Hepatitis C Virus Clearance Cascade - United States, 2013-2022.

Approximately 2.4 million adults were estimated to have hepatitis C virus (HCV) infection in the United States during 2013-2016 (1). Untreated, hepatitis C can lead to advanced liver disease, liver cancer, and death (2). The Viral Hepatitis National Strategic Plan for the United States calls for ≥80% of persons with hepatitis C to achieve viral clearance by 2030 (3). Characterizing the steps that follow a person's progression from testing to viral clearance and subsequent infection (clearance cascade) is critical for monitoring progress toward national elimination goals. Following CDC guidance (4), a simplified national laboratory results-based HCV five-step clearance cascade was developed using longitudinal data from a large national commercial laboratory throughout the decade since highly effective hepatitis C treatments became available. During January 1, 2013-December 31, 2021, a total of 1,719,493 persons were identified as ever having been infected with HCV. During January 1, 2013-December 31, 2022, 88% of those ever infected were classified as having received viral testing; among those who received viral testing, 69% were classified as having initial infection; among those with initial infection, 34% were classified as cured or cleared (treatment-induced or spontaneous); and among those persons, 7% were categorized as having persistent infection or reinfection. Among the 1.0 million persons with evidence of initial infection, approximately one third had evidence of viral clearance (cured or cleared). This simplified national HCV clearance cascade identifies substantial gaps in cure nearly a decade since highly effective direct-acting antiviral (DAA) agents became available and will facilitate the process of monitoring progress toward national elimination goals. It is essential that increased access to diagnosis, treatment, and prevention services for persons with hepatitis C be addressed to prevent progression of disease and ongoing transmission and achieve national hepatitis C elimination goals.

Defining the hepatitis C cure cascade in an Urban health system using the electronic health record.

Hepatitis C virus (HCV) infection is a public health threat. The electronic health record (EHR) can be used to monitor patients along the HCV cure cascade and highlight opportunities for interventions to improve cascade outcomes. We developed an HCV patient registry using data from Grady Health System's (GHS) EHR and performed a cross-sectional analysis of 72 745 GHS patients who received anti-HCV testing from 2004 to 2016. We created a testing cascade: (1) anti-HCV reactive, (2) HCV RNA tested and (3) HCV RNA detectable; and a cure cascade: (1) HCV RNA detectable, (2) engaged in care, (3) treatment prescribed, (4) sustained virologic response (SVR) tested and (5) SVR documented. A total of 9893 (14%) had reactive anti-HCV tests of 72 745 patients tested, 5109 (52%) of these had HCV RNA tested, and 4224 (43%) were HCV RNA detectable. A total of 2738 (65%) of 4224 with detectable RNA were engaged in care, 909 (22%) were prescribed antiviral therapy, and 354 (8%) achieved SVR. Factors associated with HCV treatment included cirrhosis, tobacco use, depression, diabetes, obesity, alcohol use, male gender, black race and Medicare insurance. Uninsured patients were significantly less likely to be prescribed HCV treatment. In conclusion, using EHR data, we identified high anti-HCV prevalence and noted gaps in HCV RNA testing, linkage to care and treatment. The EHR can be used to evaluate the effectiveness of targeted interventions to overcome these gaps.

Evaluation of the Performance of Algorithms That Use Serial Hepatitis C RNA Tests to Predict Treatment Initiation and Sustained Virological Response Among Patients Infected With Hepatitis C Virus.

The structure of electronic medical record data prevents easy population-level monitoring of hepatitis C virus (HCV) treatment uptake and cure. Using an HCV registry from a public hospital system in Atlanta, Georgia, we developed multiple algorithms that use serial HCV RNA test results as proxy measures for initiation of direct-acting antiviral (DAA) treatment and sustained virological response (SVR). We calculated sensitivity and positive predictive values (PPVs) by comparing the algorithms with the DAA initiation and SVR results from the registry. From December 2013 to August 2016, 1,807 persons actively infected with HCV were identified in the registry. Of those, 698 initiated DAA treatment on the basis of medical record abstraction; of 442 patients with treatment start and/or end dates, 314 had documented SVR. Treatment algorithm 2 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results) and treatment algorithm 5 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results >6 weeks apart) had the highest sensitivity (87% and 85%, respectively) and PPV (80% and 82%, respectively) combinations. Four SVR algorithms relied on fulfilling treatment algorithm definitions and having an undetectable HCV RNA test result ≥12 weeks after the last HCV RNA result; sensitivity for all 4 algorithms was 79%, and PPV was 92%-93%. Algorithms using serial quantitative HCV RNA results can serve as proxy measures for evaluating population-level DAA treatment and SVR outcomes.

Testing for Hepatitis C During Pregnancy Among Persons With Medicaid and Commercial Insurance: Cohort Study.

