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1.
Modern Directed Antiviral Covid-19 Therapy: Results of Multicenter Clinical Effectiveness and Safety Study of Fixed Nirmatrelvir+Ritonavir Combination
Balykova, L. A.; Selezneva, N. M.; Gorshenina, E. I.; Shepeleva, O. I.; Kirichenko, N. V.; Simakina, E. N.; Kolontarev, K. B.; Pushkar, D. Y.; Zemskov, D. N.; Zaslavskaya, K. Y.; Noskov, S. M.; Taganov, A. V.; Bely, P. A..
Pharmacy & Pharmacology-Farmatsiya I Farmakologiya ; 10(4):371-386, 2022.
Article in Russian | Web of Science | ID: covidwho-2321846

ABSTRACT

The article presents the data from an open, two-stage, multicenter study on the efficacy and safety evaluation of a combined drug (a fixed combination of nirmatrelvir 300 mg, and ritonavir 100 mg) in the complex therapy in COVID-19 patients. The aim of the study was to assess the safety, tolerability and pharmacokinetic parameters of the fixed combination of nirmatrelvir 300 mg and ritonavir 100 mg in healthy volunteers, the efficacy and safety assessment of the drug in the combination therapy compared with the standard therapy in COVID-19 patients. Material and methods. An open two-stage multicenter clinical study to assess the main pharmacokinetic parameters, safety, and efficacy against COVID-19 of the drug nirmatrelvir 300 mg and ritonavir 100 mg combination (Skyvira((R)) PROMOMED RUS LLC, Russia) in the adult population, included 2 stages. At stage 1, safety, tolerability and pharmacokinetic parameters were evaluated in healthy volunteers (over 18 years of age) in order to confirm their comparability with the literature data known for a set of active substances. Phase 2 assessed efficacy and safety in COVID-19 patients. As a part of the second stage, the study involved 264 patients (men and women aged 18 to 80 years), who had been divided into two groups. The first group patients (n=132) received the study drugs (nirmatrelvir 300 mg and ritonavir 100 mg) - 1 tablet twice a day with an interval of 12 +/- 2 hours for 5 days in combination with pathogenetic and symptomatic therapy. The second group patients (n=132) received standard therapy in accordance with the approved Temporary Guidelines for the Prevention and Treatment of Novel Coronavirus Infection (Version 15 dated February 22, 2022). Results. During the study, none of the patients from the (nirmatrelvir + ritonavir) group experienced a transition of the COVID-19 course to a heavier severity level, in contrast to the patients in the standard therapy group. The study participants included patients with comorbidities (68% of the general population), with risk factors for COVID-19 progression to a heavier severity level and the risk of hospitalization (75% of the general population). There were no cases of COVID-19 progression to a heavier severity level in the study drug group. By the 6th day, in the nirmatrelvir + ritonavir group, the proportion of the patients who had achieved a complete recovery was twice more and amounted to 35.61% (p=0.0001), and the proportion of the patients with a negative RNA analysis to SARS-CoV-2 was 20% higher than in the comparison group, and amounted to 82.58% (p=0.0001). The fixed nirmatrelvir + ritonavir combination therapy has a favorable safety profile comparable to the standard therapy. The identified adverse reactions were transient in nature and did not require discontinuation of therapy or changes in the treatment regimen. Conclusion. The fixed nirmatrelvir + ritonavir combination has a favorable safety profile in COVID-19 patients, comparable to the standard therapy. The data obtained demonstrate a clinical and pharmacoeconomic feasibility of including the fixed (nirmatrelvir + ritonavir) combination in the COVID-19 treatment regimen.

