose again during 2017 after a three year hiatus, highlighting the imperative for countries to deliver on the historic Paris Agreement to keep global warming to below 2°C above pre-industrial levels. The report comes just days before the key UN climate change conference known as COP 24, taking place in Katowice, Poland, with the agency urging nations to triple their efforts to curb harmful emissions… (UN, Nov. 27, 2018).

New clinical practice guidelines from the American Academy of Pediatrics (AAP) on maintenance intravenous fluids in children in surgical (postoperative) and medical acute-care settings, including critical care and the general inpatient ward recommends that “patients 28 days to 18 years of age requiring maintenance IVFs should receive isotonic solutions with appropriate potassium chloride and dextrose because they significantly decrease the risk of developing hyponatremia”… (Nov. 26, 2018, Pediatrics)

The US FDA has granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.”

Top News from ESMO 2018: Immunotherapy plus targeted drug in first-line kidney cancer: Adding immunotherapy to a targeted agent significantly improved progression-free survival when compared with a targeted agent alone in the first line treatment of advanced renal cell cancer, suggests interim results from the JAVELIN Renal 101 trial. The combination therapy, comprised of the anti-PD-L1 drug avelumab and the vascular endothelial growth factor tyrosine kinase inhibitor axitinib, was pitted against the current standard of care, sunitib. Combination therapy improved medial PFS by 39% in patients who tested positive for PD-L1 expression and by 31% in the overall patient population. The objective response rate with avelumab + axitinib was not quite toxic as that seen with sunitinib, and the combination therapy had a favourable safety profile.

As this was a preliminary analysis, the overall survival data are immature, although there was a signal for an increase in median overall survival. Study presenter Robert J Motzer, MD of Memorial Sloan Kettering Cancer Center, New York City said the findings “support the potential of avelumab + axitinib as a new treatment approach for patients with advanced RCC” (Medscape).

Video to watch: TEDx Video: Doctor-patient relationship www.youtube(dot)com/ watch?v=i9ml1vKK2DQ

Dr KK Aggarwal
Padma Shri Awardee
President Elect CMAAO
President Heart Care Foundation of India