BACKGROUND: The reported incidence of acute hepatitis C virus (HCV) infection is increasing among persons of childbearing age in the United States. Infants born to pregnant persons with HCV infection are at risk for perinatal HCV acquisition. In 2020, the United States Preventive Services Task Force and Centers for Disease Control and Prevention recommended that all pregnant persons be screened during each pregnancy for hepatitis C. However, there are limited data on trends in hepatitis C testing during pregnancy. OBJECTIVE: We estimated hepatitis C testing rates in a large cohort of patients with Medicaid and commercial insurance who gave birth during 2015-2019 and described demographic and risk-based factors associated with testing. METHODS: Medicaid and commercial insurance claims for patients aged 15-44 years and who gave birth between 2015 and 2019 were included. Birth claims were identified using procedure and diagnosis codes for vaginal or cesarean delivery. Hepatitis C testing was defined as an insurance claim during the 42 weeks before delivery. Testing rates were calculated among patients who delivered and among the subset of patients who were continuously enrolled for 42 weeks before delivery. We also compared the timing of testing relative to delivery among patients with commercial or Medicaid insurance. Multivariable logistic regression was used to identify factors associated with testing. RESULTS: Among 1,142,770 Medicaid patients and 1,207,132 commercially insured patients, 175,223 (15.3%) and 221,436 (18.3%) were tested for hepatitis C during pregnancy, respectively. Testing rates were 89,730 (21.8%) and 187,819 (21.9%) among continuously enrolled Medicaid and commercially insured patients, respectively. Rates increased from 2015 through 2019 among Medicaid (from 20,758/108,332, 19.2% to 13,971/52,330, 26.8%) and commercially insured patients (from 38,308/211,555, 18.1% to 39,152/139,972, 28%), respectively. Among Medicaid patients, non-Hispanic Black (odds ratio 0.73, 95% CI 0.71-0.74) and Hispanic (odds ratio 0.53, 95% CI 0.51-0.56) race or ethnicity were associated with lower odds of testing. Opioid use disorder, HIV infection, and high-risk pregnancy were associated with higher odds of testing in both Medicaid and commercially insured patients. CONCLUSIONS: Hepatitis C testing during pregnancy increased from 2015 through 2019 among patients with Medicaid and commercial insurance, although tremendous opportunity for improvement remains. Interventions to increase testing among pregnant persons are needed.

Hepatitis C Virus Testing During Pregnancy After Universal Screening Recommendations.

The study evaluates the effect of the 2020 Centers for Disease Control and Prevention and U.S. Preventive Services Task Force recommendations on hepatitis C virus (HCV) screening among pregnant persons nationally and by health insurance type. The study included 5,048,428 pregnant persons aged 15-44 years with either Medicaid or commercial health insurance who had obstetric panel testing performed by Quest Diagnostics, January 2011-June 2021. Antibody screening for HCV infection increased before and accelerated after the updated recommendations in early 2020. Disparities in HCV testing by health insurance status were substantial over the entire study period. Despite substantial progress in the proportion of pregnant persons screened for HCV infection, current testing rates fall short of universal recommendations.

Hepatitis C Treatment Among Commercially or Medicaid-Insured Individuals, 2014-2018.

INTRODUCTION: The proportion of individuals infected with hepatitis C virus that receive direct-acting antiviral treatment is unclear. METHODS: The proportion of commercially or Medicaid-insured patients receiving hepatitis C virus treatment was estimated using administrative claims data obtained from MarketScan and Multi-State Medicaid obtained on January 6, 2020. Validated algorithms derived from standardized procedures and International Classification of Diseases diagnosis codes were used to identify enrollees with chronic hepatitis C; analysis (performed November 30, 2020) was restricted to adults continuously enrolled with prescription drug coverage for >6 months before and after their index hepatitis C viral load test claim date from January 2014 through December 2018. Prescription drug claims using National Drug Codes were used for hepatitis C virus drugs. The proportion of treated patients by demographic and clinical characteristics was described, and associations with treatment were modeled using multivariable-adjusted hazard ratios and 95% CIs by insurance status. RESULTS: Of patients with chronic hepatitis C, 12,090 of 17,562 (69%) with commercial insurance and 8,112 of 27,328 (30%) with Medicaid were treated. Commercially insured patients with opioid use disorder (hazard ratio=0.78, 95% CI=0.72, 0.85), alcohol use disorder (hazard ratio=0.85, 95% CI=0.79, 0.91), severe mental illness (hazard ratio=0.92, 95% CI=0.87, 0.98), chronic kidney disease (hazard ratio=0.75, 95% CI=0.69, 0.82), or HIV infection (hazard ratio=0.74, 95% CI=0.66, 0.82) were less likely to be treated. Medicaid patients with opioid (hazard ratio=0.64, 95% CI=0.61, 0.68) or alcohol use disorders (hazard ratio=0.83, 95% CI=0.79, 0.88) were less likely to be treated. CONCLUSIONS: Hepatitis C virus treatment gaps were identified using administrative claims data among patients with commercial and Medicaid insurance.

