Hepatitis C - The impact of liver disease and new treatment regimens


In the past decade, inclusion of PROs in the clinical trials of CH-C patients has become increasingly important. The current data support the fact that CH-C patients suffer substantial PRO burden. This burden becomes significantly exaggerated during treatment with IFN + RBV with or without first generation DAAs. The impact of this impairment is not only on patients’ experience but also on work productivity and adherence to treatment regimen, indirectly affecting SVR rates. Early PRO assessment of IFN based therapy informed the medical community of the harshness of this treatment from the patients’ perspective partially explaining the low completion rate and consequently a very low ‘cure’ rate. With the development of the direct acting anti-viral agents, not only was there a substantial improvement in SVR rates, but also the tolerance for the second generation of DAA’s was substantially better. This improvement in patient experience was documented through substantially better PRO scores as compared to IFN regimens. Nevertheless, these regimens still contained RBV with its side effects and mild impairment of PROs. The newer IFN-free and RBV-free regimens are not only more advantageous in regard to the high efficacy and shorter duration of treatment, but also improvement of PROs during treatment and after achieving SVR. Although substantial data exist for LDV/SOF regimen, there are emerging data from 3D and simprevir regimens which support the same PRO concepts. In summary, the measurement of PRO’s established with the current clinical trials of the second generation of DAA’s have created a very robust and important programme addition to the field of liver disease. Of special importance is that across all SOF based clinical trials four PRO instruments (SF-36, CLDQ-HCV, FACIT-F and WPAI) were used. In fact, the consistent use of the same tools allowed the comparisons of PRO results which showed consistent results across these instruments providing support for the validity of these data. It is only with the inclusion of PROs that we can fully assess the impact of these new treatments on patients, their families and society. Nevertheless, further work is needed to document the benefit of PROs on treatment adherence. Direct and indirect economic benefit of PRO improvement must also be fully documented. Work must continue on providing practitioner led support and improvement in self-efficacy to patients to increase treatment adherence among HCV patients.



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