Sofosbuvir-Containing Regimens for Chronic Hepatitis C Are Successful in the Safety-Net Population: A Real-World Experience

Abstract

Background Vulnerable populations are disproportionately affected by hepatitis C virus infection (HCV), and experience high rates of health disparity. There is no data on real world experience with highly efficacious direct acting anti-HCV (DAA) treatment in this population. Aims We aimed to evaluate the real world experience with sofosbuvir-based regimens among a vulnerable HCV-infected population. Methods HCV treatment response was assessed among 204 patients who completed 12–24 weeks of sofosbuvir (SOF)-based regimens (in combination with pegylated interferon and ribavirin, simeprevir, ledipasvir, or daclatasvir) at the San Francisco safety-net healthcare system liver specialty clinic between January 2014 and December 2015. Virologic response during therapy was assessed at weeks 4, 8, end of therapy, and 12 weeks treatment discontinuation (SVR 12). Results Patient characteristics were median age 58 years, 60% male, 42% Caucasian (21% black, 19% Hispanic), 72% had genotype 1 (23% genotype 2 or 3), and the median baseline log10 HCV viral load was 6.1 IU/ml and alanine transaminase 63 U/L. Cirrhosis was present in 36% (of whom 40% were decompensated) and 18% were HCV treatment experienced. Overall, SVR 12 was achieved in 97% (99% genotype 1, 100% genotype 2, 84% genotype 3). Five of six (83%) of patients who relapsed had decompensated cirrhosis and 67% were also non-adherent to therapy. On treatment virologic response did not impact SVR. Conclusions High rates of sustained virologic response can be achieved in safety-net HCV-infected patients. Access to DAA-based regimens is critical to addressing HCV-related health disparity in this at risk population.

Underserved Does Not Mean Undeserved: Unfurling the HCV Care in the Safety Net

“…Stewart, et al evaluated an urban public hospital cohort of 435 HCV patients to assess real-world SVR rates in an underserved safety-net setting 3 . In this study, the investigators utilized multiple imputation statistical methods to account for the 28% missing SVR values and reported an overall SVR rate of 89%, which is comparable to that reported in other safety-net settings 6,7 . While using multiple imputation technique enhances validity of findings, the assumption that the missing data are from random subjects may be erroneous 8 .…”

“…Though real-world studies to date continue to report high SVR rates 4,5 , even for underserved populations (e.g. patients lacking access to healthcare due to lack of insurance, low socioeconomic status, homelessness, substance abuse, mental illness, or other factors) 6 , Marshall, et al raised concern that true SVR rates may be much lower when factoring in inconsistencies in treatment completion or post­treatment testing needed to calculate the SVR 1 . In their study of 261 HCV genotype 1 patients, 22% were lost to follow-up (7% did not complete therapy and 15% did not return for SVR testing after completion of therapy).…”

Race and Hepatitis C Care Continuum in an Underserved Birth Cohort

“…In our study, nearly 100% of birth cohort patients engaged in care were screened with antibody testing for HCV, a screening rate significantly higher than the 21-64% reported in other populations also engaged in care. [24][25][26] Differences in practice setting and their established screening protocols (e.g., jail, primary care clinics, integrated care systems), as well as the higher rates of HCV risk factors observed in the underserved that may translate into heightened awareness of HCV among patients and providers, [27][28][29] may have contributed to the wide range of reported screening rates. Interestingly, with the introduction of the birth cohort recommendations, we observed the greatest rise in HCV screening and treatment among APIs, which may be attributed to lower rates of traditional HCV risk factors observed in this population.…”

Liver Disease Monitoring Practices After Hepatitis C Cure in the Underserved Population

“…In the United States, underserved patient populations are disproportionately affected by HCV and face high rates of coexisting mental health and substance use . Recommended disease monitoring, such as laboratory testing, clinic visits, and imaging studies for HCC screening, may be particularly challenging in this population despite high SVR rates of 97% using DAA therapies, similar to reports from other HCV populations . To date, there are limited data on current post‐SVR monitoring and HCC screening practices in the DAA era, and no data are available from potentially difficult to engage and underserved populations.…”

“…(16,17) Recommended disease monitoring, such as laboratory testing, clinic visits, and imaging studies for HCC screening, may be particularly challenging in this population despite high SVR rates of 97% using DAA therapies, similar to reports from other HCV populations. (18) To date, there are limited data on current post-SVR monitoring and HCC screening practices in the DAA era, (19) and no data are available from potentially difficult to engage and underserved populations. Thus, in this study, we aimed to address this gap by characterizing and evaluating current liver disease monitoring practices in a cohort of underserved patients infected with HCV who achieved SVR after DAA therapy.…”