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To assess clinical characteristics and patterns of care among patients with Genotype 1 (G1) Hepatitis C virus (HCV) in EU,
a multi-center retrospective chart-review study of HCV patients was conducted in the EU (France/Germany/Italy/Spain/
UK) in 2014 to collect de-identified data on diagnosis, clinical status, and treatment patterns. Physicians were screened
for duration of practice (≥3yrs) and patient volume (≥15 HCV patients/month) and recruited from a large panel to be geographically
representative. Medical charts of the next 10 consecutive HCV patients were abstracted. 2067 eligible G1 HCV
patients were included in the final analysis (France: 374/Germany: 506/Italy: 412/Spain: 475/UK: 300). Patient characteristics
included (France/Germany/Italy/Spain/UK) G1-subtype A (49%/38%/30%/31%/58%) or B (44%/47%/67%/61%/28%);
current fibrosis scores: F0: 9%/15%/5%/7%/18%, F1: 18%/24%/24%/24%/29%, F2: 24%/23%/31%/23%/17%, F3:
20%/14%/17%/19%/10%, F4: 28%/5%/20%/22%/17%; latest mean alanine aminotransferase levels:58/90/95/62/73 IU/
mL; patients with viral load >1Million IU/mL: 23%/12%/33%/27%/14%. Treatment patterns included (France/Germany/Italy/Spain/UK)-
currently treated:23%/28%/20%/17%/20%, treatment naïve/never been treated:38%/40%/41%/41%/52%,
not currently treated (previous treatment non-responder, discontinued or relapsed, or therapy complete and awaiting
sustained viral response): 21%/20%/29%/30%/22%, not currently treated for other reasons: 19%/12%/11%/13%/6%. Disease
burden was high in this cohort of G1 HCV patients and only a small proportion of patients were not treated owing
to achieving sustained viral response.
Hepatitis C, caused by hepatitis C virus (HCV) is often asymptomatic
and is characterized by slow disease progression. An
estimated 160 million individuals may be infected with HCV
globally and the corresponding estimate for Europe is approximately
5.5 million. Globally, genotype 1 (G1) is estimated
to account for 46.2% of all HCV cases. G1 is the most predominant
genotype in Europe (estimated to be between 59% and
89% depending on the region); subtype 1a is most commonly
associated with intravenous drug abuse and subtype 1b is
typically observed in patients who have acquired HCV through
a blood transfusion. In Europe, approximately 67% of HCV
cases are acquired through IV drug use, and approximately 5%
through blood and blood products.
Persistent HCV infection is associated with the development
of liver cirrhosis, hepatocellular cancer, liver failure, and
death, while HCV is a common cause of death in HIV-positive
patients. As incidence of HCV infection decreases in the
developed world, deaths from liver disease secondary to HCV
infection are expected to increase over the next 20 years.
Vaccination against hepatitis C is not yet available; however,
current treatment options include antivirals and agents
that stop the virus from replicating and may eliminate the infection
altogether. There is evidence indicating that
some patients do not receive treatments to manage their HCV
infection. Research highlighting the current patterns of care
in the key countries in Europe could help portray the current
status of HCV management in that region, especially among
the most prevalent HCV patients (i.e., G1 type)The study was a multi-country, multi-center retrospective
medical chart review of adult (>18 years) HCV patients conducted
in the big-5 European countries, namely, France, Germany,
Italy, Spain & United Kingdom (UK)) in Oct-Dec 2014.
Physicians were randomly sampled in each of the countries
using online physician panels using geo-dispersion samplingmethods (whereby, stakeholders are recruited from a wide
selection of clinics/hospitals in a given geography representing
the modality of care delivery in HCV arena, with each institution
contributing almost equal number of study-eligible
patient charts); this sampling methodology ensures physician
recruitment from diverse locations (urban, sub-urban and
rural centers) and practice settings (hospitals and individual
(community/private) clinics), and avoids physician sampling
biases occasionally associated with selection/use of only limited
set of sites, especially in research related to widely prevalent
disease(s), thereby enabling the generalization of study
findings in a given geography.
Invitations to participate in research were sent to a random
set of physicians (hepatologists, gastroenterologists, hepatogastroenterologists,
internal medicine and infectious disease
specialists) in the existing online physician panels. The physicians
representing both hospital-based and private practices
in each geography, personally responsible for managing at
least 15 HCV patients per month and having >3 years of clinical
practice experience were screened for study participation.
Each physician reported de-identified anonymous data on 10
next consecutive patients they encountered in their practice
within the study recruitment window. HCP patient charts
were eligible for the study if the patient was being managed
as part of usual care, without any participation in clinical trials.
An electronic data collection form was used to collect the following
data elements from eligible HCV patient charts: patient
demographics, clinical characteristics (incl. classification
of liver histology per International Association for Study of
the Liver (IASL)), comorbidities, laboratory values (e.g., Viral
Load and alanine aminotransferase (ALT)) and HCV treatment
patterns/dynamics. Only de-identified anonymous data was
collected from the patient charts by the treating physicians.
This mode of data collection method met the criteria for local
ethics review exemption per the respective physician/site
requirements in the respective countries. Study data analysis
focused on G1 HCV patients. Descriptive statistics were utilized
to analyze the data.Data corresponding to 2067 eligible medical charts of HCV patients
with G1 genotype were included in the study analysis;
18% were from France, 24% from Germany, 20% from Italy,
23% from Spain and 15% from the UK. The mean age of patients
was 51yrs. The cohort was predominantly male and
caucasian; intravenous drug was the main route of infection
reported across the studied countries, ranging from 17% (Germany)
to 55% (UK). (Table 1).
Key comorbidities in the study cohort encompassed cardiovascular
disease (12% (range: 3% (UK) – 20% (Germany))), Steatosis
(12% (range: 5% (UK) – 17% (Italy))), HIV (11% (range:
4% (Germany) – 18% (France))), depression (11% (range: 5%
(Italy) – 16% (UK))) and diabetes (11% (range: 8% (UK/Italy) –
13% (Germany))).
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