HIV Drug Combo Found Ineffective Treating COVID-19 Patients
Lopinavir ritonavir treatment delivered no benefit beyond standard care
According to a new study in The New England Journal of Medicine (NEJM), the treatment with the combination of lopinavir-ritonavir was not very effective.
This combo did not significantly advance the time to clinical improvement, decrease mortality, or lower the detectable level of throat viral RNA among patients with serious cases of COVID-19 disease.
Published on March 18, 2020, these researchers concluded ‘in hospitalized adult patients with severe Covid-19 disease, no benefit was observed with lopinavir-ritonavir treatment beyond standard care.’
Additionally, in a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day the standard care.
Furthermore, there was no discernible effect on viral shedding.
This is an important observation since this drug combo is supposed to act as a direct inhibitor of viral replication, the inability to suppress the viral load and the persistent detection of viral nucleic acid, strongly suggest that it did not have the activity desired.
However, this data set is incomplete, as the lopinavir-ritonavir treatment was stopped early in 13.8% of these patients because of adverse events.
This study was led by Bin Cao, M.D., of the Department of Pulmonary and Critical Care Medicine and the Center of Respiratory Medicine at the National Clinical Research Center for Respiratory Diseases and the China-Japan Friendship Hospital, and the Institute of Respiratory Medicine at the Chinese Academy of Medical Sciences.
This team found the overall mortality in this trial (22.1%) was substantially higher than the up to 14.5 percent mortality reported in initial descriptive studies of hospitalized patients with Covid-19 disease. These adult patients had an oxygen saturation of 94% or less.
Dr. Cao’s team concluded ‘this indicates that this study enrolled a ‘severely ill population.’
In addition, ‘These observations are hypothesis-generating and require additional studies to determine whether the lopinavir-ritonavir treatment given at a certain stage of illness, could reduce some complications in Covid-19 disease,’ concluded this team’s comments.
This trial was initiated in rapid response to the public health emergency in China, at which time there was very limited information about clinical outcomes in hospitalized patients with Covid-19.
It was an open-label, individually randomized, controlled trial conducted from January 18, 2020, through February 3, 2020, at Jin Yin-Tan Hospital, Wuhan, Hubei Province, China.
A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization, with 99 people assigned to the lopinavir-ritonavir group. The median age of these patients was 58 years, and 60 percent were men.
In an accompanying commentary, Harvard professors said that completing this study was “a heroic effort” and stressed that, “results of such trials, providing either convincing positive or convincing negative findings, will be central to clinical care as the dangerous coronavirus outbreak continues,”
However, this trial was open-label, and since the endpoints were being evaluated or influenced by clinicians who were aware of treatment assignment, they were susceptible to potential bias.’
COVID-19 Clinical Trial news published by Precision Vaccinations.
- Covid-19 — The Search for Effective Therapy
- A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19
- A randomized, controlled open-label trial to evaluate the efficacy and safety of lopinavir-ritonavir in hospitalized patients wi
- Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive stud