CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

601 HEPATITIS C TREATMENT UPTAKE AMONG INSURED HIV/HCV- COINFECTED PATIENTS

Jennifer O. Lam 1 , Leo Hurley 1 , Scott Chamberland 1 , Jamila Champsi 1 , Laura C. Gittleman 1 , Daniel G. Korn 1 , Jennifer B. Lai 1 , Charles P. Quesenberry 1 , Joanna Ready 1 , Varun Saxena 1 , Suk Seo 1 , David J. Witt 1 , Michael J. Silverberg 1 , Julia L. Marcus 2 1 Kaiser Permanente, Oakland, CA, USA, 2 Harvard University, Boston, MA, USA Background: Patients coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are prioritized for HCV treatment because of their elevated risk of liver disease. However, the high cost of direct-acting antivirals (DAAs) for the treatment of HCV infection may contribute to disparities in access and initiation. Methods: Using a retrospective cohort design, we measured factors associated with DAA initiation among HIV/HCV-coinfected patients at Kaiser Permanente Northern California (KPNC) from October 2014 (when DAAs became widely used in KPNC) through December 2016. Potential predictors of DAA initiation were demographic characteristics, including age, sex, race/ethnicity, census- based neighborhood deprivation index (NDI; proxy for socioeconomic status); behavioral factors, including HIV risk, alcohol use, smoking, and drug abuse diagnosis; economic factors, including insurance type and individual out-of- pocket maximum healthcare costs; and clinical factors, including HCV genotype, advanced fibrosis (based on most recent Fibroscan if available, otherwise FIB-4), prior HCV treatment, hepatitis B virus (HBV) infection, baseline CD4 count, and baseline HIV RNA level. Adjusted rate ratios (aRRs) were obtained from multivariable Poisson regression models. Results: Among 555 HIV/HCV-coinfected patients, 232 (41.8%) initiated DAAs (90% on ledipasvir/sofosbuvir). There were no significant differences in DAA initiation by race/ethnicity, NDI, maximum out-of-pocket healthcare costs, HIV risk, alcohol use, smoking, HBV infection, or HIV RNA levels. Factors associated with initiation of DAAs included male sex (aRR 1.86, 95% confidence interval [CI]: 1.01-3.33), ages 60-69 years (compared with <50 years, aRR 1.60, 95% CI: 1.07-2.38), advanced fibrosis (aRR 1.68, 95% CI: 1.14-2.50), HCV genotype 1 (aRR 2.45, 95% CI: 1.65-3.64), and no prior HCV treatment (aRR 2.10, 95% CI: 1.47-3.02). Factors associated with reduced DAA initiation included CD4 <200 cells/µL (compared with ≥500 cells/µL, aRR 0.35, 95% CI: 0.16-0.79), Medicare enrollment (compared with commercial insurance, aRR 0.63, 95% CI: 0.41-0.95), and drug abuse diagnosis (aRR 0.66, 95% CI: 0.47-0.92). Conclusion: We found little evidence of racial/ethnic or socioeconomic disparities in initiation of DAAs among HIV/HCV-coinfected patients during the initial years of DAA availability within KPNC. Efforts are needed to increase DAA uptake among women, younger patients, Medicare enrollees, and those with drug abuse diagnoses.

600 INCREASING INCIDENCE OF DENIAL OF DAA THERAPY FOR CHRONIC HCV BY INSURANCE TYPE Charitha Gowda 1 , Stephen Lott 2 , Matthew Grigorian 3 , Dena M. Carbonari 4 , M. Elle Saine 4 , Stacey Trooskin 5 , Jason A. Roy 4 , Jay Kostman 5 , Paul N. Urick 3 , Vincent Lo Re 4 1 The Ohio State University, Columbus, OH, USA, 2 University of Michigan, Ann Arbor, MI, USA, 3 EnvoyHealth, Flint, MI, USA, 4 University of Pennsylvania, Philadelphia, PA, USA, 5 Philadelphia FIGHT, Philadephia, PA, USA Background: The high costs of direct-acting antiviral (DAA) regimens to treat chronic hepatitis C virus (HCV) infection have led public and private insurers to restrict access to these medications. Studies conducted after their release showed that denial of DAA regimens by insurers was common, but these analyses were not nationally representative and evaluated access during initial availability. Given the advent of new DAAs, perceived relaxation of treatment restrictions, and public health focus on HCV elimination, we evaluated changes in the incidence of insurer denial of DAA therapy over time and by type of insurance within a national specialty pharmacy. Methods: We conducted a prospective cohort study among patients who had a DAA prescription submitted between January 1, 2016 and April 30, 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services to patients across the United States. The main outcome was absolute denial of DAA prescription, defined as lack of approval of any DAA fill by the insurer. The status of all prescriptions with insurers was ascertained through August 31, 2017. Insurers’ requests for alternative DAA regimens due to formulary restrictions were not recorded as absolute denials. We calculated the incidence of absolute denial of DAA prescription, overall and by type of insurance (Medicaid, Medicare, or commercial), for the 16-month study period and for each quarter. Results: Among 9,025 patients from 45 states who were prescribed a DAA regimen (4,702 covered by Medicaid; 1,821 by Medicare; 2,502 by commercial insurance), 3,200 (35.5%; 95% CI, 34.5-36.5%) received an absolute denial of their treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than by Medicaid (34.5%; p<0.001) or Medicare (14.7%; p<0.001). The incidence of absolute denial increased across each quarter of the 16-month study period, overall (27.7% in the first quarter to 43.8% in the last quarter; test for trend, p<0.001) and for each type of insurance (test for trend, p<0.001 for each type; see Figure). Conclusion: Despite the availability of new DAA regimens and changes in restrictions to these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of type of insurance. The influence of liver fibrosis stage, substance use, and type of prescriber on DAA denials requires further investigation. To achieve the goal of HCV elimination, access to antiviral treatment must be improved.

Poster Abstracts

CROI 2018 221