List of Abbreviations
ALT – alanine aminotransferase
AST – aspartate aminotransferase
HCV – hepatitis C virus
HAV – hepatitis A virus
HBV – hepatitis B virus
WHO – World Health Organization
GGT – gamma-glutamyl transferase
CT – computed tomography
Ministry of Health of the Russian Federation – Ministry of Health of the Russian Federation
ICD-10 – International Statistical Classification of Diseases and Related Health Problems 10th Revision
AHC – acute hepatitis C
DAAs – direct-acting antivirals J05A
PT – prothrombin index
RNA – ribonucleic acid
RF – Russian Federation
ESR – erythrocyte sedimentation rate
US – ultrasound examination
EGD – esophagogastroduodenoscopy
ALP – alkaline phosphatase
CHC – chronic hepatitis C
HBcAb – antibodies to hepatitis B core antigen
HBsAg – hepatitis B surface antigen
antiHCV – antibodies to hepatitis C virus
IgG – immunoglobulin G
IgM – immunoglobulin M
Terms and Definitions
Evidence-based medicine is an approach to medical practice where decisions regarding the use of preventive, diagnostic, and therapeutic measures are made based on available evidence of their efficacy and safety, and such evidence is sought, compared, synthesized, and widely disseminated for use in the best interest of patients.
Disease – a disorder of bodily function, working capacity, and the ability to adapt to changing environmental and internal conditions arising from the impact of pathogenic factors, accompanied by alterations in the body's protective-compensatory and protective-adaptive reactions and mechanisms.
Quality of medical care – a set of characteristics reflecting the timeliness of medical care, the correctness of the choice of prevention, diagnosis, treatment, and rehabilitation methods during the provision of care, and the degree of achievement of the planned result.
Clinical guidelines – a document based on proven clinical experience that describes the physician's actions regarding the diagnosis, treatment, rehabilitation, and prevention of diseases, helping them make correct clinical decisions.
Level of certainty of evidence – reflects the degree of confidence that the found effect of a medical intervention is true.
Level of recommendation certainty – reflects not only the degree of confidence in the validity of the intervention's effect, but also the degree of confidence that following the recommendations will bring more benefit than harm in a specific situation.
Instrumental diagnostics – diagnostics using various devices, apparatuses, and instruments to examine a patient.
Laboratory diagnostics – a set of methods aimed at analyzing test material using various specialized equipment.
Medical intervention – diagnostic and/or therapeutic medical examinations and/or procedures, as well as artificial termination of pregnancy, performed by a medical professional or other employee authorized to carry out medical activities, affecting the physical or mental state of a person and having a preventive, diagnostic, therapeutic, rehabilitative, or research focus.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Acute hepatitis C (AHC) — an anthroponotic infectious disease with a blood-borne transmission mechanism of the pathogen, characterized by mild or subclinical course, with a high frequency of chronic disease development (50–80%) and the possibility of subsequent development of liver cirrhosis (LC) and hepatocellular carcinoma (HCC) in some patients [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Hepatitis C virus (HCV) was discovered in 1989 by Houghton et al.
The causative agent — hepatitis C virus (HCV) — belongs to the family Flaviviridae, genus Hepacivirus, has a spherical shape, an average diameter of 50 nm, and contains a single-stranded linear RNA molecule of 9,600 nucleotides. The nucleocapsid is surrounded by a lipid envelope and protein structures embedded in it, encoded by HCV RNA [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
The HCV genome contains two regions: one (core, E1, and E2/NS1 loci) encodes structural proteins that make up the virion (nucleocapsid, envelope proteins), while the other (NS2, NS3, NS4A, NS4B, NS5A, and NS5B loci) encodes non-structural (functional) proteins that are not part of the virion but possess enzymatic activity and are essential for viral replication (protease, helicase, RNA-dependent RNA polymerase). Structural proteins are part of the outer viral envelope and bear the virus's antigenic determinants on their surface. The viral envelope proteins are involved in the virus entering hepatocytes, as well as in the development of specific immune responses and evasion of the body's immune response to HCV infection [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
The E1 and E2/NS1 regions are characterized by high instability. Mutations occur most frequently in these loci, and they are designated as hypervariable regions 1 and 2 (HVR1, HVR2). Antibodies produced against the envelope proteins, predominantly against HVR, possess virus-neutralizing properties; however, the high heterogeneity of this locus leads to the ineffectiveness of the humoral immune response [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
Conversely, the most conservative regions are those encoding the core protein and the 5'-non-coding region (5'-UTR). The HCV genotype is determined based on genetic differences in the 5'-UTR and core region. According to the most widespread classification, there are eight HCV genotypes [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
A distinctive feature of the HCV genome structure is its high antigenic variability. The mechanisms of rapid evolution of nucleotide sequences are not fully understood. Mutations in the viral genome in the form of substitutions of individual nucleotides over time lead to the formation of a related, but heterogeneous population of isolates called quasispecies [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
Proteins E1 and E2 play a crucial role in HCV entering host cells. Receptors exist in the human body (SR-B1, DC-SIGN and L-SIGN, CD81, low-density lipoproteins, etc.) that are involved in the process of viral cell entry. After the virus attaches to the cell, its envelope fuses with the cell membrane, and the virus enters the hepatocyte via endocytosis. In the hepatocyte cytoplasm, virions undergo "uncoating," releasing the HCV positive-sense single-stranded RNA into the cytosol. HCV RNA cannot replicate in the nucleus, but it has a region through which it binds to a ribosome in the cytoplasm, and the HCV positive-sense RNA acts as a messenger RNA from which viral proteins are translated. As a result of translation on ribosomes, a polyprotein is synthesized, from which, after several cleavages by cellular and viral proteases, 10 HCV proteins are formed. These are modified into mature proteins, form a replicative complex on the endoplasmic reticulum membranes, assemble into new viral particles, and are secreted from cells via the Golgi apparatus through exocytosis. Data have been obtained indicating the possibility of extrahepatic HCV replication, for example, in peripheral blood lymphocytes. Liver cell damage is caused not only by the direct cytopathic effect of viral components or virus-specific products on cellular membranes and hepatocyte structures, but also by immunologically mediated (including autoimmune) damage directed against intracellular HCV antigens [5].
