Treatment Discontinuation, Adherence, and Real-World Effectiveness Among Patients Treated with Ledipasvir/Sofosbuvir in the United States

Abstract

IntroductionLedipasvir/sofosbuvir (LDV/SOF) for hepatitis C virus (HCV) treatment provides an oral interferon-free treatment regimen with high rates of sustained virologic response (SVR). This study assessed treatment discontinuation, factors associated with treatment completion, and real-world effectiveness.MethodsPatients with HCV treated with LDV/SOF between October 2014 and June 2015 and enrolled in a large US health plan were identified. Expected treatment duration was calculated based on IDSA/AASLD treatment guidelines and US labels using data for genotype, initial treatment regimen, baseline cirrhosis, and prior treatments. Logistic regression was used to identify factors associated with treatment completion, controlling for patient characteristics.ResultsThe study included 1483 LDV/SOF patients. Mean age was 59.7 years, most were male (63.9%), had commercial insurance (51.9%), and were treatment-naïve (85.6%). Cirrhosis or end stage liver disease was present in 46.1%. Among patients with an expected 8-week treatment regimen, 49.4% were treated for longer. Most patients (99.8%) with expected 12-week treatment durations were adherent to the expected treatment duration. Treatment-experienced patients [odds ratio (OR) 0.124, p < 0.001] and those on Medicare (OR 0.382, p = 0.039) had lower odds of completing the expected treatment regimen, while males were more likely to complete treatment than females (OR 3.235, p = 0.003). SVR12 in patients treated with LDV/SOF was 89.4% (n = 76/85).ConclusionHalf of patients eligible for an 8-week treatment regimen with LDV/SOF were treated longer, while most patients with a 12-week regimen were adherent to the expected treatment duration. Prior HCV treatment, female gender, and Medicare Advantage insurance were associated with lower odds of treatment completion. Overall SVR12 was 89.4%.FundingMerck & Co. Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s40121-017-0163-0) contains supplementary material, which is available to authorized users.

Impact of a digital medicine programme on hepatitis C treatment adherence and efficacy in adults at high risk for non‐adherence

“…Previous studies have demonstrated relatively high rates of SVR with DAAs in patients with recent or ongoing drug use in clinical trials and observational studies 35,36 . However, adherence to DAAs is variable 37 and may require intensive support strategies, especially in populations with transient living conditions 38,39 . For example DOT and close follow‐up visits have been recommended for persons not adequately engaged in care to help drive the likelihood of HCV cures after starting DAAs 40,41 .…”

Obstacles to successful treatment of hepatitis C in uninsured patients from a minority population

“…The introduction of direct acting antiviral medications (DAAs) [ 2 ] for the treatment of HCV with fewer side effects [ 10 ], and the recommendation that all chronically infected HCV patients be treated [ 8 ], has had a significant impact [ 11 ]. These medications have sustained virologic response (SVR) rates as high as 97% in clinical trials, compared to approximately 50% with interferon-based regimens [ 12 ]. SVR is associated with decreased morbidity and mortality, and improved quality of life [ 13 ].…”

Hepatitis C Virus Epidemiology and the Impact of Interferon-Free Hepatitis C Virus Therapy

“…They remain highly effective among special populations, such as patients with chronic kidney disease (Ridruejo et al 2018), hemoglobinopathies (Origa et al 2017), HIV/HCV-coinfected individuals (Bhattacharya et al 2017; Hézode 2018), PWID (Grebely et al 2017(Grebely et al , 2018a, older individuals (Conti et al 2017), and those with advanced liver disease (Holzmann et al 2018). In real-life conditions, also, DAAs are highly effective (Cornberg et al 2017;Puenpatom et al 2017;Ji et al 2018). Overall, DAAs are significantly more effective, better tolerated, and easier to take than previous treatments.…”