Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3.

Background & Aim: Understanding the real-world effectiveness of all-oral hepatitis C virus (HCV) regimens informs treatment decisions. We evaluated the effectiveness of daclatasvir + sofosbuvir ± ribavirin (DCV + SOF ± RBV) and velpatasvir/sofosbuvir (VEL/SOF) ± RBV in patients with genotype 2 and genotype 3 infection treated in routine practice.

Methods: This observational analysis was carried out in an intent-to-treat cohort of patients with HCV genotype 2 and genotype 3.

Direct-acting antiviral sustained virologic response: Impact on mortality in patients without advanced liver disease.

Unlabelled: The impact of sustained virologic response (SVR) on mortality after direct-acting antiviral (DAA) treatment is not well documented in patients without advanced liver disease and affects access to treatment. This study evaluated the impact of SVR achieved with interferon-free DAA treatment on all-cause mortality in hepatitis C virus-infected patients without advanced liver disease. This observational cohort analysis was comprised of 103,346 genotype 1, 2, and 3, hepatitis C virus-monoinfected patients without advanced liver disease, defined by FIB-4 ≤3.

Impact of Sustained Virologic Response with Direct-Acting Antiviral Treatment on Mortality in Patients with Advanced Liver Disease.

The impact of sustained virologic response (SVR) on mortality after direct-acting antiviral treatment is not well documented. This study evaluated the impact of direct-acting antiviral-induced SVR on all-cause mortality and on incident hepatocellular carcinoma (HCC) in 15,059 hepatitis C virus-infected patients with advanced liver disease defined by a FIB-4 >3.25.

Evaluation of hepatitis B reactivation among 62,920 veterans treated with oral hepatitis C antivirals.

Unlabelled: Reactivation of hepatitis B virus (HBV) has been reported in hepatitis C virus-infected individuals receiving direct-acting antiviral (DAA) therapy. The overall risk among patients with current or prior HBV infection in the context of DAA treatment is unknown. The aim of this evaluation was to identify and characterize HBV reactivation among veterans treated with oral DAA therapy.

Effectiveness of All-Oral Antiviral Regimens in 996 Human Immunodeficiency Virus/Hepatitis C Virus Genotype 1-Coinfected Patients Treated in Routine Practice.

Background.: Large cohorts are needed to assess human immunodeficiency virus (HIV)/hepatitis C virus (HCV) real-world treatment outcomes. We examined the effectiveness of ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF ± RBV) and ombitasvir/ paritaprevir/ritonavir plus dasabuvir (OPrD) ± RBV in HIV/HCV genotype 1 (GT1)-coinfected patients initiating HCV therapy in clinical practice.

Real-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patients.

Background: Predictors of sustained virological response (SVR) to all-oral HCV regimens can inform nuanced treatment decisions. We evaluated effectiveness and identified predictors of SVR for ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ±RBV) and ombitasvir/paritaprevir/ritonavir + dasabuvir (OPrD) ±RBV in patients treated in routine practice.

Methods: Observational, intent-to-treat cohort of 21,142 genotype-1 patients initiating 8 or 12 weeks of LDV/SOF ±RBV or 12 weeks of OPrD ±RBV at any Veterans Affairs facility.

Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patients.

Unlabelled: Real-world effectiveness data are needed to inform hepatitis C virus (HCV) treatment decisions. The uptake of ledipasvir/sofosbuvir (LDV/SOF) regimens across health care settings has been rapid, but variations often occur in clinical practice. The aim of this study was to assess sustained virologic response (SVR) of LDV/SOF±ribavirin (RBV) in routine medical practice.

Impact of race/ethnicity and gender on HCV screening and prevalence among U.S. veterans in Department of Veterans Affairs Care.

Objectives: We assessed HCV screening and prevalence among veterans and estimated the potential impact of complete birth cohort screening, accounting for the disparate HCV disease burden by race/ethnicity and gender.

Methods: We used the Department of Veterans Affairs (VA) Corporate Data Warehouse to identify birth dates, gender, race/ethnicity, and laboratory tests for veterans with at least 1 VA outpatient visit in 2012. We calculated HCV screening rates, prevalence, and HCV infection incident diagnosis.

A population approach to disease management: hepatitis C direct-acting antiviral use in a large health care system.

Background: The introduction of the first direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV), telaprevir and boceprevir, marked a unique event in which 2 disease-changing therapies received FDA approval at the same time. Comparative safety and effectiveness data in real-world populations upon which to make formulary decisions did not exist.

Objective: To describe the implementation, measurement, and outcomes of an enduring population-based approach of surveillance of medication management for HCV.

Impact of provider type on hepatitis C outcomes with boceprevir-based and telaprevir-based regimens.

Goals: To examine the effect of provider type on outcomes and safety in a large hepatitis C virus (HCV)-infected cohort treated in routine medical practice.

Background: Nonphysician providers (NPP) are uniquely positioned to expand health care infrastructure to meet HCV treatment demands.