There are 8 genotypes (GT), designated by Arabic numerals from 1 to 8, and several dozen HCV subtypes designated by Latin letters. GT 1 subtypes (a and b) are of the greatest clinical significance. Genotypes and subtypes differ in sequences by approximately 30% and 20%, respectively. The variability of the viral genome causes changes in the structure of antigenic determinants that determine the production of specific antibodies. This hinders the elimination of the virus from the body and the development of an effective vaccine for the prevention of viral hepatitis [2, 3, 4, 6, 11, 16, 17, 18, 21, 23]. Compared to hepatitis A virus (HAV) and hepatitis B virus (HBV), HCV has low stability in the external environment and against physical and chemical factors. It is sensitive to chloroform, formalin, and UV irradiation; it is inactivated at 60°C within 30 minutes, and upon boiling (100°C) within 2 minutes [2, 3, 4].
1.3 Epidemiology of the Disease or Condition
The source of infection is individuals infected with HCV, including those in the incubation period. Undiagnosed individuals with an asymptomatic course of acute or chronic hepatitis are of primary epidemiological significance [1, 3, 4, 5, 7, 8, 16, 18, 23].
The mechanism of transmission of the pathogen is bloodborne (parenteral), which is realized through natural and artificial routes. The primary factor in pathogen transmission is blood or its components, and to a lesser extent, other human biological fluids (semen, vaginal secretions, tears, saliva, etc.) [1, 3, 4, 5, 7, 8, 16, 18, 23].
Artificial transmission routes are of leading epidemiological importance in acute hepatitis C (AHC); they are realized during non-medical and medical procedures accompanied by damage to the skin or mucous membranes, as well as procedures associated with the risk of such damage [1, 3, 4, 5, 7, 8, 16, 18, 23].
HCV infection during non-medical procedures accompanied by damage to the skin or mucous membranes occurs during the injection of narcotic drugs (highest risk), tattooing, piercing, ritual ceremonies, cosmetic procedures, manicures, pedicures, and other procedures using HCV-contaminated instruments [1, 3, 4, 5, 7, 8, 16, 18, 23].
During medical procedures, HCV infection is possible via blood transfusions or blood components, organ or tissue transplantation, and hemodialysis (high risk), through medical instruments for parenteral interventions, laboratory instruments, and other medical devices contaminated with HCV. HCV infection is possible during endoscopic examinations and other diagnostic and therapeutic procedures that may lead to damage to the skin or mucous membranes [1, 3, 4, 5, 7, 8, 16, 18, 23].
HCV infection can occur through contact of the mucous membrane or a wound surface with blood (its components) and other biological fluids containing HCV, as well as sexually. The sexual route of transmission is realized through heterosexual and homosexual sexual contact. The risk of HCV transmission among regular heterosexual partners when one of them has chronic hepatitis C (CHC) is low (in the absence of other risk factors). In the case of sexual transmission of HCV, there is a social pattern: homosexual men become infected in approximately 95–99% of cases, and heterosexual couples in less than 10% [1, 3, 4, 5, 7, 8, 16, 18, 23].
Transmission of the virus from an infected mother to a newborn child is possible. The probability of infection transmission from a woman infected with HCV to a newborn is low and depends on the viral load—the probability of infection increases significantly at high HCV concentrations in the mother's blood serum. HCV transmission from an infected mother to a child is possible during pregnancy and childbirth (risk 1–5%). Cases of HCV transmission from mother to child via breastfeeding have not been described [1, 3, 4, 5, 7, 8, 16, 18, 23].
In the Russian Federation, genotypes 1, 3, and 2 are prevalent in descending order of frequency. Among subtypes, 1b is more common (52.8%) than 1a (2.1%), which is similar to the European population; 3a is found in 36.3%, and genotype 2 is detected in 8.1% of cases.
According to WHO data, about 70 million people worldwide are infected with HCV; in Western European countries and the USA, hepatitis C accounts for 75–95% of post-transfusion hepatitis cases. Among patients receiving blood infusions as part of their comprehensive treatment, the highest HCV infection rate is registered in hemophilia patients at 45–80%. Official registration of acute viral hepatitis C (AHC) incidence in the Russian Federation began in 1994, with the peak incidence occurring in 2000, when the rate reached 21.1 (95% CI 20.9–21.3) per 100,000 population. During the period 2022–2023, a statistically significant increase in AHC incidence was noted to 0.75 (95% CI 0.7–0.8) and 0.95 (95% CI 0.9–1.0) per 100,000 population, respectively. In 2024, 1,445 cases of AHC were registered; the incidence reached the "pre-COVID" level and amounted to 0.99 per 100,000 population, which is 18.9% lower than the baseline incidence (1.22 per 100,000 population), but represents a 4.2% increase compared to 2023 [1, 7, 8, 23, 62, 63].
Currently, the serious problems associated with this infection are completely obvious: the high frequency of progression to chronic forms, prolonged asymptomatic course, manifestation of the disease at late stages (liver cirrhosis, LC), and a clear association with the development of hepatocellular carcinoma (HCC) [1, 3, 4, 5, 7, 8, 11, 16, 18, 23, 62, 63].
In 2016, the WHO Assembly defined a global strategy to combat viral hepatitis, aiming for the elimination of these infections by 2030. The primary goals of this program, adopted by 194 countries worldwide, are to reduce new viral hepatitis infections by 90% and deaths from the disease by 65% compared to 2016 levels. At the 2016 World Health Organization Assembly session, a target was set to provide treatment to 80% of patients by 2030 [10, 14, 15].
1.4 Features of Coding the Disease or Condition
B17.1 Acute hepatitis C.
1.5 Classification of the disease or condition
Clinical classification of acute viral hepatitis C: [2, 3, 4, 6, 11, 16, 17, 18, 21, 23].
A. By severity of clinical manifestations:
Clinical variants:
- icteric;
- anicteric;
- mild (abortive).
Subclinical (inapparent) variant.
B. Forms by degree of severity:
mild;
moderate;
severe.
C. By duration and cyclic nature of the course:
acute – up to 3 months;
protracted – 3–6 months;
with relapses, exacerbations.
If the clinical and laboratory picture of active hepatitis C virus infection persists for more than 6 months, the disease is classified as chronic hepatitis C.
1.6 Clinical presentation of the disease or condition
The incubation period for acute hepatitis C (AHC) ranges from 2 to 26 weeks (averaging 6–8 weeks). Clinical symptoms of AHC do not fundamentally differ from those of other parenteral hepatitis infections. AHC occurs in 50–80% of cases in an anicteric form, as a result of which the acute phase of the disease is rarely diagnosed [2, 3, 4, 6, 11, 16, 17, 18, 21, 23]. The anicteric variant of the disease is characterized by the same clinical and laboratory signs as the icteric variant (except for hyperbilirubinemia).
