Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two

Abstract

Background & Aims: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.

Depressive and Anxious Symptoms in Hepatitis C Virus Infected Patients Receiving DAA-Based Therapy

“…The periodical clinical assessment imposed by the Romanian National Program for HCV interferon-free therapy (Figure 1) has revealed the presence of DAAs side-effects during the treatment administration, but for our study's purposes, we have evaluated them at EOT, respectively SVR. At EOT, these adverse effects were recorded in almost a third of the whole study sample, and, similar to the literature [2,12,15] and clinical guidelines [4,18,19] there was pruritus (12.22%), fatigue (8.88%), headache (6.66%) and insomnia (6.66%). Twelve weeks later, at SVR, the medication's side effects were not present (Table 7).…”

“…The study sample consisted of 90 consecutive patients diagnosed with HCV infection: compensated hepatic cirrhosis (Child Pugh A or B) or hepatitis. During the study period, all the subjects were under treatment with DAAs: Ombitasvirum/Paritaprevirum/Ritonavirum/Dasabuvirum combination for 12 weeks, according to the Romanian National Protocol for HCV infected patients (2017) [ 17 ] and to the guidelines of the Romanian Society of Gastroenterology and Hepatology (RSGH) [ 18 , 19 ] respecting the recommendations of the European Association for the Study of the Liver [ 4 ]. These patients were recruited from those who received DAAs treatment in the Romanian national program of interferon-free therapy for HCV infection.…”

Perceived Stress in Hepatitis C Virus Infected Patients under the DAA-Based Therapy

“…The subjects of the study were outpatients under the treatment and monitoring process in the Gastroenterology Clinic of the Emergency Hospital in Craiova, Dolj County, Romania. All received pharmacological therapy with DAAs: Ombitasvirum/Paritaprevirum/Ritonavirum/Dasabuvirum combinations for a 12-week period, in accordance with the guidelines provided by the Romanian Society of Gastroenterology and Hepatology (RSGH) [18,19], the European Association for the Study of the Liver [20], and the Romanian National Protocol for HCV infected patients (no. 280, code J05AP) (2017) [21].…”

Modeling the Puzzle of Hepatitis C Epidemiology in Romania: A Pathway to Control

“…Traditionally, Romania is identified as one of the countries where high prevalence values of HCV were historically predicted [19,20]. Therefore, it was chosen to integrate the country pool of the Let's End HepC (LEHC) project's first phase, which was developed by the Unit of Public Healthcare of Healthcare Sciences Institute/Catholic University of Portugal (ICS/UCP).…”

“…Up until 1998, it was assumed that the diagnose of hepatitis C was still not conducted, therefore it is considered 0%. For the period 1999-2018, a cumulative diagnose rate of approximately 16% [20,[25][26][27] was considered, regardless of gender, age group and disease stage (as for blood products and prisoners' populations). Acknowledging that the remaining epidemiological indicators corresponded to the ones identified in an initial diagnosis phase, the year 1999 was assumed as the year in which data should be set.…”