Study: Retrospective, observational cohort analysis of 820 HCV genotype 1-infected veterans initiated on peginterferon/ribavirin and boceprevir or telaprevir in routine medical practice at 94 VA facilities before January 1, 2012 and followed through July 30, 2013.

Early virologic responses and hematologic safety of direct-acting antiviral therapies in veterans with chronic hepatitis C.

Background & Aims: There are limited data on the early effectiveness of direct-acting antiviral (DAA) therapies for patients with hepatitis C virus (HCV) infection in routine medical practice. We aimed to evaluate real-world experience with DAA-based regimens.

Methods: By using the Veterans Affairs' Clinical Case Registry, we conducted a prospective observational intent-to-treat analysis of veterans infected with HCV genotype 1 who began treatment with pegylated interferon, ribavirin, and boceprevir (BOC, n = 661) or telaprevir (TVR, n = 198) before January 2012.

A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C.

Background & Aims: The effectiveness of hepatitis C virus (HCV) treatment with pegylated interferon and ribavirin usually is evaluated by the surrogate end point of sustained virologic response (SVR), although the ultimate goal of antiviral treatment is to reduce mortality. The impact of SVR on all-cause mortality is not well documented by HCV genotype or in populations in routine medical practice with substantial comorbidities.

Methods: From the US Department of Veterans Affairs (VA), we identified all patients infected with HCV genotypes 1, 2, or 3, without human immunodeficiency virus co-infection or hepatocellular carcinoma before HCV treatment with pegylated interferon and ribavirin, who started HCV treatment from January 2001 to June 2007, stopped treatment by June 2008, and had a posttreatment HCV RNA test result of SVR or no SVR.

National quality forum performance measures for HIV/AIDS care: the Department of Veterans Affairs' experience.

Background: Information technology promises to improve health care through reporting of standardized quality-of-care measures. In 2008, the National Quality Forum (NQF) first endorsed performance measures for human immunodeficiency virus (HIV)/AIDS care. Little is known about performance on these measures in routine medical practice.

Clinical Case Registries: simultaneous local and national disease registries for population quality management.

The Department of Veterans Affairs (VA) has a system-wide, patient-centric electronic medical record system (EMR) within which the authors developed the Clinical Case Registries (CCR) to support population-centric delivery and evaluation of VA medical care. To date, the authors have applied the CCR to populations with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Local components use diagnosis codes and laboratory test results to identify patients who may have HIV or HCV and support queries on local care delivery with customizable reports.

Postmarketing use of enfuvirtide in veterans: provider compliance with criteria for use, overall efficacy, and tolerability.

Background: Most enfuvirtide outcomes data come from controlled trials of limited duration rather than from routine experience. Because of its uniqueness, the Veterans Health Administration (VHA) implemented specific enfuvirtide prescribing and follow-up criteria (criteria for use; CFU) and then assessed providers' compliance with these criteria and outcomes.

Objective: To report routine medical care experience with the prescribing, efficacy, and tolerability of enfuvirtide in a nonselective group of treatment-experienced, older, HIV-infected veterans.

Predictors of response of US veterans to treatment for the hepatitis C virus.

Unlabelled: The currently recommended treatment for hepatitis C virus (HCV) infection is pegylated interferon alfa (PEG-INF) and ribavirin, which can be difficult to tolerate. More information about predicting sustained virologic response (SVR) may allow more informed treatment decisions to be made. This retrospective observational cohort study identified predictors of SVR to PEG-INF and ribavirin in routine medical practice at 121 Department of Veterans Affairs facilities.

Retention in care: a challenge to survival with HIV infection.

Background: Patients with human immunodeficiency virus (HIV) infection need lifelong medical care, but many do not remain in care. The effect of poor retention in care on survival is not known, and we sought to quantify that relationship.

Methods: We conducted a retrospective cohort study involving persons newly identified as having HIV infection during 1997-1998 at any United States Department of Veterans Affairs hospital or clinic who started antiretroviral therapy after 1 January 1997.

Development and verification of a "virtual" cohort using the National VA Health Information System.

Background: The VA's integrated electronic medical record makes it possible to create a "virtual" cohort of veterans with and without HIV infection to monitor trends in utilization, toxicity, and outcomes.

Objectives: We sought to develop a virtual cohort of HIV-infected veterans by adapting an existing algorithm, verifying this algorithm against independent clinical data, and finally identifying demographically-similar HIV-uninfected comparators.

Research Design: Subjects were identified from VA administrative data in fiscal years 1998-2003 using a modified existing algorithm, then linked with Immunology Case Registry (ICR, the VA's HIV registry) and Pharmacy Benefits Management (centralized database of outpatient prescriptions) to verify accuracy of identification.

Effects of hepatitis C virus coinfection on survival in veterans with HIV treated with highly active antiretroviral therapy.

Background: With highly active antiretroviral therapy (HAART) available for patients with HIV, hepatitis C virus (HCV) infection has emerged as a potentially important cause of mortality in coinfected patients. Several studies have investigated the effect of coinfection on mortality, with conflicting results.

Methods: The study cohort consisted of HIV-infected veterans on HAART receiving care at US Department of Veterans Affairs facilities.