An observational study in Herpes, Herpes Simplex and Herpes Oral, sponsored by Nearmedic Plus LLC. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Nearmedic Plus LLC · Observational
This study examined the efficacy, safety and benefits of modern treatment and changes in the dynamics of the life of adult patients quality with severe herpes simplex in the current medical practice when combined therapy by acyclic nucleoside Valacyclovir and antiviral agent Kagocel versus monotherapy by Valacyclovir. This study also evaluated the structure of herpesvirus infections and the rate of mixed variants of the course, the rate of exacerbations of herpes simplex, the time of disappearance of human herpesvirus isolation and the features of the immune phenotype of patients taking different types of therapy.
This study was a comparative post-registration prospective non-interventional (observational) scientific study.
This research did not include any procedures or medical interventions except those recommended in the local clinical guidelines and international standards of care. All procedures and evaluations were performed in accordance with routine clinical practice adopted in the Russian Federation and the instructions for the medical use of drugs that patients received.
The following data was collected and analyzed after the end of treatment:
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 45 is below the median of 180 across 55 observational studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Nearmedic Plus LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Adult men and women with signs of severe herpes simplex.
Exclusion Criteria:
Therapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis.
Drug: Kagocel+Valacyclovir
Therapy according to routine practice. Groups will be splitted during the final data analysis.
Drug: Valacyclovir
Group 1-patients with simple severe herpes (HSV-infection orolabial and / or genital localization) treatment \[Valacyclovir + Kagocel ° \] (n= 25). Treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (the rate of suppressive therapy). \* Kagocel®, 24 mg orally (2 tablets of 12 mg): 3 times per day, 5 days continuously. \* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months
Group 2 -patients with simple severe herpes (HSV-infection orolabial and/or genital localization) receiving treatment \[Valacyclovir\] (n= 20). Scheme of treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (a course of suppressive therapy)\*. \* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months.
Change of the patients proportion with different localizations of herpes simplex exacerbations.
Time frame: 2 points: before and 6 months after the start of therapy
Change of the rate of exacerbations of orolabial, genital and other localization herpes simplex
Time frame: 2 points: before and 6 months after the start of antiviral therapy
Change of the number of patients with varying degrees of severity illness
Time frame: 2 points: before and 6 months after the start of therapy
Change in the number of local complaints (pain, itching, burning, rash) against the background of a recurrence of herpes simplex
Time frame: up to 6 months
Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)
Time frame: up to 6 (12) mounts
Change of the duration of each herpes simplex relapse and the rate of epithelialization
Time frame: 2 points: before and 6 days after the start of therapy
Change of the occurrence rate of morphological elements of the rash and General symptoms
Time frame: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change of the rate of herpes simplex rash (relapses)
Time frame: 4 points: 1 - before the start of therapy, 2 - 6 days after the start of therapy, 3 - 30 days, 4 - 4 months
Change of the intensity of herpes simplex exacerbations in points
Herpes simplex exacerbation were local symptoms (according to the patient's assessment: pain, itching, burning, rash); localization of the rash (according to the doctor's assessment: orolabial, genital, other); morphology of the rash (ulcer and / or erosion, vesicle, crust, spot); intensity of the rash (single element, several elements, multiple rashes); enlarged lymph nodes; general symptoms (weakness, drowsiness, decreased physical activity, increased body temperature). There was used subjective assessment: 1 point - min, 10 points - max intensity.
Time frame: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change in the number of herpes viruses in saliva and blood by PCR
Identification of herpes viruses type 1 and 2 (HSV1, HSV2), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpesvirus type 6 (HHV6, HHV7, HHV8) and assessment of the duration of their isolation.
Time frame: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change of antibodies titers to herpes simplex viruses type 1 and 2
Detection of specific antibodies levels against herpes simplex virus (anti-HSV-1,2 IgM, anti-HSV-1,2 IgG) using ELISA in both groups
Time frame: 2 points: before the start of therapy and on the 30th day after the start of therapy
Change of immune status parameters (flow cytometry)
Determination of changes of serum immunoglobulin levels by laser flow cytometry (g / l, UL): IgA, IgM, IgG, IgE total
Time frame: 2 points: before treatment and at 30 days after initiation of therapy
Change of immune status parameters (flow cytometry)
Detection of changes of immune status parameters by laser flow cytometry (%): CD3+, CD4+, CD8+, CD4+/CD8+, CD16+, CD19+
Time frame: 2 points: before treatment and at 30 days after initiation of therapy
Change of lymph nodes sizes (submandibular, axillary, inguinal) according to ultrasound data
Time frame: 2 points: before and 6 months after the start of therapy
The assessment of quality of life according to questionnaire
Criteria for evaluating the "Quality of life" indicator were: "excellent" - rashes and relapses of herpes simplex (HSV) are absent, physical and mental activity are above average, "good" - rare rashes of HSV (no more than 1-2 times per year), physical and mental activity are average, "satisfactory" - the rash of HSV were less likely (up to 3-4 times per year), physical and mental activity are below average, "has not changed" - the recurrence rate HSV for 6-12 months was same (as before the start of therapy and participation in the study), physical and mental activity are unsatisfactory.
Time frame: up to 6 months after initiation of therapy
Plan to share: No
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