Decreases in Hepatitis C Testing and Treatment During the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic has disrupted healthcare services, reducing opportunities to conduct routine hepatitis C virus antibody screening, clinical care, and treatment. Therefore, people living with undiagnosed hepatitis C virus during the pandemic may later become identified at more advanced stages of the disease, leading to higher morbidity and mortality rates. Further, unidentified hepatitis C virus-infected individuals may continue to unknowingly transmit the virus to others. METHODS: To assess the impact of the COVID-19 pandemic, data were evaluated from a large national reference clinical laboratory and from national estimates of dispensed prescriptions for hepatitis C virus treatment. Investigators estimated the average number of hepatitis C virus antibody tests, hepatitis C virus antibody-positive test results, and hepatitis C virus RNA-positive test results by month in January-July for 2018 and 2019, compared with the same months in 2020. To assess the impact of hepatitis C virus treatment, dispensed hepatitis C virus direct-acting antiretroviral medications were examined for the same time periods. Statistical analyses of trends were performed using negative binomial models. RESULTS: Compared with the 2018 and 2019 months, hepatitis C virus antibody testing volume decreased 59% during April 2020 and rebounded to a 6% reduction in July 2020. The number of hepatitis C virus RNA-positive results fell by 62% in March 2020 and remained 39% below the baseline by July 2020. For hepatitis C virus treatment, prescriptions decreased 43% in May, 37% in June, and 38% in July relative to the corresponding months in 2018 and 2019. CONCLUSIONS: During the COVID-19 pandemic, continued public health messaging, interventions and outreach programs to restore hepatitis C virus testing and treatment to prepandemic levels, and maintenance of public health efforts to eliminate hepatitis C infections remain important.

The hepatitis B care cascade using administrative claims data, 2016.

OBJECTIVES: Monitoring care and treatment for persons with chronic hepatitis B (CHB) is essential for demonstrating progress in achieving national elimination goals. We sought to evaluate insurance claims data as a source for monitoring progression along the CHB care cascade. STUDY DESIGN: Longitudinal evaluation from diagnosis to treatment among commercially insured enrollees with CHB. METHODS: We used standardized procedure and diagnosis codes to identify enrollees (≥ 18 years) with CHB in large insurance claims databases to describe the CHB care cascade from 2008 to 2016. Linkage to care was defined as procedure codes for liver fibrosis assessment (alanine aminotransferase in conjunction with either hepatitis B virus DNA or hepatitis B e-antigen) more than 12 months after CHB diagnosis. Treatment was defined as a claim for any CHB prescription. We analyzed factors associated with linkage to care and treatment using unadjusted logistic regression and evaluated rates of diagnosis, linkage to care, and treatment over time. RESULTS: Of 16,644 individuals with CHB, 6004 (36%) were linked to care and 2926 (18%) were treated. Persons coinfected with HIV (odds ratio [OR], 0.46; 95% CI, 0.36-0.59) or hepatitis C (OR, 0.50; 95% CI, 0.34-0.73) were less likely to be linked to care, and persons coinfected with HIV (OR, 0.29; 95% CI, 0.19-0.44) were less likely to be treated. From 2009 to 2015, there was a significant decrease in CHB diagnoses but no change in the proportion linked to care and treatment. CONCLUSIONS: We identified gaps in linkage to care and treatment in commercially insured adults with CHB.

Hepatitis B testing, care linkage, and vaccination coverage within a registry of hepatitis C infected patients.

BACKGROUND: Hepatitis B virus (HBV) infection testing among persons with hepatitis C virus (HCV) infection is necessary to appropriately care for these patients, yet uptake of HBV testing and vaccination in this population is suboptimal. METHODS: In a retrospective cohort analysis, we describe the prevalence of hepatitis B testing, linkage to hepatitis B care, and hepatitis B vaccination in patients with HCV infection within a large urban safety-net health system. Using a registry of HCV-infected patients with patient-level electronic health record data, that included demographic, clinical, and laboratory information from 2004 to 2016 from Grady Health System in Atlanta, GA, we describe (1) The prevalence of hepatitis B testing (hepatitis B surface antigen [HBsAg], core antibody [anti-HBc], surface antibody [anti-HBs]); (2) The proportion of HBsAg-positive persons receiving HBV DNA and e-antigen (HBeAg) as indicators for linkage to hepatitis B-directed care; and (3) The proportion of persons receiving hepatitis B vaccine. RESULTS: Of 4224 HCV-infected patients, 3629 (86%) had test results for HBsAg and 43 (1.2%) were HBsAg-positive. Of 2342 (55%) with test results for all three HBV serological markers, median age was 60 years, 67% were male, and 83% were African-American, 789 (34%) anti-HBc positive only, 678 (29%) anti-HBc/anti-HBs positive, 190 (8.1%) anti-HBs positive only, and 642 (27%) were HBV-susceptible. Of HBsAg-positive patients, 21% received HBV DNA and 40% HBeAg testing. The proportion of HBV-susceptible patients receiving at least 1 dose of hepatitis B vaccine was 322/642 (50%). CONCLUSIONS: In a large cohort of HCV-infected patients, we found a high prevalence of current or past HBV infection, but there were gaps in complete hepatitis B testing, hepatitis B-directed care, and hepatitis B vaccination. Strategies are needed to increase hepatitis B testing, linkage to care, and administration of the hepatitis B vaccine for HCV-infected persons in this healthcare system.