Department of Medicine, University of South Alabama College of Medicine, Mobile, AL, USA. firstname.lastname@example.org.
Internal Medicine Department, USA Medical Center, 2451 USA Medical Center Blvd, Mobile, AL, 36617, USA. email@example.com.
Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, AL, USA.
To assess the true efficacy of direct acting antiviral (DAA) therapy in real-world clinical practice, taking into account those patients that do not complete therapy or the necessary follow-up to establish sustained viral response (SVR).
Retrospective data collection of 261 genotype 1 HCV-infected patients, treatment naïve or treatment experienced, treated with ledipasvir/sofosbuvir combination therapy at an academic medical center. All patients received individualized teaching and counseling prior to starting therapy stressing importance of compliance with laboratory monitoring and treatment completion. Intention to treat SVR rates (ITT-SVR) and per-protocol SVR rates (PP-SVR) were calculated. Chi-squared test was used to compare the number of subjects lost to follow-up in the treatment-naïve vs. treatment-experienced groups. Characteristics of noncompliant patients were compared to compliant patients.
ITT-SVR rates for the entire cohort were 74%, significantly lower than the 95% PP-SVR rate for the compliant patients (p < 0.001). ITT-SVR was lower in treatment-naïve patients compared to treatment-experienced patients (68% vs. 86%). Among the entire cohort, 22% of patients either discontinued therapy prematurely (7%) or did not return for SVR assessment (15%). Failure to complete therapy or return for SVR assessment was statistically more common among treatment-naïve patients compared to treatment-experienced patients (28% vs. 11%, p = 0.0016).
There is a significant rate of noncompliance among patients treated with DAA in real-world clinical practice despite pre-treatment education efforts. The ITT-SVR rates observed in clinical practice were significantly lower than those reported by clinical trials, and this difference was most pronounced among treatment-naïve patients.