Ribavirin Use in Conjunction with DAA Therapy Predicts Mental Health Decline in Patients with HCV

Joop E. Arends, MD

Concomitant ribavirin use is an independent predictor of mental health-related quality-of-life in patients with hepatitis C virus (HCV) infection and an inherited bleeding disorder who are on a direct-acting antiviral (DAA) regimen, according to a prospective cohort study led by Joop E. Arends, MD, of the University Medical Center Utrecht Affiliated to Utrecht University. Scores on the mental component of the Short Form-36 (SF-36) also appear to decrease transiently during concomitant therapy.

“In a time of increasing health care costs, it is important to evaluate patient outcomes especially with expensive DAAs,” Arends told MD Magazine^®. “Real-world data with PROs [patient-reported outcomes] have not yet been published and that is one of the important contributions of our study. In addition, it still shows the effects of ribavirin [RBV] on patient outcomes, and although in Western world settings we now switch to second generation DAAs in which RBV is not needed anymore, there is still a place for RBV.”

Patients with HCV infection who received an oral DAA therapeutic regimen at a single center in The Netherlands during 2015—2016 were recruited for analysis (n = 68). Approximately 85% of patients were receiving sofosbuvir-based DAA regimens compared with 15% of patients who received a DAA regimen comprised of ombitasvir/paritaprevir/ritonavir/dasabuvir.

The investigators assessed various PROs, including patient-reported medication adherence, health-related quality-of-life on the SF-36, performance status using the 100-point Karnofsky Performance Status scale, physical activity level, paid labor productivity, nutritional state as assessed by body mass index (BMI) and Jamar hand grip strength (HGS), as well as beliefs about medicine at baseline, end of treatment (EOT), and 12-week follow-up. Using a multiple regression analysis, the investigators examined whether potential factors existed in these patients that predicted these PROs.

The majority of patients experienced a sustained virologic response (97%), and most patients also reported high medication adherence (97%). Health-related quality of life Physical Component Summary scores did not significantly change from baseline to EOT and follow-up (43.2 ± 11.9 vs 44.9 ± 10.3 vs 44.7 ± 10.9, respectively; P = .71).

The mental component of the SF-36, however, significantly decreased in a transient manner during therapy (49.2 ± 11.9 [baseline] vs 44.6 ± 10.3 [EOT] vs 49.9 ± 12.6 [12-week follow-up]; P<.01).

Only 1 independent predictor was found for decreased SF-36 mental component score: concomitant RBV-use. In the overall cohort, no changes were found from baseline to EOT in BMI (25.7 ± 4.5 vs 25.6 ± 4.4, respectively; P = .8) and Jamar HGS (39.7 ± 13.0 vs 37.4 ± 11.9, respectively; P = .56).

Limitations of the study include its relatively small sample size as well as the short duration of follow-up (12 weeks). Additionally, only patients receiving care in The Netherlands were included, likely limiting the generalizability of the findings across the entire HCV patient population.

“The drawback of our study is the limited sample size, [and] so a larger population would be ideal,” Arends added when asked to comment on the study’s limitations. “The question is whether that will be done given that is quite laborious to collect all these questionnaires on the right time points in daily clinical practice.”

The study, “The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study,” was published in Infectious Diseases and Therapy.