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The American Journal of Managed Care Special Issue: HCV
Real-World Outcomes of Ledipasvir/Sofosbuvir in Treatment-Naïve Patients With Hepatitis C
Zobair M. Younossi, MD, MPH, FACG, AGAF, FAASLD; Haesuk Park, PhD; Stuart C. Gordon, MD; John R. Ferguson; Aijaz Ahmed, MD; Douglas Dieterich, MD; and Sammy Saab, MD, MPH
Sofosbuvir Initial Therapy Abandonment and Manufacturer Coupons in a Commercially Insured Population
Taruja D. Karmarkar, MHS; Catherine I. Starner, PharmD; Yang Qiu, MS; Kirsten Tiberg, RPh; and Patrick P. Gleason, PharmD
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Improving HCV Cure Rates in HIV-Coinfected Patients - A Real-World Perspective
Seetha Lakshmi, MD; Maria Alcaide, MD; Ana M Palacio, MD, MPH; Mohammed Shaikhomer, MD; Abigail L Alexander, MS; Genevieve Gill-Wiehl, BA; Aman Pandey, BS; Kunal Patel, BS; Dushyantha Jayaweera, MD; a
A Way Out of the Dismal Arithmetic of Hepatitis C Treatment
Jay Bhattacharya, MD, PhD, Center for Primary Care and Outcomes Research, Stanford University School of Medicine; Guest Editor-in-Chief for the HCV special issue of The American Journal of Managed
Value of Expanding HCV Screening and Treatment Policies in the United States
Mark T. Linthicum, MPP; Yuri Sanchez Gonzalez, PhD; Karen Mulligan, PhD; Gigi A. Moreno, PhD; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Darius N. Lakdawalla, PhD; Brian R. Edli
The Wider Public Health Value of HCV Treatment Accrued by Liver Transplant Recipients
Anupam B. Jena, MD, PhD; Warren Stevens, PhD; Yuri Sanchez Gonzalez, PhD; Steven E. Marx, PharmD; Timothy Juday, PhD; Darius N. Lakdawalla, PhD; and Tomas J. Philipson, PhD
Costs and Spillover Effects of Private Insurers' Coverage of Hepatitis C Treatment
Gigi A. Moreno, PhD; Karen Mulligan, PhD; Caroline Huber, MPH; Mark T. Linthicum, MPP; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Yuri Sanchez Gonzalez, PhD; Ron Brookmeyer, PhD
Coverage for Hepatitis C Drugs in Medicare Part D
Jeah Kyoungrae Jung, PhD; Roger Feldman, PhD; Chelim Cheong, PhD; Ping Du, MD, PhD; and Douglas Leslie, PhD

Improving HCV Cure Rates in HIV-Coinfected Patients - A Real-World Perspective

Seetha Lakshmi, MD; Maria Alcaide, MD; Ana M Palacio, MD, MPH; Mohammed Shaikhomer, MD; Abigail L Alexander, MS; Genevieve Gill-Wiehl, BA; Aman Pandey, BS; Kunal Patel, BS; Dushyantha Jayaweera, MD; a
The authors examine real-world hepatitis C virus cure rates with direct-acting antivirals among patients coinfected with HIV.

ABSTRACT

Objectives: To study rates and predictors of hepatitis C virus (HCV) cure among human immunodeficiency virus (HIV)/HCV-coinfected patients, and then to evaluate the effect of attendance at clinic visits on HCV cure.

Methods: Retrospective cohort study of adult HIV/HCV-coinfected patients who initiated and completed treatment for HCV with direct-acting antivirals (DAAs) between January 1, 2014, and June 30, 2015.

Results: Eighty-four participants reported completing treatment. The median age was 58 years (interquartile ratio, 50-66); 88% were male and 50% were black. One-third were cirrhotic and half were HCV-treatment–experienced. The most commonly used regimen was sofosbuvir/ledipasvir (40%) followed by simeprevir/sofosbuvir (30%). Cure was achieved in 83.3%, 11.9% relapsed, and 2.3% experienced virological breakthrough. Two patients (2.3%) did not complete treatment based on pill counts and follow-up visit documentation. In multivariable analysis, cure was associated with attendance at follow-up clinic visits (odds ratio [OR], 9.0; 95% CI, 2.91-163) and with use of an integrase-based HIV regimen versus other non-integrase regimens, such as non-nucleoside analogues or protease inhibitors (OR, 6.22; 95% CI 1.81-141). Age, race, genotype, presence of cirrhosis, prior HCV treatment, HCV regimen, and pre-treatment CD4 counts were not associated with cure.