2.
Modern Directed Antiviral Covid-19 Therapy: Results of Multicenter Clinical Effectiveness and Safety Study of Fixed Nirmatrelvir+Ritonavir Combination
Balykova, L. A.; Selezneva, N. M.; Gorshenina, E. I.; Shepeleva, O. I.; Kirichenko, N. V.; Simakina, E. N.; Kolontarev, K. B.; Pushkar, D. Yu, Zemskov, D. N.; Zaslavskaya, K. Ya, Noskov, S. M.; Taganov, A. V.; Bely, P. A..
Farmatsiya i Farmakologiya ; 10(4):371-386, 2022.
Article in English | EMBASE | ID: covidwho-2155963

ABSTRACT

The article presents the data from an open, two-stage, multicenter study on the efficacy and safety evaluation of a combined drug (a fixed combination of nirmatrelvir 300 mg and ritonavir 100 mg) in the complex therapy in COVID-19 patients. The aim of the study was to assess the safety, tolerability and pharmacokinetic parameters of the fixed combination of nirmatrelvir 300 mg and ritonavir 100 mg in healthy volunteers, the efficacy and safety assessment of the drug in the combination therapy compared with the standard therapy in COVID-19 patients. Material and methods. An open two-stage multicenter clinical study to assess the main pharmacokinetic parameters, safety, and efficacy against COVID-19 of the drug nirmatrelvir 300 mg and ritonavir 100 mg combination (Skyvira PROMOMED RUS LLC, Russia) in the adult population, included 2 stages. At stage 1, safety, tolerability and pharmacokinetic parameters were evaluated in healthy volunteers (over 18 years of age) in order to confirm their comparability with the literature data known for a set of active substances. Phase 2 assessed efficacy and safety in COVID-19 patients. As a part of the second stage, the study involved 264 patients (men and women aged 18 to 80 years), who had been divided into two groups. The first group patients (n=132) received the study drugs (nirmatrelvir 300 mg and ritonavir 100 mg) - 1 tablet twice a day with an interval of 12+/-2 hours for 5 days in combination with pathogenetic and symptomatic therapy. The second group patients (n=132) received standard therapy in accordance with the approved Temporary Guidelines for the Prevention and Treatment of Novel Coronavirus Infection (Version 15 dated February 22, 2022). Results. During the study, none of the patients from the (nirmatrelvir + ritonavir) group experienced a transition of the COVID-19 course to a heavier severity level, in contrast to the patients in the standard therapy group. The study participants included patients with comorbidities (68% of the general population), with risk factors for COVID-19 progression to a heavier severity level and the risk of hospitalization (75% of the general population). There were no cases of COVID-19 progression Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

