Methods
Search Strategy
Relevant studies and abstracts were obtained by searching MEDLINE (1948 to July 2011) and EMBASE (1980 to July 2011). There was no language restriction and the initial search strategy was developed from the search headings 'liver disease' and 'clinical trial' removing references to 'hepatitis B', 'hepatitis A', 'autoimmune' or 'alcohol'. A further search was done for the term 'antiviral' or 'antivirus agent' or 'antiviral activity' and 'clinical trial'. These searches were limited from January 2008 to July 2011. Abstracts and poster presentations from the annual European Association Study of the Liver, AASLD, Digestive Disease Week and Asian Pacific Association for the study of the Liver were searched for relevant material for the same time period. In addition, the reference lists from the retrieved papers were hand searched.
Selection Criteria (Figure 2)
(Enlarge Image)
Figure 2.
Systematic review search
Studies were included if they included an adult population (age > 18 years); had a serological diagnosis of HCV; had an intervention and had an outcome measure. This could either be an SVR, Early Virological Response (Undetectable HCV RNA at week 12), Rapid Virological response (undetectable HCV RNA at week 4) or rate of fall of HCV RNA levels. Studies were excluded if patients were co-infected with other viruses such as HIV or HBV.
Data Extraction
A spreadsheet was created that recorded study characteristics including authors, study title, sample size, publication year, type of intervention, name of drug, whether the drug was used with PEG/RIB or as monotherapy. Patient characteristics were recorded such as genotype, if the patient was treatment naïve or experienced and ethnicity (if relevant). The study results were measured by looking at percentage of patients with rapid virological response (RVR- undetectable HCV RNA at week 4), early virological response (EVR- undetectable HCV RNA at week 12) or sustained virological response (SVR- undetectable HCV RNA 12 weeks after treatment), rate of fall of HCV RNA levels, notable side effects and conclusions.