The American Journal of Managed Care Special Issue: HCV
Improving HCV Cure Rates in HIV-Coinfected Patients - A Real-World Perspective
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
- 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.
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.
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.
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.