The icteric variant of HCV proceeds cyclically; the incubation period is followed by the pre-icteric period, and the course of the disease is accompanied by the development of yellowing of the skin and mucous membranes. The duration of the pre-icteric period ranges from a few days to 2 weeks; it may be absent in 20% of patients. In the pre-icteric period, asthenovegetative syndrome most frequently predominates, manifested by weakness and rapid fatigue. Dyspeptic disorders often occur: decreased appetite, discomfort in the right upper quadrant, nausea, and vomiting. Arthralgic syndrome is significantly less common, and pruritus is possible. The icteric period proceeds significantly more mildly than in other parenteral hepatitis infections [2, 3, 4, 6, 11, 16, 17, 18, 21, 23, 24].
The leading symptoms of the acute period are weakness, decreased appetite, and a sense of abdominal discomfort. Nausea and pruritus are encountered in one-third of patients, dizziness and headache in every fifth patient, and vomiting in every tenth patient. The liver is enlarged in practically all patients, and the spleen in 20% [2, 3, 4, 6, 11, 16, 17, 18, 21, 23, 24].
AHC is characterized by the same biochemical parameter changes as other parenteral hepatitis infections: elevated bilirubin levels (in the anicteric form, the bilirubin amount corresponds to normal values), and a significant increase in ALT activity (more than 10-fold). A wave-like character of hyperfermentemia is frequently noted, which is not accompanied by deterioration in well-being. In most cases, the bilirubin level normalizes by the 30th day after the onset of jaundice. Other biochemical parameters (total protein and protein fractions, prothrombin, cholesterol, alkaline phosphatase, etc.) are usually within normal limits. An increase in gamma-glutamyltransferase content is sometimes recorded. In the hemogram, there is a trend toward leukopenia, and bile pigments are detected in the urine [2, 3, 4, 6, 11, 16, 17, 18, 21, 23, 24, 31-35].
The mild variant manifests with minimal and rapidly passing clinical symptoms (including jaundice) combined with hyperfermentemia.
In the subclinical (inapparent) variant, unlike the anicteric and mild variants, the well-being of the patients is not impaired at all, the liver is not enlarged, jaundice does not appear, but ALT and AST activity indices are elevated, and specific HCV markers are determined in the blood serum.
AHC predominantly runs a moderate course, and in 30% of patients, a mild course. A severe course of the disease is possible (rarely), and fulminant AHC leading to a fatal outcome is recorded very rarely, predominantly among individuals with chronic hepatitis B [2, 3, 4, 6, 11, 16, 17, 18, 21, 23, 24].
In the natural course, 20–50% of AHC patients spontaneously recover, while the rest develop chronic hepatitis C (CHC). Spontaneous recovery can be stated if a patient who has not received specific antiviral therapy, against the background of good well-being and normal liver and spleen dimensions, demonstrates normal blood biochemical parameters, and HCV RNA is not detected in the blood serum for at least 2 years after AHC [19, 30].
In 50–80% of individuals who have undergone the acute form of the disease, chronic hepatitis develops, which is the most widespread pathology among chronic viral liver lesions. The development of CHC may be accompanied by the normalization of clinical and biochemical parameters following the acute period, but subsequently, hyperfermentemia and HCV RNA reappear in the blood serum [2, 3, 4, 6, 11, 16, 17, 18, 21, 23, 24].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for diagnosing the disease/condition:
Acute hepatitis C is diagnosed based on: [3, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
duration of infection (less than 6 months); (information on the absence of anti-HCV antibodies within the specified periods acts as a "baseline point");
epidemiological history data on events that occurred within periods corresponding to the incubation period (presence of medical and non-medical parenteral manipulations accompanied by disruption of the integrity of the skin and mucous membranes, including intravenous administration of psychoactive drugs), blood transfusion or its components; sexual contacts (significantly less frequently than with hepatitis B);
clinical picture (duration of the pre-icteric period 1–2 weeks), however, jaundice does not develop in 80% of AHC cases; the disease is characterized by a gradual onset, may be accompanied by asthenovegetative syndrome, weakness, rapid fatigue, dyspeptic disorders in the form of decreased appetite, discomfort in the right upper quadrant, nausea, and vomiting; arthralgia and exanthema, unlike acute hepatitis B, are significantly less common, and short-term subfebrile temperature is possible; moderate enlargement of the liver dimensions, having an elastic consistency, sensitive upon palpation, less frequently splenomegaly; (has low diagnostic value in the differential diagnosis of acute and chronic hepatitis C);
laboratory data: detection of HCV RNA and absence of anti-HCV antibodies in a patient with the clinical presentation of acute hepatitis with subsequent seroconversion, which is the most important diagnostic criterion for AHC. In the blood of AHC patients, in most cases, only HCV RNA is detected first, then an elevated level of ALT activity, and only after a certain period do anti-HCV antibodies appear. Based on the presence of the "serological window", patients with the clinical presentation of acute hepatitis should immediately undergo blood testing for HCV RNA and anti-HCV.
2.1 Complaints and Anamnesis
It is recommended to pay attention to various parenteral interventions and manipulations, blood or blood component transfusions, surgeries, tattoos, piercings, etc.; casual sexual contacts or frequent change of sexual partners, as well as contact with hepatitis C patients during the last 6 months before the onset of disease symptoms in all patients with suspected AHC, in order to identify the source and transmission factors of the infection [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to pay attention to general malaise, fever, fatigue, anorexia, nausea, vomiting, the appearance of jaundice and/or dark urine, acholic stool in all patients with suspected AHC for clinical diagnosis [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to pay attention to cohabitation with a person infected with HCV and sexual relations with a person having an acute or chronic HCV infection in all patients with suspected AHC in order to identify the source and transmission factors of the infection [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
2.2 Physical Examination
It is recommended for patients with suspected acute viral hepatitis C to start with a general examination to detect the presence of icteric staining of the skin and mucous membranes [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to perform abdominal palpation determining the dimensions (enlargement or reduction) and consistency of the liver and spleen in patients with AHC to diagnose hepatosplenomegaly syndrome [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
2.3 Laboratory Diagnostics
At the diagnostic stage
It is recommended for patients with suspected AHC to perform a complete (clinical) blood count for the diagnosis of AHC, timely detection of complications, and emergency conditions in the comprehensive assessment of disease severity [30, 31-35].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: uncomplicated acute hepatitis C is characterized by leukopenia, neutropenia, thrombocytopenia, and increased ESR in the pre-icteric period; anemia is rare. Fulminant or complicated forms present with leukocytosis, neutrophilia, a left shift in the leukocyte formula, thrombocytopenia, and decreased ESR.
