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Discussion

The results of six RCTs were included in this systematic review, all in patients who were eligible for shortened treatment duration. Treatment in patients with genotype 1 was evaluated in four trials,–, genotype 2 in one trial and genotypes 2 and 3 in one trial. All studies compared standard treatment duration (48 weeks for genotype 1, 24 weeks for genotypes 2 and 3) to a shorter duration (24 or 16 weeks, respectively). In five of the RCTs the patients had LVL at baseline (based on mean viral load), while in one RCT less than one-quarter of patients had LVL (defined as HCV RNA < 400,000 IU/ml) at baseline. However, it was included in our systematic review because SVRs were presented for the subgroup of those with LVL who attained an RVR (i.e. the patient subgroup meeting the licensed criteria for receiving shortened courses of therapy, and thus within the scope of the NICE appraisal). Note, however, that this subgroup constituted only 10% of the total study population. In only one trial did all randomised patients consist of those with LVL and who achieved an RVR. In addition, none of the studies was powered for this subgroup and results should therefore be interpreted with caution.

Background

Hepatitis C is a slowly progressing infectious disease of the liver arising from the blood-borne hepatitis C virus (HCV). First identified in 1989, HCV belongs to the Flaviviridae family of viruses. It is a ribonucleic acid (RNA) virus, of which there are six genetic variations, known as genotypes (e.g. 1, 2, 3, etc.), the prevalence of which varies considerably between countries., In England and Wales, the most prevalent genotypes are 1 and 3, representing more than 90% of all diagnosed infections. Genotype 3a remains the most common, with a prevalence of 39%, followed by genotype 1a (22%). Response to treatment is strongly influenced by HCV genotype (see Current service provision and Description of technology under assessment).

Clinical effectiveness

Literature searches identified 1317 references, after the removal of duplicates. A further 1389 references identified from searches conducted for our previous hepatitis C technology assessment reports, were screened according to the inclusion criteria for the present review. After further de-duplication, the total number of records screened was 2400. Following initial screening of titles and abstracts, 2310 references were excluded because they did not meet the inclusion criteria and full copies of 90 articles were retrieved. Of these, 82 were excluded on further inspection, leaving eight included studies. The total number of published papers included at each stage of the systematic review is shown in the flow chart in Figure 1; the list of excluded studies can be seen in Appendix 7.

Economic analysis

A systematic review was undertaken to identify economic evaluations of peginterferon alfa and ribavirin in patients with chronic HCV in the subgroups outlined above (see Chapter 3 for methods). The details of the search strategy are documented in Appendix 2.

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