The results of a 199-subject trial in China on the efficacy of HIV drugs Lopinavir and Ritonavir that India was looking at eagerly, has come out negative.
At 22.1 per cent, the mortality reported in the trial was substantially higher than the 11 per cent to 14.5 per cent mortality reported in initial studies of patients hospitalised with novel coronavirus (COVID-19), according to a study.
The overall documented mortality of COVID-2019, as given out by the World Health Organization (WHO) is 3.4 per cent.
“In hospitalised adult patients with severe COVID-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit,” researchers from the National Clinical Research Center for Respiratory Diseases and several other Chinese institutes reported in the New England Journal of Medicine (NEJM).
to recommend any specific treatment for suspected or confirmed patients with COVID-19. No specific anti-virals are recommended for treatment of COVID-19 due to lack of adequate evidence from literature. The use of Lopinavir/ Ritonavir in PEP regimens for HIV (4 weeks) is also associated with significant adverse events which many a times leads to discontinuation of therapy. In light of the above, Lopinavir/ Ritonavir should ONLY be used with proper informed expressed consent on a case to case basis for severe cases…along with supportive treatment as per need.”
PEP, or post-exposure prophylaxis, involves taking HIV medicines within 72 hours after a possible exposure to HIV to prevent becoming infected with HIV.
Asked whether India plans to report its experience with the use of the drug combination in the two patients (in Jaipur), ICMR’s head of epidemiology, Dr R R Gangakhedkar, had last week said, “This is too small a sample size. We will wait for the results of the 199 subject trial in China.”
In India, the drug combination is to be used in patients who have hypoxia, hypotension, new onset organ dysfunction (one or more) and also in “High Risk Groups” that includes people with Diabetes Mellitus, Renal Failure, Chronic Lung disease, Immuno — compromised persons or those above 60 years.
The Chinese researchers, though, have considered the possibility that the high mortality was because of a cohort that was very sick. “This randomized trial found that lopinavir-ritonavir treatment added to standard supportive care was not associated with clinical improvement or mortality in seriously ill patients with Covid-19 different from that associated with standard care alone. …Of note, the overall mortality in this trial (22.1%) was substantially higher than the 11% to 14.5% mortality reported in initial descriptive studies of hospitalized patients with COVID-19,1,2 which indicates that we enrolled a severely ill population,” they wrote.
The results of this trial notwithstanding, a combination of these two drugs, and this combination with interferons (proteins released by the body to combat some viruses), are one of the four drug options for which the WHO on Wednesday announced multi-country clinical trials. The other drugs to be tested are antiviral drug Remdesivir and antimalarial drug Chloroquine.
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