Recommended for patients with suspected acute hepatitis C to undergo a general (clinical) urine test to detect signs of impaired pigment metabolism and concomitant urinary tract bacterial infection [30, 31-35].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: changes in urine color, elevated urobilinogen, and bile pigments are typical. Detection of urobilin and bile pigments in the urine is possible as early as the pre-icteric period.
Recommended for patients with suspected acute hepatitis C to undergo a general general-medical biochemical blood test: testing for total bilirubin and its fractions in the blood, determining the activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and blood cholesterol levels to assess the presence and activity of cytolysis and cholestasis syndromes [32-35].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: performed to assess baseline parameter levels; an increase in ALT, AST, ALP, and GGT activity is typical.
Recommended for patients with acute hepatitis C showing signs of complications such as hemorrhagic syndrome to undergo a coagulogram (exploratory hemostasis study), including non-activated clotting time of unstabilized blood, non-activated plasma recalcification time, or plasma recalcification time, bleeding time, prothrombin (thromboplastin) time in blood or plasma, thrombin time in blood, and prothrombin index (PTI) to provide timely medical care [32-35, 57, 58].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: demonstrates decreased fibrinogen, decreased prothrombin time, prolonged blood clotting time, and a decreased PTI.
Recommended for patients with suspected acute hepatitis C to undergo testing for class G antibodies (anti-HCV IgG) to hepatitis C virus (Hepatitis C virus) in the blood to confirm the etiological factor of the disease [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Not recommended to use testing for class M antibodies (anti-HCV IgM) to hepatitis C virus (Hepatitis C virus) in the blood as a marker of the acute phase of HCV [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: diagnosis is performed using screening and confirmatory reagent kits. Detection of IgM anti-HCV as a marker of acute infection is uninformative, as antibodies of this class may be absent or may be detected in chronic hepatitis C [6, 8, 9, 21, 34]. In addition, anti-HCV can circulate in isolation in the blood of patients who have recovered from acute hepatitis C or are in remission following the elimination of HCV RNA as a result of antiviral therapy. Of particular diagnostic value for establishing a diagnosis of acute hepatitis C is the detection of anti-HCV in disease dynamics when early tests were negative [6, 8, 21].
Recommended qualitative testing for hepatitis C virus (Hepatitis C virus) RNA in the blood by PCR for patients with HCVAb and in case of clinical and epidemiological suspicion of acute hepatitis C, regardless of the presence of HCVAb, to determine viremia [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Recommended hepatitis C virus (Hepatitis C virus) genotyping for patients with confirmed viremia to select a medicinal product when planning the use of J05AP antiviral drugs for hepatitis C treatment that depend on the viral genotype [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: when using genotype-independent J05AP antiviral drugs for hepatitis C treatment, this test is not performed.
Recommended serological testing: hepatitis B virus (Hepatitis B virus) surface antigen (HBsAg) in the blood, hepatitis B virus (Hepatitis B virus) core antibody IgM (anti-HBc IgM), hepatitis A virus (Hepatitis A virus) class M antibodies (anti-HAV IgM) in the blood, and hepatitis E virus (Hepatitis E virus) class M antibodies (anti-HEV IgM) in the blood for all patients with suspected acute hepatitis for differential diagnosis with other viral hepatitides and to identify mixed infection [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Recommended determination of ABO blood groups and Rhesus D antigen (Rh factor) for patients with a severe and complicated course of the disease for potential emergency care [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GGR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
During antiviral therapy (AVT):
Recommended general-medical biochemical blood test: testing for total bilirubin and its fractions, and determining the activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT) in the blood for patients with acute hepatitis C after two and four weeks of AVT, at the end of the treatment course, and at 12 and 24 weeks after the completion of treatment for dynamic monitoring of therapy efficacy and safety [3, 4, 6, 9, 10, 16, 17, 18, 20, 21, 23, 24, 25, 26, 28, 29, 34, 35, 43-49].
GGR CLeE 5Grade of Recommendation C (Level of Evidence – 5)
Comments: if adverse events develop, laboratory tests are performed more frequently according to clinical indications. In the presence of renal impairment with reduced creatinine clearance, renal function must be monitored monthly during sofosbuvir-containing treatment regimens.
At the evaluation stage after completion of AVT (sustained virological response at 3 months)
Recommended general-medical biochemical blood test: testing for total bilirubin and its fractions, and determining the activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the blood for patients with acute hepatitis C who have completed AVT to confirm treatment efficacy [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GGR CLeE 5Grade of Recommendation C (Level of Evidence – 5)
Comments: performed for dynamic monitoring of the efficacy of the administered therapy (reduction in the severity of cytolysis and cholestasis syndromes, improvement in hepatic synthetic function). A protein profile is performed if concomitant liver cirrhosis is present.
Recommended qualitative testing for hepatitis C virus (Hepatitis C virus) RNA in the blood by PCR for patients who have completed AVT to confirm treatment efficacy at 12 or 24 weeks after the end of therapy (SVR12/24) [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34-37, 43].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
If qualitative testing for hepatitis C virus (Hepatitis C virus) RNA in the blood by PCR is not feasible, recommended testing for hepatitis C virus (Hepatitis C virus) Core antigen in the blood for patients receiving AVT to assess treatment efficacy [3, 4, 6, 9, 10, 16, 17, 18, 20, 21, 23, 24, 25, 26, 28, 29, 34-37, 43-49].
SOR CLOE 5Strength of recommendation C (level of evidence – 5)
At the stage of pathogenetic and symptomatic therapy
Recommended general (clinical) blood test with differential leukocyte count and platelet count for all patients with acute hepatitis C for dynamic evaluation to detect complications and concomitant pathology [31-35].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Recommended general-medical biochemical blood test: testing for total bilirubin and its fractions, determining the activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), and prothrombin index (PTI) in the blood for all patients with acute hepatitis C for dynamic monitoring of parameters [32-35].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: performed at intervals of 7-10 days. If clinically indicated, the frequency of testing is at the discretion of the attending physician.