3.
International register “dynamics analysis of comorbidities in sars-cov-2 survivors” (Aktiv sars-cov-2): Analysis of predictors of short-term adverse outcomes in covid-19
Arutyunov, G. P.; Tarlovskaya, E. I.; Arutyunov, A. G.; Belenkov, Y. N.; Konradi, A. O.; Lopatin, Y. M.; Rebrov, A. P.; Tereshchenko, S. N.; Chesnikova, A. I.; Hayrapetyan, H. G.; Babin, A. P.; Bakulin, I. G.; Bakulina, N. V.; Balykova, L. A.; Blagonravova, A. S.; Boldina, M. V.; Vaisberg, A. R.; Galyavich, A. S.; Gomonova, V. V.; Grigorieva, N. U.; Gubareva, I. V.; Demko, I. V.; Evzerikhina, A. V.; Zharkov, A. V.; Kamilova, U. K.; Kim, Z. F.; Kuznetsova, T. Yu, Lareva, N. V.; Makarova, E. V.; Malchikova, S. V.; Nedogoda, S. V.; Petrova, M. M.; Pochinka, I. G.; Protasov, K. V.; Protsenko, D. N.; Ruzanov, D. Yu, Sayganov, S. A.; Sarybaev, A. Sh, Selezneva, N. M.; Sugraliev, A. B.; Fomin, I. V.; Khlynova, O. V.; Chizhova, O. Yu, Shaposhnik, I. I.; Sсhukarev, D. A.; Abdrahmanova, A. K.; Avetisian, S. A.; Avoyan, H. G.; Azarian, K. K.; Aimakhanova, G. T.; Ayipova, D. A.; Akunov, A. Ch, Alieva, M. K.; Aparkina, A. V.; Aruslanova, O. R.; Ashina, E. Yu, Badina, O. Y.; Barisheva, O. Yu, Batchayeva, A. S.; Bitieva, A. M.; Bikhteyev, I. U.; Borodulina, N. A.; Bragin, M. V.; Budu, A. M.; Burygina, L. A.; Bykova, G. A.; Varlamova, D. D.; Vezikova, N. N.; Verbitskaya, E. A.; Vilkova, O. E.; Vinnikova, E. A.; Vustina, V. V.; Gаlova, E. A.; Genkel, V. V.; Gorshenina, E. I.; Gostishev, R. V.; Grigorieva, E. V.; Gubareva, E. Yu, Dabylova, G. M.; Demchenko, A. I.; Dolgikh, O. Yu, Duvanov, I. A.; Duyshobayev, M. Y.; Evdokimov, D. S.; Egorova, K. E.; Ermilova, A. N.; Zheldybayeva, A. E.; Zarechnova, N. V.; Ivanova, S. Yu, Ivanchenko, E. Yu, Ilina, M. V.; Kazakovtseva, M. V.; Kazymova, E. V.; Kalinina, Y. S.; Kamardina, N. A.; Karachenova, A. M.; Karetnikov, I. A.; Karoli, N. A.; Karpov, O. V.; Karsiev, M. Kh, Кaskaeva, D. S.; Kasymova, K. F.; Kerimbekova, Z. B.; Kerimova, A. Sh, Kim, E. S.; Kiseleva, N. V.; Klimenko, D. A.; Klimova, A. V.; Kovalishena, O. V.; Kolmakova, E. V.; Kolchinskaya, T. P.; Kolyadich, M. I.; Kondriakova, O. V.; Konoval, M. P.; Konstantinov, D. Yu, Konstantinova, E. A.; Kordukova, V. A.; Koroleva, E. V.; Kraposhina, A. Yu, Kriukova, T. V.; Kuznetsova, A. S.; Kuzmina, T. Y.; Kuzmichev, K. V.; Kulchoroeva, C. K.; Kuprina, T. V.; Kouranova, I. M.; Kurenkova, L. V.; Kurchugina, N. Yu, Kushubakova, N. A.; Levankova, V. I.; Levin, M. E.; Lyubavina, N. A.; Magdeyeva, N. A.; Mazalov, K. V.; Majseenko, V. I.; Makarova, A. S.; Maripov, A. M.; Marusina, A. A.; Melnikov, E. S.; Moiseenko, N. B.; Muradova, F. N.; Muradyan, R. G.; Musaelian, S. N.; Nikitina, N. M.; Ogurlieva, B. B.; Odegova, A. A.; Omarova, Y. M.; Omurzakova, N. A.; Ospanova, S. O.; Pahomova, E. V.; Petrov, L. D.; Plastinina, S. S.; Pogrebetskaya, V. A.; Polyakov, D. S.; Ponomarenko, E. V.; Popova, L. L.; Prokofeva, N. A.; Pudova, I. A.; Rakov, N. A.; Rakhimov, A. N.; Rozanova, N. A.; Serikbolkyzy, S.; Simonov, A. A.; Skachkova, V. V.; Smirnova, L. A.; Soloveva, D. V.; Soloveva, I. A.; Sokhova, F. M.; Subbotin, A. K.; Sukhomlinova, I. M.; Sushilova, A. G.; Tagayeva, D. R.; Titojkina, Y. V.; Tikhonova, E. P.; Tokmin, D. S.; Torgunakova, M. S.; Trenogina, K. V.; Trostianetckaia, N. A.; Trofimov, D. A.; Tulichev, A. A.; Tupitsin, D. I.; Tursunova, A. T.; Ulanova, N. D.; Fatenkov, O. V.; Fedorishina, O. V.; Fil, T. S.; Fomina, I. Yu, Fominova, I. S.; Frolova, I. A.; Tsvinger, S. M.; Tsoma, V. V.; Cholponbaeva, M. B.; Chudinovskikh, T. I.; Shakhgildyan, L. D.; Shevchenko, O. A.; Sheshina, T. V.; Shishkina, E. A.; Shishkov, K. Yu, Sherbakov, S. Y.; Yausheva, E. A..
Russian Journal of Cardiology ; 26(4):116-131, 2021.
Article in Russian | EMBASE | ID: covidwho-1488885

