Introduction. Ensuring the safety of medicines is the basis for the existence and functioning of any pharmacovigilance system as a type of activity aimed at obtaining and processing information about the undesirable consequences of the use of medicines. The objective of the paper is to identify the features of functioning of international and regional pharmacovigilance systems on the basis of the study conducted. Materials and Methods. To achieve the objective set, the authors have conducted a literature search and performed systemic analysis of the available publications and information presented on the websites of regulatory authorities in different countries. Comparative methods of analysis of the existing pharmacovigilance systems by the types of their organization and functioning in individual countries have been used with further analysis of the indicators of adverse drug reactions reporting. Results. The performed analysis of the peculiarities of functioning of pharmacovigilance systems has made it possible to identify several types of collecting information on adverse drug reactions (the centralized, decentralized, and mixed types), as well as to determine their strengths and weaknesses. It has been revealed that the maximum indicator of the average number of received spontaneous reports of adverse drug reactions per 1 million people a year was registered in countries practicing the centralized type of pharmacovigilance organization. Lower rates have been observed in countries using the decentralized or mixed pharmacovigilance systems. Discussion and Conclusion. The revealed features of the described approaches seem to be important for further improvement of the organization of work of the state system for monitoring the safety of medicines in the Russian Federation and the CIS countries. The use of the centralized type of organization of the pharmacovigilance system promotes active involvement of all actors involved in circulation of medicines, as well as helps to achieve a higher level of expert skills in assessing adverse drug reactions reporting, which contributes to the qualitative analysis of the information received and the timely adoption of regulatory decisions in order to improve safety of patients.

Introduction. Since the appearance of the immune deficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) at the beginning of 1980s, humanity started to understand elementary processes, underlying biology of HIV that enabled to develop safe and efficient treatment methods. Currently HIV therapy includes combined treatment regimen that allows combined drug interaction.Objective. To study the features of pharmacokinetics and pharmacodynamics, and also drug interaction of specific product groups, affecting human immunodeficiency virus.Materials and methods. Analytical review is based on analysis of literary sources of scientific database (PubMed, Cochrane Library, Сyberleninka) that contains information about peculiarities of pharmacokinetic and pharmacodynamic antiretroviral products’ interaction (ARVP) when used by HIV-infected patients for the period 1995–2022. Results and discussion. The current study enabled to summarize the research results, devoted to the issue of combined ARVP use by HIV-infected patients, and also to identify variants of irrational ARVP combination, caused by increased risk of toxicity with their simultaneous application.Conclusion. Studying the characteristics of each medical product, used in HIV infection therapy, allows to choose optimal pharmacotherapy regimens, taking into account individual patient characteristics, and also to predict and prevent the risk of adverse reactions in the future.

Acquired Immune Deficiency Syndrome (AIDS) is now considered one of the most global pandemics in human history. Despite the use of highly active antiretroviral therapy (HAART), HIV-1 infection is often accompanied by the development of CNS disorders, including neurocognitive disorders. The use of etiologic therapy has successfully prevented many of the possible terminal complications of the disease, but as patient survival time increases, the prevalence of cognitive impairment among AIDS patients is increasing. Theclinical manifestations of these disorders can rapidly progress from subtle attention deficits and behavioral disorders to the development of dementia. Diagnosing neurocognitive impairment in HIV-infected patients is usually difficult and requires consistent diagnostic procedures from the clinician, including initial screening and, if necessary, neuropsychiatric testing and neuroimaging. Early diagnosis and correction of neurocognitive impairment in HIV-infected individuals with adequate antiretroviral therapy is essential for successful treatment. The review also considers the use of drugs for the prevention and treatment of neurocognitive impairment, taking into account the peculiarities of persistence of the pathogen in the nervous system and the capabilities of modern medicine. One of the most promising methods of supporting therapy for such disorders is the delivery of antiretroviral drugs using various nanosystems (polymeric nanoparticles, lipid nanoparticles, nanogels, magnetic particles).

Since the beginning of the pandemic, repeated attempts have been made to develop etiotropic therapy for a novel coronavirus infection. Hydroxychloroquine, lopinavir/ritonavir, etc. derivatives were used as antiviral agents, however, they demonstrated a low efficiency and an insufficient safety. In this connection, other groups of drugs with a more effective and safe pharmacological profile are currently being actively used.The aim of the study was to analyze the literature references on the efficacy and safety of antiviral drugs for the COVID-19 treatment.Materials and methods. When searching for the materials for the review article writing, such abstract databases as PubMed, Google Scholar, e-Library were used. The search was carried out on publications for the period from January 2020 to september 2022. The key queries were: COVID-19, etiotropic therapy; immunological drugs; antiviral drugs; interferons.Results. Currently, there are various degrees of effective etiotropic drugs for the treatment of COVID-19 patients. The review has considered a few groups of drugs that are of interest from the point of view of etiotropic therapy: immunological drugs (anticovid plasma, the drugs based on antiviral antibodies, the drugs of recombinant interferons-α2 and -β1, as well as interferon inducers, i.e., the drugs based on double-stranded RNA sodium salt, and others); drugs that block the penetration of the virus into the cell (umifenovir); the drugs that disrupt the process of the viral replication (favipiravir, remdesivir, molnupiravir, nirmatrelvir/ritonavir).Conclusion. Synthetic antivirals, in particular favipiravir, molnupiravir, remdesivir, and nirmatrelvir/ritonavir, have the largest evidence base for their efficacy and safety. The search for new effective and safe etiotropic drugs for the treatment of COVID-19, as well as the collection and analysis of post-registration data on the drugs already used in clinical practice, continues.

Currently, there are data that that make it possible to speak about a high clinical efficacy of the use of succinic salt of tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine (hexapeptide succinate) for the COVID-19 treatment. This article is devoted to the results of clinical trials of the original Russian drug based on it.The aim of the study was to evaluate a clinical efficacy, safety and tolerability of intramuscular and inhalation use of hexapeptide succinate in complex therapy in comparison with standard therapy in patients with moderate COVID-19.Materials and methods. The research was conducted from February 28, 2022 to November 22, 2022 based on 10 research centers in the Russian Federation. The study included hospitalized patients (n=312) over 18 years of age with moderate COVID-19 who had undergone a screening procedure and were randomized into 3 groups: group 1 received standard therapy in accordance with the Interim Guidelines in force at the time of the study, within 10 days; group 2 received hexapeptide succinate (Ambervin® Pulmo) intramuscularly at the dose of 1 mg once a day for 10 days; group 3 received hexapeptide succinate (Ambervin® Pulmo) 10 mg once a day by inhalation for 10 days.Results. According to the results of the study, therapy with the drug hexapeptide succinate, both intramuscular and inhaled, provided an acceleration of recovery up to the complete absence of the disease signs in more than 80% of hospitalized COVID-19 patients. By the end of the therapy course with the drug, more than 60% of patients had met the criteria for discharge from hospital and could continue the treatment on an outpatient basis. About 70% of patients in the inhalation group and 80% in the intramuscular hexapeptide succinate injection group had concomitant diseases (hypertension – 28%, obesity – 14%), which indicates the effectiveness of this drug use in comorbid patients. The use of the drug contributed to the restoration of damaged lung tissues, normalization of oxygenation, the disappearance of shortness of breath and a decrease in the duration of the disease symptoms compared with standard therapy. As a result of a comparative analysis of adverse events in terms of their presence, severity, causal relationship with the therapy and outcome, there were no statistically significant differences between the treatment groups.Conclusion. Thus, the results of the clinical study of the succinate hexapeptide efficacy and safety showed the feasibility of using the drug in pathogenetic therapy COVID-19 regimens.