2.4 Instrumental Diagnostics
Recommended for patients with acute hepatitis C to undergo complex abdominal ultrasound to diagnose hepatomegaly and structural liver changes, splenomegaly, and to rule out concomitant gastrointestinal pathology [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: hepatomegaly without structural liver changes is typical; splenomegaly is possible [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
It is recommended to perform computed tomography or magnetic resonance imaging of the abdominal organs in patients with unclear focal changes in the liver and spleen, or with uncertain or contradictory data obtained from abdominal ultrasound, in order to clarify the pathology [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to register an electrocardiogram (ECG) in patients with any cardiovascular abnormalities (cardiac arrhythmias, changes in heart borders and sounds, heart murmurs) in order to detect and prevent the development of decompensation of comorbid conditions [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: patients in the acute period are characterized by a tendency to bradycardia, while upon clinical deterioration, increasing intoxication, and the risk of precoma, prognostically unfavorable signs include changes in heart rhythm, the onset of tachycardia, and muffled heart sounds [3, 9, 13].
It is recommended to perform esophagogastroduodenoscopy in patients with abdominal pain and coffee-ground vomiting to determine the nature of lesions in the mucosa of the esophagus, stomach, and duodenum [3, 4, 6, 9, 10, 16, 17, 18, 21, 23, 24, 28, 29, 34, 35, 43].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
2.5 Other Procedures
It is recommended in the presence of emergency conditions in patients with severe and complicated acute viral hepatitis (AVH) and concomitant pathology, to conduct an initial consultation by an anesthesiologist-resuscitator to determine indications for transfer to the intensive care unit (ICU) [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to conduct an initial examination (consultation) by a surgeon in patients with AVH presenting with intense abdominal pain, hypotension, and hemorrhagic syndrome to rule out acute surgical pathology and determine indications for transfer to the surgical department [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Treatment of patients with AVH aims to prevent the progression of the pathological process caused by HCV.
Given the high efficacy of antiviral therapy (AVT) for AVH, the choice of the AVT regimen should be based on a balanced analysis of the safety of the treatment regimen and the economic feasibility of using a particular treatment scheme.
3.1 Conservative Treatment
3.1.1 Etiotropic (antiviral) therapy
It is recommended to administer antiviral therapy with direct-acting antiviral agents (DAAs) belonging to J05A to patients with AVH and confirmed viremia for virus eradication [10, 11, 13, 14, 15, 20, 23, 25, 26, 29, 44-49, 52].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: initiation of antiviral therapy regardless of the stage of medical care. Treatment started in a timely manner is accompanied by the achievement of sustained virologic response (SVR) in more than 90% of AVH patients. Treatment initiation should not be delayed waiting for "spontaneous" HCV clearance. Recent data show that treating patients with acute HCV infection using modern DAAs is effective, safe, and cost-effective (economically justified), whereas refusing early therapy increases the risk of HCV transmission and spread.
It is recommended to treat patients with AVH using DAAs according to one of the alternative regimens [10, 11, 14, 15, 23, 25, 26, 42-49, 52].
- #Velpatasvir + Sofosbuvir** (sofosbuvir 400 mg and velpatasvir 100 mg orally 1 tablet once daily regardless of food intake (for all genotypes)) for 8 weeks and for 12 weeks in protracted cases [10, 14, 15, 42, 55].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
- #Glecaprevir + Pibrentasvir** (glecaprevir 100 mg and pibrentasvir 40 mg in a tablet (for all genotypes — 3 tablets once daily)) for 8 weeks [10, 14, 15, 56, 64, 65].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
- #Grazoprevir + Elbasvir** (grazoprevir 100 mg and elbasvir 50 mg (for genotypes 1b and 4) once daily regardless of food intake for 8 weeks [10, 14, 15, 41].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
- #Ledipasvir + Sofosbuvir (sofosbuvir 400 mg and ledipasvir 90 mg once daily, regardless of food intake (for genotypes 1, 4, 5, 6)) [10, 14, 15, 45, 46, 50, 51, 53, 54].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
- #Daclatasvir** + Sofosbuvir** (daclatasvir** 60 mg 1 tab. once daily + sofosbuvir** 400 mg 1 tab. once daily; (for genotypes 1, 2, 3, 4, 5, 6) for 12 weeks [66, 67].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: treatment regimens for patients with acute hepatitis C are the same as for patients with chronic hepatitis C, while the duration of treatment should be at least 8 weeks. The probability of achieving SVR when using DAAs is more than 90%.
It is recommended to take into account the severity of liver and kidney damage when prescribing DAAs to AVH patients to identify contraindications to the drugs [7, 13, 14, 20, 21, 26].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: antiviral drugs for the treatment of HCV infection whose mechanism of action belongs to NS3/4A protease inhibitors should not be used in AVH patients with decompensated cirrhosis of the liver of any other etiology (alcoholic, HBV, etc.); in patients with severe renal impairment with a glomerular filtration rate < 30 mL/min/1.73 m2, sofosbuvir-containing regimens should be used only if there is no alternative treatment approved for use in patients with existing severe renal impairment.
Every patient must be informed about the importance of adherence to therapy and strict compliance with the dosage instructions. While undergoing DAA treatment, the patient must inform the doctor about all medications prescribed by other specialists for other reasons, as there is a risk of undesirable drug-drug interactions.
3.1.2 Pathogenetic and symptomatic therapy
It is recommended to mandatory carry out basic therapy in patients with AVH regardless of the severity of the disease in order to restore impaired liver functions and prevent complications [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: basic therapy includes a restrictive regimen and a diet that is gentle on culinary processing and excludes irritating substances. Spicy, fried, smoked, and marinated dishes, refractory fats (pork, mutton), etc., are excluded from the diet. Alcohol in any form is strictly prohibited.
It is recommended to conduct detoxification therapy in patients with AVH in the presence of intoxication, taking into account the severity of the disease to relieve intoxication syndrome: mild form of the disease — oral detoxification with 2–3 liters of fluid per day (weakly brewed tea with milk, honey, jam, rosehip decoction, compotes, alkaline mineral waters).
Moderate severity — infusion therapy: 800–1200 mL of 5% dextrose** solution intravenously drip, meglumine sodium succinate** at a rate of up to 90 drops/min (1–4.5 mL/min) — 400–800 mL/day (average daily dose is 10 mL/kg. Course of therapy — up to 11 days. Volume and duration depend on the patient's severity) [60, 61].