ABSTRACT

The international AKTIV register presents a detailed description of out-and inpatients with COVID-19 in the Eurasian region. It was found that hospitalized patients had more comorbidities. In addition, these patients were older and there were more men than among outpatients. Among the traditional risk factors, obesity and hypertension had a significant negative effect on prognosis, which was more significant for patients 60 years of age and older. Among comorbidities, CVDs had the maximum negative effect on prognosis, and this effect was more significant for patients 60 years of age and older. Among other comorbidities, type 2 and 1 diabetes, chronic kidney disease, chronic obstructive pulmonary disease, cancer and anemia had a negative impact on the prognosis. This effect was also more significant (with the exception of type 1 diabetes) for patients 60 years and older. The death risk in patients with COVID-19 depended on the severity and type of multimorbidity. Clusters of diseases typical for deceased patients were identified and their impact on prognosis was determined. The most unfavorable was a cluster of 4 diseases, including hypertension, coronary artery disease, heart failure, and diabetes mellitus. The data obtained should be taken into account when planning measures for prevention (vaccination priority groups), treatment and rehabilitation of COVID-19 survivors.

4.
International register “dynamics analysis of comorbidities in sars-cov-2 survivors” (Aktiv) and the register “analysis of hospitalizations of comorbid patients infected during the second wave of sars-cov-2 outbreak” (aktiv 2)
Arutyunov, G. P.; Tarlovskaya, E. I.; Arutyunov, A. G.; Belenkov, Y. N.; Konradi, A. O.; Lopatin, Y. M.; Rebrov, A. P.; Tereshchenko, S. N.; Che Snikova, A. I.; Hayrapetyan, H. G.; Babin, A. P.; Bakulin, I. G.; Bakulina, N. V.; Balykova, L. A.; Blagonravova, A. S.; Boldina, M. V.; Vaisberg, A. R.; Galyavich, A. S.; Gomonova, V. V.; Grigorieva, N. U.; Gubareva, I. V.; Demko, I. V.; Evzerikhina, A. V.; Zharkov, A. V.; Kamilova, U. K.; Kim, Z. F.; Kuznetsova, T. Yu, Lareva, N. V.; Makarova, E. V.; Malchikova, S. V.; Nedogoda, S. V.; Petrova, M. M.; Pochinka, I. G.; Protasov, K. V.; Protsenko, D. N.; Ruzanov, D. Yu, Sayganov, S. A.; Sarybaev, A. Sh, Selezneva, N. M.; Sugraliev, A. B.; Fomin, I. V.; Khlynova, O. V.; Chizhova, O. Yu, Shaposhnik, I. I.; Sсhukarev, D. A.; Abdrahmanova, A. K.; Avetisian, S. A.; Avoyan, H. G.; Azarian, K. K.; Aimakhanova, G. T.; Ayipova, D. A.; Akunov, A. Ch, Alieva, M. K.; Aparkina, A. V.; Aruslanova, O. R.; Ashina, E. Yu, Badina, O. Y.; Barisheva, O. Yu, Batchayeva, A. S.; Bitieva, A. M.; Bikhteyev, I. U.; Borodulina, N. A.; Bragin, M. V.; Budu, A. M.; Burygina, L. A.; Bykova, G. A.; Varlamova, D. D.; Vezikova, N. N.; Ver Bitskaya, E. A.; Vilkova, O. E.; Vinnikova, E. A.; Vustina, V. V.; Gаlova, E. A.; Genkel, V. V.; Gorshenina, E. I.; Gostishev, R. V.; Grigorieva, E. V.; Gubareva, E. Yu, Dabylova, G. M.; Demchenko, A. I.; Dolgikh, O. Yu, Duvanov, I. A.; Duyshobayev, M. Y.; Evdokimov, D. S.; Egorova, K. E.; Ermilova, A. N.; Zheldybayeva, A. E.; Zarechnova, N. V.; Ivanova, S. Yu, Ivanchenko, E. Yu, Ilina, M. V.; Kazakovtseva, M. V.; Kazymova, E. V.; Kalinina, Yu