Gauging Clinical, Cost Impact of All-Oral DAAs on Hepatitis C

Haesuk Park, PhD

A new analysis gauges the impact of all-oral direct-acting antivirals (DAAs) on the clinical and economic outcomes of hepatitis C virus (HCV) in the 4 years since the first of these treatments was approved for marketing in the US.

Haesuk Park, PhD, Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL and colleagues determined that, in this short term, all-oral DAA treatment of HCV was associated with a decreased risk of developing hepatocellular carcinoma (HCC) and decompensated cirrhosis (DCC) and a reduction in healthcare costs.

"We do realize that the high, upfront costs of the medications can create a short-term negative impact on payers' budgets," Park told MD Magazine®, "but by knowing the long-term costs and cost savings, payers should now be able to address this cost barrier instead of just looking at drug costs in a simple budgetary manner."

The investigators conducted a retrospective cohort analysis with over 26,000 patients newly diagnosed with HCV, from the Truven Health MarketScan Database (2012-2016). All-oral DAA treatment had been provided to 30% of these patients, and their course and outcomes were compared to the 70% who did not receive any treatment.

Linda Henry, PhD, a co-author of the study, of the Pharmaceutical Outcomes and Policy at the University of Florida, commented on the large proportion of patients in this population who did not receive treatment, indicating that it is still early to characterize the extent that these essentially curative treatments are utilized.

"One reason for this is the lag time between when the data are analyzed and published, which may not allow for a good approximately on whether we are making in-roads in treating all patients, especially in the rapidly changing HCV treatment arena," Henry said.

Several condition were more prevalent among those not receiving DAA treatment, although the investigators do not suggest any to have been factors in not receiving treatment. These included alcohol and/or substance use disorder, hepatitis B virus infection, and alcoholic liver disease.

"There could be a number of reasons for this low number, including medication affordability, patient refusal, patients unaware of their HCV status, lack of physician knowledge on the available treatments, and healthcare insurance barriers such as prior approval or restrictions on...(eligibility for) these medications,” Henry said.

The investigators found that among the cirrhotic patients (n= 2157) 57 (2.6%) had a HCC event. The majority of HCC events (70%) occurred in patients who received no treatment, with an incidence rate of 48.9 per 1000 person-years, compared to 11.7 per 1000 person-years among those receiving the all-oral DAA treatment. After adjusting for covariates, analysis indicated that the cirrhotic patients in the DAA treatment group had a 72% decreased risk of developing HCC compared to the untreated group.

The non-cirrhotic patients treated with DAA had a 57% decreased risk for HCC compared to the untreated group.

All-oral DAA treatment also significantly reduced DCC events, with cirrhotic patients receiving treatment having a 62% of decreased risk compared to the untreated group and non-cirrhotic, treated patients having a 58% decreased risk.

The corresponding reductions in medical costs for cirrhotic patients receiving treatment compared to untreated were estimated to be $1863 in liver-related medical costs and $18,601 in all-cause costs. For non-cirrhotic patients, however the DAA treatment was associated with an increase in liver-related costs of $747, attributed to higher rate of outpatient visits than in the untreated group. The difference in all-cause costs were not statistically significantly different between treated and untreated non-cirrhotic patients.

"Since HCV is a chronic condition, offering a curative treatment provides an opportunity to slow down the progressiveness of this disease and potentially increase the health outcomes of patients and society while saving money," Park said.

The study, "Impact of All-oral Direct-acting Antivirals on Clinical and Economic Outcomes in Chronic Hepatitis C Pateints in the US," was published online in the journal Hepatology.