‘New standard of care’ for MERS reduces mortality in hospitalized patients
A combination of interferon beta-1b and lopinavir-ritonavir reduced mortality in hospitalized patients with Middle East respiratory syndrome, according to results from a randomized clinical trial in The New England Journal of Medicine.
“This is the first randomized clinical trial that evaluated therapeutics for MERS,” Yaseen M. Arabi, MD, FCCP, FCCM, ATSF, chairman of the intensive care department and medical director of respiratory services at King Saud bin Abdulaziz University for Health Sciences King Abdullah International Medical Research Center in Riyadh, Saudi Arabia, told Healio.
“It establishes a new standard of care for MERS,” Arabi said.
There have been almost 2,500 cases of MERS since the severe respiratory infection was first reported in Saudi Arabia in 2012, and around 35% of patients have died. MERS is caused by the coronavirus MERS-CoV, and like the coronavirus that causes COVID-19, questions remain about how it spreads.
Evidence indicates that dromedary camels are a major reservoir for spillover to humans, and the virus also has spread through close contact with an infected patient, including in hospitals.
According to Arabi, preclinical data showed that MERS-CoV is inhibited by interferon beta, and is more sensitive to interferon effects than SARS-CoV-1, the coronavirus that caused SARS.
Arabi and colleagues performed a randomized, adaptive, double-blind, placebo-controlled trial that included 95 patients with lab-confirmed MERS from nine sites in Saudi Arabia — 43 who were given the combination therapy and 52 who were given a placebo for a period of 14 days.
The combination therapy consisted of a subcutaneous injection of interferon beta-1b on alternate days and oral lopinavir-ritonavir in tablet form every 12 hours, unless patients were unable to take medicine by mouth, in which case they received lopinavir-ritonavir as a 5-ml suspension every 12 hours through a nasogastric tube. The trial’s primary outcome was 90-day all-cause mortality.
Overall, 12 (28%) of the patients who received the combination therapy and 23 (44%) of patients who took placebo had died by day 90. The researchers calculated a risk difference of –19 percentage points between the two groups (P = .024). They observed serious adverse events in four (9%) patients in the intervention arm and 10 (19%) in the placebo arm.
According to Arabi and colleagues, in light of the COVID-19 pandemic, the data and safety monitoring board recommended in April that the trial stop enrolling participants and that researchers “proceed with all haste in analyzing and reporting the results in peer-reviewed format.”
“Given the rare nature of MERS, the sample size was small, but that [is] why we used an adaptive design,” Arabi said. “Nevertheless, the findings show [a] significant reduction in mortality.”