S.; Kamardina, N. A.; Karachenova, A. M.; Karetnikov, I. A.; Karoli, N. A.; Karpov, O. V.; Karsiev, M. Kh, Кaskaeva, D. S.; Kasymova, K. F.; Kerimbekova, Zh B.; Kerimova, A. Sh, Kim, E. S.; Kiseleva, N. V.; Klimenko, D. A.; Klimova, A. V.; Kovalishena, O. V.; Kolmakova, E. V.; Kolchinskaya, T. P.; Kolyadich, M. I.; Kondriakova, O. V.; Konoval, M. P.; Konstantinov, D. Yu, Konstantinova, E. A.; Kordukova, V. A.; Koroleva, E. V.; Kraposhina, A. Yu, Kriukova, T. V.; Kuznetsova, A. S.; Kuzmina, T. Y.; Kuzmichev, K. V.; Kulchoroeva, Ch K.; Kuprina, T. V.; Kouranova, I. M.; Kurenkova, L. V.; Kurchugina, N. Yu, Kushubakova, N. A.; Levankova, V. I.; Levin, M. E.; Lyubavina, N. A.; Magdeyeva, N. A.; Mazalov, K. V.; Majseenko, V. I.; Makarova, A. S.; Maripov, A. M.; Marusina, A. A.; Melnikov, E. S.; Moiseenko, N. B.; Muradova, F. N.; Muradyan, R. G.; Musaelian, Sh N.; Nikitina, N. M.; Ogurlieva, B. B.; Odegova, A. A.; Omarova, Yu M.; Omurzakova, N. A.; Ospanova, Sh O.; Pahomova, E. V.; Petrov, L. D.; Plastinina, S. S.; Pogrebetskaya, V. A.; Polyakov, D. S.; Ponomarenko, E. V.; Popova, L. L.; Prokofeva, N. A.; Pudova, I. A.; Rakov, N. A.; Rakhimov, A. N.; Rozanova, N. A.; Serikbolkyzy, S.; Simonov, A. A.; Skachkova, V. V.; Smirnova, L. A.; Soloveva, D. V.; Soloveva, I. A.; Sokhova, F. M.; Subbotin, A. K.; Sukhomlinova, I. M.; Sushilova, A. G.; Tagayeva, D. R.; Titojkina, Y. V.; Tikhonova, E. P.; Tokmin, D. S.; Torgunakova, M. S.; Trenogina, K. V.; Trostianetckaia, N. A.; Trofimov, D. A.; Tulichev, A. A.; Tupitsin, D. I.; Tursunova, A. T.; Tiurin, A. A.; Ulanova, N. D.; Fatenkov, O. V.; Fedorishina, O. V.; Fil, T. S.; Fomina, I. Yu, Fominova, I. S.; Frolova, I. A.; Tsvinger, S. M.; Tsoma, V. V.; Cholponbaeva, M. B.; Chudinovskikh, T. I.; Shakhgildyan, L. D.; Shevchenko, O. A.; Sheshina, T. V.; Shishkina, E. A.; Shishkov, K. Yu, Sherbakov, S. Y.; Yausheva, E. A..
Russian Journal of Cardiology ; 26(3):102-113, 2021.
Article in Russian | EMBASE | ID: covidwho-1488882

ABSTRACT

The organizer of the registers “Dynamics analysis of comorbidities in SARS-CoV-2 survivors” (AKTIV) and “Analysis of hospitalizations of comorbid patients infected during the second wave of SARS-CoV-2 outbreak” (AKTIV 2) is the Eurasian Association of Therapists (EAT). Currently, there are no clinical registries in the Eurasian region designed to collect and analyze information on long-term outcomes of COVID-19 survivors with comorbid conditions. The aim of the register is to assess the impact of a novel coronavirus infection on long-term course of chronic non-communicable diseases 3, 6, 12 months after recovery, as well as to obtain information on the effect of comorbidity on the severity of COVID-19. Analysis of hospitalized patients of a possible second wave is planned for register “AKTIV 2”. To achieve this goal, the register will include men and women over 18 years of age diagnosed with COVID-19 who are treated in a hospital or in outpatient basis. The register includes 25 centers in 5 federal districts of the Russian Federation, centers in the Republic of Armenia, the Republic of Kazakhstan, the Republic of Kyrgyzstan, the Republic of Belarus, the Republic of Moldova, and the Republic of Uzbekistan. The estimated capacity of the register is 5400 patients.

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