Evaluation of the efficacy of antiviral therapy with Allokin-alpha in the combination treatment of patients with grade II HPV-associated cervical intraepithelial neoplasia

Kononova I.N., Dobrokhotova Yu.E., Kareva E.N., Shmakova N.A., Graban I.V., Ogurtsova T.A.

1) N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia, Moscow, Russia; 2) I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, Moscow, Russia; 3) “Angio Line” Medical Center, Yekaterinburg, Russia; 4) “Edelweiss” Medical Center, Yekaterinburg, Russia; 5) Yekaterinburg Clinical Perinatal Сenter, Yekaterinburg, Russia
Excisional neoplasia treatment performed during subcompensation of local immunity is not effective enough.
Preservation of a high HPV (human papillomavirus) viral load after excision and the frequent recurrence of grade II cervical intraepithelial neoplasia (CIN II) have actualized the study of the role of antiviral and immunomodulatory therapy in the combination treatment for the elimination of HPV in order to prevent recurrent cervical neoplasia.
Objectives:
1. To study the effect of Allokin-alpha on the elimination of HPV and the incidence of recurrent CIN II, to optimize the treatment of grade II neoplasia.
2. To evaluate the effect of Allokin-alpha on HPV viral load before excision.
3. To assess the feasibility of using Allokin-alpha in the combination treatment of HPV-associated CIN II, by comparing viral loads: before treatment; after therapy with the drug; after excision.
Materials and methods: An examination was made in 194 patients with HPV-associated CIN 2 verified morphopathologically and by PCR. Ninety-seven patients received immunomodulatory therapy with Allokin-alpha before excision. A control group consisted of 97 patients who underwent excision only.
Results: HPV viral loads were found to decrease by more than 2 orders of magnitude, namely, 141 times, before excision (from 5.7 lg to 3.55 lg) in 70.1% of patients who had received antiviral treatment. The use of Allokin-alpha in the combination treatment of CIN 2 increases the frequency of HPV elimination from 53.6% in the control group to 94.8% on the study one. The recurrence rate after 12 months reduced by 7.4 times in the study group compared to the control one.
Conclusion: The findings suggest that it is expedient to incorporate Allokin-alpha into the algorithms of treatment for HPV-associated CIN II at the stage of preparation for excision. Decreased viral load in patients after therapy with Allokin-alpha before excision indicates the independent efficacy of the drug against HPV.

Keywords

human papillomavirus вирус
CIN II
relapsing
immunomodulatory therapy
alloferon
Allokin-alpha

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Received 14.10.2022

Accepted 20.10.2022

About the Authors

Irina N. Kononova, Dr. Med. Sci., Department of Obstetrics and Gynecology, Pirogov Russian National Research Medical University, Ministry of Health of Russia,
+7(904)382-41-16, irkonmed@mail.ru, https://orcid.org/0000-0003-3483-9464, 1, Ostrovityanova str., Moscow, 117997, Russia.
Yuliya E. Dobrokhotova, Dr. Med. Sci., Professor, Honoured Doctor of the Russian Federation, Head of the Department of Obstetrics and Gynaecology, General Medicine Faculty, Pirogov Russian National Research Medical University, Ministry of Health of Russia, pr. dobrohotova@mail.ru, https://orcid.org/0000-0003-2786-6181,
1 Ostrovityanova str., Moscow, 117997, Russia.
Elena N. Kareva, Dr. Med. Sci., Professor at the Department of Molecular Pharmacology and Radiobiology named after Academician P.V. Sergeev, Pirogov Russian National Research Medical University, Ministry of Health of Russia; Professor at the Department of Pharmacology of the Faculty of General Medicine, I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, elenakareva@mail.ru, 1 Ostrovityanova str., Moscow, 117997, Russia.
Nadezhda A. Shmakova, obstetrician-gynecologist of the first category, MC «Angio Line», Yekaterinburg, +7(902)277-37-12, naschmakova@yandex.ru,
https://orcid.org/0000-0002-4797-3876
Irina V. Graban, obstetrician-gynecologist of the highest category, MC «Edelweiss», Yekaterinburg, а9229@yandex.ru
Tatiana A. Ogurtsova, obstetrician-gynecologist of the highest category, Yekaterinburg Сlinical Perinatal Сenter, Yekaterinburg, +7(343)304-63-32, mail@ekpc.ru,
https://orcid.org/0000-0001-6180-0288
Corresponding author: Irina N. Kononova, irkonmed@mail.ru

Authors’ contributions: All authors made significant contributions to concept development, conducting the investigation, and paper preparation. Kononova I.N. – study of literature sources, development of the design of the investigation, writing the article; Dobrokhotova Yu.E. – editing the article; Kareva E.N. – study of literature sources, substantiation of drug usage; Shmakova N.A., Graban I.V., Ogurtsova T.A. – material collection for the investigation, by distinguishing patients according to the inclusion and exclusion criteria.
Conflicts of interest. The authors declare that there are no conflicts of interest.
Funding: The investigation has not been sponsored.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Kononova I.N., Dobrokhotova Yu.E., Kareva E.N., Shmakova N.A.,
Graban I.V., Ogurtsova T.A. Evaluation of the efficacy of antiviral therapy
with Allokin-alpha in the combination treatment of patients with grade II
HPV-associated cervical intraepithelial neoplasia.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2022; 11: 155-162 (in Russian)
https://dx.doi.org/10.18565/aig.2022.11.155-162

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