Severe severity — intensification of detoxification therapy by administering dextran**, 10% albumin** solution, blood plasma [3, 6, 9, 16, 17, 18, 21, 23, 60, 61].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to perform extracorporeal detoxification (plasmapheresis, plasmapheresis with partial plasma exchange, hemosorption, hemodialysis) in patients with severe and complicated forms of AVH in cases of ineffective detoxification therapy [6, 9, 16, 17, 18, 23, 68].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to use hemostatic agents: 5% aminocaproic acid** solution at a dose of 200 mL twice daily in patients with hemorrhagic syndrome to correct hemostasis [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments:
It is recommended to prescribe amino acids and their derivatives and other drugs for the treatment of liver diseases to patients regardless of the severity form:
in case of intrahepatic cholestasis development — ademetionine** — dose 5–12 mg/kg/day intravenously or intramuscularly. If maintenance therapy is necessary, continue taking the drug in tablet form at a dose of 800–1600 mg/day for 2–4 weeks.
- glycyrrhizic acid + phospholipids** — lyophilizate for solution for intravenous administration 2500 mg, previously dissolved in 10 mL of water for injections**, IV bolus slowly 2 times a day for 10 days, then switch to oral administration of 1–2 capsules 3 times a day orally with meals, inosine 0.6–0.8 g 3–4 times a day. Duration of the course of oral drugs with hepatoprotective and antioxidant action is 3–4 weeks and up to 6 months to improve tissue metabolism and stabilize cell membranes [3, 6, 9, 16, 17, 18, 21, 23, 38, 39, 40, 59].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to prescribe papaverine and its derivatives: drotaverine** — 40–80 mg 1–2 times a day, papaverine orally — 40–60 mg 3–5 times/day — to patients complaining of aching pain in the right hypochondrium caused by spasms of the biliary smooth muscles and upon the development of cholestasis to improve bile outflow [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to prescribe vitamins to patients regardless of the form and severity of the disease: parenteral administration of ascorbic acid**, B vitamins (pyridoxine**, thiamine**), nicotinic acid and its derivatives. Oral administration of retinol** and alpha-tocopherol acetate is possible only in the absence of cholestasis syndrome to meet the daily requirement [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: vitamin requirements must be met both through natural foods and the additional prescription of multivitamins.
It is recommended for all patients with viral hepatitis to undergo therapy aimed at normalizing gastrointestinal tract function (preventing constipation, combating dysfunction) to ensure daily bowel movements for the elimination of toxic substances: depending on clinical symptoms, both gastrointestinal motility stimulants and laxatives are used (lactulose** - initial daily dose 15-45 ml, maintenance daily dose 15-30 ml, domperidone 10-20 mg 2 times a day orally, metoclopramide** 20 mg 1-3 times a day orally for nausea, vomiting, gastroesophageal reflux, flatulence) as well as intestinal adsorbents A07B (dioctahedral smectite** 1 sachet 3 times a day, dissolving its contents in 1/2 cup of water, colloidal silicon dioxide – average daily dose in adults 0.1-0.2 g per 1 kg of body weight (6-12 g), taken 3-4 times a day, dissolved in 1/4-1/2 cup of water). The course duration is 3-5 days; when treating patients with acute viral hepatitis C, it is necessary to monitor daily bowel movements; the dose of lactulose** and other laxatives should be selected individually so that the stool is daily, formed, or mushy [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended for patients with symptoms of pancreatic damage to prescribe enzyme preparations as replacement therapy with the goal: pancreatin** 25 IU, 2-4 tablets orally 3 times a day during meals, course duration 10-15 days. The maximum daily dose is 16 tablets [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to use ibuprofen** - tablets 200 mg 3-4 times a day (maximum daily dose 1200 mg; to achieve a faster therapeutic effect in adults, a single dose can be increased to 400 mg 3 times a day) in patients with manifestations of fever syndrome in order to relieve it [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Antibacterial therapy is recommended for patients with concomitant bacterial infections and associated diseases (cholecystitis, cholangitis, pneumonia, etc.): other beta-lactam antibacterial drugs (cefazolin** or ceftriaxone** at a dose of 1000 mg 2 times a day intramuscularly), metronidazole** 500 mg 3 times a day orally. Course duration 10-14 days. The preferred option is the prescription of metronidazole** for the sanitation of bacterial infection foci [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: with pronounced cholestatic syndrome and prolonged hyperbilirubinemia, biliary tract lesions (cholangitis, cholecystitis, pericholecystitis) always occur, requiring antibacterial therapy.
3.2 Surgical Treatment
Liver transplantation is recommended for patients with a fulminant course of acute viral hepatitis C to improve their survival [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: acute liver failure in acute viral hepatitis C is very rare (< 1%).
3.3 Other Treatment
Not applicable.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
It is recommended to start rehabilitation measures already during the peak period or early convalescence period in all patients with acute viral hepatitis C [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to ensure a comprehensive nature of rehabilitation measures involving various specialists and utilizing a variety of intervention methods for all patients with acute viral hepatitis C [3, 6, 9, 16, 17, 18, 21, 23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended to observe consistency and continuity of the measures carried out, ensuring continuity at various stages of rehabilitation and follow-up (dispensary observation) for all patients with acute viral hepatitis C [3, 6, 9, 16, 17, 18, 21, 23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended that rehabilitation and recovery measures and interventions be adequate to the adaptive and reserve capabilities of the patient with acute viral hepatitis C [3, 6, 9, 16, 17, 18, 21, 23].
GGR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: gradual increase in metered physical and mental stress, as well as differentiated application of various intervention methods, is important.
It is recommended to continuously monitor the effectiveness of the measures carried out in all patients with acute viral hepatitis C [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: the speed and degree of recovery of the functional state and professionally significant functions of convalescents are taken into account (using indirect and direct methods).
5. Prevention and Dispensary Observation
5.1 Prevention
5.1.1 Specific prevention
Specific prophylaxis for viral hepatitis C has not been developed to date [3, 6, 9, 16, 17, 18, 21, 23].
5.1.2 Nonspecific prevention
It is recommended to actively identify sources of infection (screening individuals at high risk of infection and/or of particular epidemiological significance) [3, 6, 9, 16, 17, 18, 21, 23].
GorC CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended to prevent artificial transmission mechanisms (blood transfusion only for vital indications, justification of invasive diagnostic methods, use of disposable instruments, strict adherence to processing regimens for medical instruments and equipment, use of protective equipment by medical personnel, etc.) [3, 6, 9, 16, 17, 18, 21, 23].
GorC CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended to treat patients with acute and chronic forms of viral hepatitis C aimed at complete eradication of the pathogen to prevent the spread of infection [3, 6, 9, 16, 17, 18, 21, 23].
