HCV Cure Rates in HIV Patients, Lower in Real-World than in Clinical Trials

Hepatitis C virus (HCV) cure when using direct-acting antiviral (DAA) agents in human immunodeficiency virus (HIV)-coinfected patients is lower in real-world settings than when patients are enrolled in clinical trials, a new study has found.

Seetha Lakshmi, MD, Jackson Memorial Hospital, Miami, Florida, and colleagues published the results of their study in the American Journal of Managed Care.

“Achieving cure (defined by SVR12 [sustained virologic response at week 12 post-treatment] in this study) was closely associated with attendance at follow-up clinic visits and to the use of an integrase-based HIV regimen compared with non—integrase-based regimens such as NNRTI [non-nucleoside reverse transcriptase inhibitor] or protease inhibitors,” the authors write.

In patients with chronic HCV infection, coinfection with HIV is known to accelerate the progression of hepatic fibrosis and result in more aggressive liver disease. Although interferon (IFN)-based regimens have traditionally been a longstanding backbone of therapy for chronic HCV infection, studies have shown that a combination of IFN and ribavirin (RBV) for HCV led to lower SVR rates in patients coinfected with HIV than in those without HIV.

However, the use of direct-acting antiviral (DAA) agents has produced excellent HCV cure rates in HIV-coinfected patients in clinical trials that included strict follow-up. Indeed, in one study (PHOTON-1), SVR12 rates up to 94% were reported in coinfected patients.

Nevertheless, according to the authors, “data on rates of HCV cure with the use of DAAs in patients coinfected with HIV/HCV in real-world settings are lacking.” Dr. Lakshmi and colleagues therefore conducted a retrospective cohort study to further examine the real-world effectiveness associated with DAA therapy in patients coinfected with HIV/HCV, and also to identify predictors of cure in this patient population.

They analyzed medical data from 84 adult HIV/HCV-coinfected patients who initiated and completed DAA therapy for HCV between January 1, 2014, and June 30, 2015, at 3 large outpatient settings in south Florida. The most commonly used regimens were sofosbuvir/ledipasvir (40%) and simeprevir/sofosbuvir (30%).

Dr. Lakshmi and colleagues found that HCV cure rates in the real-world setting were lower than those seen in clinical trials. Among the 84 patients in the real-world study, 83.3% achieved HCV cure (SVR12), 11.9% relapsed, and 2.3% experienced virological breakthrough.

They also found that attendance at follow-up clinic visits and use of an integrase-based antiretroviral regimen were associated with HCV cure. “This may be related to the fact that integrase inhibitors have fewer drug-drug interactions with HCV medications (hence lower chances of sub therapeutic drug levels for HCV) than do NNRTIs or protease inhibitors,” the authors write. “Treatment of HCV in the HIV-infected population is challenging due to accelerated liver disease, concomitant comorbidities, and difficulties managing HCV-HIV drug-drug interactions.”

The critical importance of long-term adherence to care has previously been described in HIV-monoinfected individuals, in whom timely linkage to health care and increased visit frequency have been shown to be associated with faster time to HIV viral suppression.

“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,” the authors conclude.

Dr. Parry graduated from the University of Liverpool, England in 1997 and is a board-certified veterinary pathologist. After 13 years working in academia, she founded Midwest Veterinary Pathology, LLC where she now works as a private consultant. She is passionate about veterinary education and serves on the Indiana Veterinary Medical Association’s Continuing Education Committee. She regularly writes continuing education articles for veterinary organizations and journals, and has also served on the American College of Veterinary Pathologists’ Examination Committee and Education Committee.