Long-term effects of treatment and response in patients with chronic hepatitis C on quality of life. An international, multicenter, randomized, controlled study

Abstract

Background: Hepatitis C decreases health related quality of life (HRQL) which is further diminished by antiviral therapy. HRQL improves after successful treatment. This trial explores the course of and factors associated with HRQL in patients given individualized or standard treatment based on early treatment response (Ditto-study).

Methods: The Short Form (SF)-36 Health Survey was administered at baseline (n = 192) and 24 weeks after the end of therapy (n = 128).

Results: At baseline HRQL was influenced by age, participating center, severity of liver disease and income. Exploring the course of HRQL (scores at follow up minus baseline), only the dimension general health increased. In this dimension patients with a relapse or sustained response differed from non-responders. Men and women differed in the dimension bodily pain. Treatment schedule did not influence the course of HRQL.

Conclusions: Main determinants of HRQL were severity of liver disease, age, gender, participating center and response to treatment. Our results do not exclude a more profound negative impact of individualized treatment compared to standard, possibly caused by higher doses and extended treatment duration in the individualized group. Antiviral therapy might have a more intense and more prolonged negative impact on females.

Figure 1

Treatment allocation of patients with chronic hepatitis C according to initial virologic response pattern in the Ditto study. Abbreviations: Ribavirin (RBV), Rapid viral response (RVR), Slow partial response (SPR), Flat partial response (FPR), null response (NUR), Standard combination therapy (STD).

Figure 2

Mean scores of the different SF36 dimensions at t = 0 from the participating centers. Barcelona; Spain, Paris; France, Geneva; Switzerland, Gothenburg; Sweden, Parma; Italy, Rotterdam; The Netherlands, Rehovot; Israel.

Figure 3

Mean scores with 95% confidence intervals of the different dimensions of the SF-36 in men at baseline and at 24 weeks after completion of treatment (follow up).

Figure 4

Mean scores with 95% confidence intervals of the different dimensions of the SF-36 in females at baseline and at 24 weeks after completion of treatment (follow up).