GorC CLEL 5Grade of Recommendation C (Level of Evidence – 5)
5.2 Dispensary monitoring
It is recommended to conduct dispensary observation of acute viral hepatitis C convalescents for 6 months to assess the effectiveness of antiviral therapy and determine the outcome of the disease (recovery – elimination of hepatitis C virus from the body or transition to a chronic form) [3, 6, 9, 16, 17, 18, 21, 23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: if the patient was discharged with a significant increase in aminotransferase activity, an examination is performed 14 days after discharge.
It is recommended for patients who have undergone acute viral hepatitis C to determine hepatitis C virus (Hepatitis C virus) RNA in the blood by PCR (qualitative assay) 6 months after disease detection [3, 6, 9, 16, 17, 18, 21, 23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: if HCV RNA is detected, these individuals are considered to have chronic hepatitis C and are subject to further dispensary observation. If HCV RNA is not detected after 6 months, these individuals are considered convalescents of acute viral hepatitis C.
All patients after discharge from the hospital are recommended to refrain from routine vaccinations for 6 months, except (if indicated) tetanus toxoid** and rabies vaccine** [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
All patients for half a year after recovering from acute viral hepatitis C are recommended to refrain from taking hepatotoxic drugs and alcohol [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
6. Organization of Medical Care
It is recommended to hospitalize patients with acute viral hepatitis C in a medical organization based on clinical and epidemiological indications: severe and moderate course, suspicion of acute hepatic encephalopathy, risk of fulminant hepatitis, presence of severe comorbidities (diabetes mellitus, mixed infection with hepatotropic viruses and human immunodeficiency virus), pregnancy, or inability to ensure isolation at home [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: during inpatient treatment, hepatitis C patients are placed separately from patients with viral hepatitis A and E, as well as patients with unspecified forms of hepatitis.
Discharge of patients with acute viral hepatitis C from the hospital is recommended based on clinical and laboratory indicators: decrease in alanine aminotransferase activity to less than 150 IU/L, decrease in bilirubin level to 40 µmol/L or less, prothrombin index increase of at least 80% and above [3, 6, 9, 16, 17, 18, 21, 23].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Medical care is provided in the form of:
o emergency medical care;
o urgent medical care;
o elective medical care.
Conditions for the provision of medical services
Medical care is provided in the form of:
o primary health care;
o emergency medical care, including specialized emergency medical care;
o specialized medical care, including high-tech medical care.
Medical care for adult patients with acute viral hepatitis C can be provided in the following settings:
o outpatiently (in conditions not providing around-the-clock medical monitoring and treatment);
o in a day hospital (in conditions providing medical monitoring and treatment during the day, not requiring around-the-clock medical monitoring and treatment);
o inpatiently (in conditions providing around-the-clock medical monitoring and treatment).
Primary health care is provided to patients on an outpatient basis and in a day hospital setting.
Primary paramedic-led health-care in outpatient settings is provided at feldsher-midwifery stations.
Primary physician-delivered health care is provided by a district general practitioner or general practitioner (family doctor) on an outpatient basis.
Primary specialized primary health care is provided by an infectious disease specialist of a medical organization providing medical care to outpatients.
Specialized, including high-tech, medical care is provided in an inpatient setting by infectious disease specialists and other medical specialists and includes the prevention, diagnosis, and treatment of diseases and conditions requiring the use of special methods and complex medical technologies, as well as medical rehabilitation.
Treatment of patients is carried out in a hospital setting upon referral by a general practitioner (district physician), general practitioner (family physician), infectious disease specialist, or medical workers who have detected acute viral hepatitis.
7. Additional Information
A number of factors have been identified that can have a negative impact on the natural course of hepatitis C: age over 40 years at the time of infection, male sex, non-Caucasian race, alcohol abuse, obesity, iron metabolism disorders, metabolic syndrome, etc. [3, 6, 9, 16, 17, 18, 21, 23]:
Factors the presence of which increases the risk of liver failure and death [3, 6, 9, 16, 17, 18, 21, 23]:
mixed infection with hepatotropic viruses and human immunodeficiency virus;
severe somatic pathology;
alcoholism, drug addiction, and substance abuse.
Criteria for Evaluating the Quality of Medical Care
References
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Appendix A1. Working Group Composition
Gorelov A.V. – Academician of the Russian Academy of Sciences, Professor, Deputy Director for Scientific Work at the Central Research Institute of Epidemiology of Rospotrebnadzor, Head of the Department of Infectious Diseases and Epidemiology at the A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Russian Ministry of Health.
Gusev D.A. – Doctor of Medical Sciences, Professor, Chief Physician of the S.P. Botkin Clinical Infectious Diseases Hospital, Head of the Department of Infectious Diseases at the Institute of Medical Education of the V.A. Almazov National Medical Research Centre.
Novak K.E. – PhD in Medical Sciences, Associate Professor, Associate Professor at the Department of Adult Infectious Diseases and Epidemiology at the St. Petersburg State Pediatric Medical University of the Russian Ministry of Health.
Sagalova O.I. – Doctor of Medical Sciences, Professor, Head of the Infectious Diseases Department at the Clinic of the South Ural State Medical University of the Russian Ministry of Health.
Usenko D.V. – Doctor of Medical Sciences, Head of the Educational Center, Leading Researcher at the Clinical Department of Infectious Pathology at the Central Research Institute of Epidemiology of Rospotrebnadzor.
Chulanov V.P. – Doctor of Medical Sciences, Professor, Deputy Director for Scientific Work and Innovative Development at the National Medical Research Center for Phthisiopulmonology and Infectious Diseases of the Russian Ministry of Health.
Esaulenko E.V. – Doctor of Medical Sciences, Professor, Head of the Department of Adult Infectious Diseases and Epidemiology at the St. Petersburg State Pediatric Medical University of the Russian Ministry of Health.
All members of the working group are members of the Pokrovsky National Association of Infectious Disease Specialists (NAIDS).
There is no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience of the clinical guidelines:
Infectious disease specialist;
General practitioner (internist);
Gastroenterologist;
General practitioner;
Medical students, residents, postgraduate students.
In these clinical guidelines, all information is ranked by the level of reliability (evidence) depending on the quantity and quality of studies on the issue.
Table 1. Scale for assessing the levels of evidence (LE) for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for assessing the levels of evidence (LE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Rating scale for grades of recommendation (GR) for preventive, diagnostic, therapeutic, and rehabilitation methods (interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
These clinical guidelines were developed taking into account the following regulatory legal documents:
Federal Law No. 157-FZ dated September 17, 1998 (as amended on December 25, 2023) "On Immunoprophylaxis of Infectious Diseases".