Conclusions: Real-world HCV cure rates with DAAs in HCV/HIV coinfection are lower than those seen in clinical trials. Cure is associated with attendance at follow-up clinic visits and with use of an integrase-based HIV regimen. Future studies should evaluate best antiretroviral regimens, predictors of attendance at follow-up visits, impact of different monitoring protocols on medication adherence, and interventions to ensure adequate models of HIV/HCV care.

Am J Manag Care. 2016;22(5 Spec Issue No. 6):SP198-SP204

Take-Away Points
 
Clinical trials have shown excellent cure rates for hepatitis C virus (HCV) among the HIV/HCV population. We examined data for real-world cure rates of HCV and predictors of cure in this population.
  • Real-world HCV cure rates when using direct-acting antivirals (DAAs) in HIV/HCV coinfection are lower than those seen in clinical trials. 
  • Cure is associated with attendance at follow-up clinic visits and with the use of  integrase-based antiretroviral regimens, compared to non–integrase-based HIV regimens, such as non-nucleoside analogues and protease inhibitors. 
  • Future studies should evaluate best antiretroviral regimens, predictors of attendance to follow-up visits, impact of different monitoring protocols on medication adherence, and interventions to ensure adequate models of HIV/HCV care.
Globally, an estimated 30% of the 33 million people living with HIV infection also have hepatitis C virus (HCV) coinfection.1 The natural history of HCV infection is altered in the HIV-infected host: patients with coinfection are half as likely to spontaneously clear HCV viremia, tend to have higher HCV ribonucleic acid (RNA) levels, and have accelerated progression to hepatic fibrosis and decompensated liver disease.2,3 Despite the use of antiretroviral therapy, the proportion of deaths caused by HCV-related end-stage liver disease and hepatocellular carcinoma have increased in the HIV-infected population.4
 
Historically, patients coinfected with HIV/HCV who are treated with interferon and ribavirin (IFN/RBV) for HCV had lower rates of sustained virological response (SVR) than those without HIV infection.5 In contrast to the IFN/RBV treatment, the direct-acting antivirals (DAAs) have demonstrated similar rates of HCV cure in monoinfected and coinfected patients in clinical trials where strict follow-up is mandated.6,7 However, data on rates of HCV cure with the use of DAAs in patients coinfected with HIV/HCV in real-world settings are lacking.
 
Treatment of HIV/HCV coinfection poses specific challenges, as it is preferred that patients be on stable antiretroviral therapy (ART) prior to initiating HCV treatment, and that there be careful consideration of drug-drug interactions. In addition, due to the high cost of DAAs, insurance companies may have specific criteria to approve HCV treatment in the HIV-infected population. Access to care, frequent monitoring of HIV treatment, and adherence to antiretroviral therapy have been associated with faster time to HIV viral suppression and increased survival in the HIV-infected population.8,9 In real-world settings, these and other factors may be less optimal than in randomized clinical trials; therefore, we aimed to describe predictors of HCV cure among patients with HIV/HCV coinfection in 3 large urban outpatient settings. We hypothesized that real-world rates of HCV cure in the HIV-infected population are lower than those that have been described in clinical trials, and that attendance at clinical monitoring visits is associated with higher cure rates.
 
Understanding real-world data is key to inform interventions and treatment protocols and to potentially increase cure rates in the HIV/HCV-coinfected population.
 
METHODS
Study Design
This was a retrospective cohort study of adult patients coinfected with HIV/HCV receiving medical care at 3 large outpatient settings in south Florida: 1) the Miami Veterans Affairs (VA) Healthcare System serves approximately 153,000 veterans in 3 counties by operating 372 hospital beds, a community living center, and 7 satellite clinics; 2) the University of Miami Health system (UHealth) is a private academic institution operating 3 hospitals and 30 outpatient facilities serving 4 counties; and 3) the Jackson Health System (JHS), a public academic institution with 6 hospitals, 12 specialty care centers, and 2 long-term care centers, serves as a tertiary referral center for the state of Florida.
 
We reviewed medical charts of individuals with HIV/HCV coinfection who initiated and completed treatment for HCV with DAAs in any of these 3 institutions between January 1, 2014, and June 30, 2015.
 
Inclusion Criteria
All adults with HIV/HCV coinfection who initiated and completed HCV therapy with DAAs were included. HCV treatment was provided to patients 18 years or older with no evidence of active drug or alcohol abuse and who were on ART for HIV.
 


 
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