Wednesday 7 September 2016

Patterns of Care Among Patients With Genotype 1 Hepatitis C Virus in Europe


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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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