Federal Law of the Russian Federation No. 326-FZ dated November 29, 2010 "On Compulsory Medical Insurance in the Russian Federation".
Federal Law No. 323-FZ dated November 21, 2011 "The Fundamentals of Healthcare Protection in the Russian Federation".
Order of the Ministry of Health and Social Development of the Russian Federation No. 494 dated August 9, 2005, "On the Procedure for the Use of Medicinal Products in Patients for Vital Indications".
Order of the Russian Ministry of Health No. 804n dated October 13, 2017 (as amended on September 24, 2020, with amendments dated October 26, 2022) "On Approval of the Nomenclature of Medical Services" (Registered with the Ministry of Justice of Russia on November 7, 2017, No. 48808).
Order of the Russian Ministry of Health No. 205n dated May 2, 2023, "On the Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers".
Order of the Russian Ministry of Health No. 700n dated October 7, 2015 (as amended on December 9, 2019) "On the Nomenclature of Specialties of Specialists with Higher Medical and Pharmaceutical Education" (Registered with the Ministry of Justice of Russia on November 12, 2015, No. 39696).
Order of the Ministry of Labor of Russia No. 374n dated July 26, 2024, "On Approval of Classifications and Criteria Used in Carrying Out Medical and Social Expertise of Citizens by Federal Medical and Social Expertise Institutions".
Federal Law No. 52-FZ dated March 30, 1999 (as amended on July 31, 2025) "On the Sanitary and Epidemiological Welfare of the Population"
Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 12 dated June 25, 2025, "On Amending the Sanitary Rules and Norms SanPiN 3.3686-21 'Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases', approved by the Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 4 dated January 28, 2021".
Order of the Russian Ministry of Health No. 330 dated August 5, 2003 (as amended on February 19, 2024) "On Measures to Improve Therapeutic Nutrition in Healthcare Institutions of the Russian Federation" (along with the "Regulation on the Organization of Activities of a Dietitian", "Regulation on the Organization of Activities of a Dietary Nurse", "Regulation on the Council for Therapeutic Nutrition of Healthcare Institutions", "Instructions on the Organization of Therapeutic Nutrition in Healthcare Institutions") (Registered with the Ministry of Justice of Russia on September 12, 2003, No. 5073).
Order of the Russian Ministry of Health No. 395n dated June 21, 2013 (as amended on February 19, 2024) "On Approval of Therapeutic Nutrition Standards" (Registered with the Ministry of Justice of Russia on July 5, 2013, No. 28995).
Order of the Ministry of Health of the Russian Federation No. 1008n dated September 23, 2020, "On approval of the procedure for providing patients with therapeutic nutrition".
Monitoring schedule for laboratory parameters during direct-acting antiviral therapy (DAA)
Parameters | DAA weeks | ||||
|---|---|---|---|---|---|
DAA baseline | 2 | 4 | 8/end of treatment | ||
Complete blood count (CBC) with differential | + | + | + | + | |
General clinical blood chemistry test | Total bilirubin | + | + | + | + |
Bilirubin fractions | + | + | + | ||
ALT | + | + | + | + | |
AST | + | + | + | + | |
ALP | + | + | + | + | |
GGT | + | + | + | + | |
Urea | + | + | + | ||
Creatinine | + | + | + | + | |
Glucose | + | ||||
Total protein | + | + | + | ||
Albumin | + | + | + | + | |
Prothrombin index | + | + | + | + | |
Qualitative PCR determination of hepatitis C virus RNA (Hepatitis C virus) in blood | Qualitative assay | + | + | ||
Determination of hepatitis C virus genotype in patients with confirmed viremia to select a medicinal product when planning the use of J05AP genotype-dependent antiviral drugs for the treatment of hepatitis C | + | ||||
Criteria for assessing the severity of viral hepatitis C based on clinical and laboratory diagnostic results
Sign | Characteristic of the sign | ||
|---|---|---|---|
Mild form of the disease | Moderate form of the disease | Severe form of the disease | |
Severity and duration of intoxication | Absent or mildly expressed weakness, nausea, decreased appetite, lasting 5–7 days. | Moderate intoxication (anorexia, weakness, sleep disturbances, nausea, vomiting, etc.) | Pronounced symptoms of intoxication (progressive general weakness, drowsiness, dizziness, anorexia, recurrent vomiting) |
Intensity and duration of skin jaundice | Mild or moderate, 2–3 weeks | Intense, 3–4 weeks, up to 40–45 days in cholestatic syndrome | Intense, may progress alongside increasing intoxication, exceeding 4 weeks |
Tachycardia | Absent | Absent, tendency to bradycardia | Appearing alongside the development and progression of jaundice |
Hemorrhagic syndrome | Absent | Absent or mild – isolated skin petechiae and epistaxis | Petechial skin rash, epistaxis, "coffee ground" emesis, injection site hemorrhages, "tarry" stools |
Liver size | Normal or enlarged up to 3 cm | Enlarged by 3–4 cm | Sharp decrease in size with disease progression, tenderness of the edge |
Bilirubin, µmol/L | up to 100 | from 100 to 200 | More than 200 |
Prothrombin index, % | More than 60 | 50-60 | Less than 50 |
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Hepatitis C is a liver disease caused by the hepatitis C virus.
The source of infection includes patients with active hepatitis C and latent carriers of the virus.
Transmission route: through infected blood, its components, and injection equipment. In drug users, via repeated syringe sharing. Infection is also possible through injection equipment used for body piercing and tattooing.
The incubation period, i.e., the time from infection to clinical manifestations, ranges from 2 to 26 weeks.
In most cases, primary infection causes no clinical manifestations, and a person may remain unaware of the disease for years while serving as a source of infection. People often discover they are carriers of the hepatitis C virus during routine blood tests in a regular medical check-up or when attempting to donate blood.
In cases of acute onset, the initial period lasts 2–3 weeks and is accompanied by joint pain, weakness, and digestive disorders; fever is rarely observed. Jaundice occurs in approximately 20% of patients with acute hepatitis C.
Psychological depression and chronic fatigue are noted more frequently than other symptoms. The greatest danger is posed by the chronic form, which frequently progresses to cirrhosis and liver cancer. A chronic course develops in 50–80% of individuals who have had acute hepatitis C.
Prevention consists of interrupting the transmission routes of the hepatitis C virus:
- avoid non-medical drug use;
- use disposable instruments for piercing, pedicure, manicure, and tattooing;
- practice safe sex (use condoms during sexual intercourse);
- strictly observe household hygiene rules.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
No.