New possibilities of etiotropic therapy of coronavirus infection discussed at the Council of experts in Moscow

The current aspects of targeted therapy for the new coronavirus infection and, in particular, the prospects for the use of Esperavir^® (molnupiravir) were discussed by reputable clinicians and scientists, including members of the Russian Academy of Sciences.

The Council members came to a consensus that COVID-19 continues to pose a serious threat to human health and life. This indicates the need to include highly effective etiotropic therapy agents in the arsenal of doctors, which have universal action against RNA viruses, regardless of the variability of strains. Early initiation of targeted antiviral therapy is necessary to prevent the adverse development of the disease. At the same time, the RNA-dependent RNA polymerase, which provides reproduction of the main pathogens of respiratory viral infections, is of great interest as a target for suppressing viral replication.

Currently, international experience has been gained in the use of molnupiravir in the treatment of a new coronavirus infection. Data on the mechanism of action, pharmacological effects, pharmacokinetics, toxicity studies, and safety profile of the drug as a whole allow us to consider it as one of the most potential drugs for the treatment of new coronavirus infection. The effectiveness of molnupiravir exceeds standard therapy, regardless of the age of patients and the presence of comorbid conditions. The therapy is characterized by a favorable safety profile.

Based on the available clinical trial data, it is advisable to include molnupiravir in the treatment regimens of outpatient patients with COVID-19. Treatment with medications based on molnupiravir (in particular, Esperavir^®) should be initiated as early as possible after the onset of symptoms of the disease.

It is advisable to consider molnupiravir as a means of post-exposure prophylaxis of COVID-19, and given the high probability of virus persistence in Long-term COVID-19, it seems reasonable to use direct antiviral drugs beyond the acute period. The issue requires further study and appropriate clinical trials.

In particular, during the meeting it was noted:

"In clinical trials involving more than 3,000 patients (including patients of the older age group and patients with comorbid conditions) from around the world with varying degrees of severity of COVID-19, the drug showed high efficacy in reducing the amount of viral RNA, and on the fifth day of use, the virus was no longer isolated. in patients. In addition, molnupiravir provided a faster onset of clinical improvement, and the proportion of hospitalizations decreased by more than three times," said Alexander Dmitriev, PhD, Head of the Center for Epidemiologically Significant Infectious Diseases.

"The appearance of our domestic molnupiravir is an opportunity to provide decent effective treatment, as far as possible today, to the majority of our country's citizens," said Vladimir Chulanov, MD, Chief freelance Specialist in Infectious Diseases at the Ministry of Health of the Russian Federation, Deputy Director for Scientific Work and Innovative Development at the National Medical Research Center. Phthisiopulmonology and infectious Diseases" of the Ministry of Health of the Russian Federation.

"Drugs based on favipiravir (Areplivir) and molnupiravir (Esperavir) remain effective against the Omicron strain. The first one has been used in our practice for a long time, and we are just starting to use the second one in therapy. Both drugs are inhibitors of RNA-dependent RNA polymerase, although their mechanism is slightly different, so it is quite possible that they even have such a complementary effect. And they may find themselves today, in the situation of the spread of the active Omicron strain, our main drugs in the arsenal in the fight against this infection. The safety profile of Esperavir is very favorable, it is a short five–day treatment, and prescribing it early, especially in high-risk groups, would be the most appropriate tactic, in my opinion," Larisa Balykova, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Director of the Medical Institute, Head of the. Department of Pediatrics, N. P. Ogarev Mordovian State University.

"Drugs that affect RNA-dependent RNA polymerase, such as favipiravir and molnupiravir, are, in the opinion of a clinical pharmacologist, of undoubted interest, since they have high specificity and efficacy on the one hand, and a wide range of antiviral activity on the other. As part of the study, the main purpose of which was to determine the safety ofsafety, tolerability and pharmacokinetic parameters, by the fifth day of treatment with molnupiravir, the proportion of patients who had no clinical symptoms at all, i.e. patients with complete clinical recovery, was quite high (more than 40%). There was also an improvement in clinical symptoms compared to standard therapy," Balykova added.

Following the results of the expert council, the participants unanimously agreed on the need to promptly inform primary care physicians about the appearance of a highly effective remedy in their arsenal and provide training in the rational use of direct antiviral drugs. In addition, it was noted that the appearance of a drug based on molnupiravir of domestic production is a big breakthrough for the Russian pharmaceutical industry.

Participants of the meeting:

 — Vladimir Chulanov, MD, Professor of the Department of Infectious Diseases, Faculty of Medicine and Prevention, I.M. Sechenov First Moscow State Medical University, Deputy Director for Research and Innovative Development of the Federal State Budgetary Institution National Medical Research Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation, Chief Freelance Specialist in Infectious Diseases of the Ministry of Health of the Russian Federation;

 — Dmitry Pushkar, Academician of the Russian Academy of Sciences, MD, Professor, member of the Academic consortium of the Academic Community for the study of COVID-19, chief freelance specialist urologist of the Ministry of Health of the Russian Federation;

 — Larisa Balykova, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Director of the Medical Institute, Head of the Department of Pediatrics, Ogarev Mordovian State University;

 — Oksana Drapkina, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Director of the Federal State Budgetary Institution NMIC TPM of the Ministry of Health of the Russian Federation, Chief freelance specialist in Therapy and General Medical Practice of the Ministry of Health of the Russian Federation;

 — Alexander Gorelov, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Deputy Chairman of the Board of the Moscow Society of Pediatricians. Chairman of the Board of the National Scientific Society of Infectious Diseases (NNOI);

 — Dmitry Sychev, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Professor of the Russian Academy of Sciences, Rector of the Russian Academy of Medical Sciences

 — Sergey Avdeev, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Head of the Pulmonology Department of the Faculty of Medicine of the I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Head of the Clinical Department of the Federal State Institution "Research Institute of Pulmonology" of the FMBA of Russia, Chief freelance specialist pulmonologist of the Ministry of Health of the Russian Federation;

 — Dmitry Lioznov, MD, Professor, Director of the Smorodintsev Scientific Research Institute of Influenza, Ministry of Health of the Russian Federation;

 — Dmitriev Alexander, PhD, Head of the Center for Epidemiologically Significant Infectious Diseases;

 — Konstantin Kolontarev, MD, Professor, Head of the Academic department of the Faculty of Postgraduate Education of the Moscow State Medical University Department of Urology, Head of the Oncourology Department of the Moscow State Medical University. Spasokukotsky.