Direct-acting Antivirals Effective in Older Patients with Hepatitis C

Treatment of hepatitis C virus (HCV) with sofosbuvir-based direct acting antivirals (DAAs) was recently found as effective and well-tolerated in elderly patients as it was in younger patients in previous development trials.

Sanjaya Satapathy, MD, Department of Surgery, University of Tennessee Health Science Center, and a team of researchers pointed out that although approximately 70% of HCV cases are in adults born between 1945 and 1965, the treatment of HCV in the most elderly patients has not been well studied.

"Historically, older patients have been underrepresented in studies evaluating the efficacy and safety of HCV treatment due to poor tolerability and suboptimal response to interferon-based regimens," the researchers wrote.

Satapathy and colleagues conducted a retrospective review of patients 70 years and older to determine their course while receiving a DAA treatment without interferon.

They identified 25 patients treated at a hospital-based liver disease clinic with mean age 73.2 years (range 70 to 81 years). The majority of patients were female (76%) and African-American (56%), with all having HCV genotype 1.

Seventeen patients (68%) were cirrhotic at time of treatment, with all but one having compensated condition. The most common co-morbidities were hypertension (84%), diabetes mellitus (36%) and chronic kidney disease stage 3 (32%). Four of the patients had received liver transplants.

A regimen of ledipasvir/sofosbuvir (LDV/SOF) was used in 17 patients, 4 patients received simeprevir/sofosbuvir (SIM/SOF), and 4 received SIM/SOF plus ribavirin (RBV). Of the LDV/SOF group, 8 were treated for 24 weeks and 9 for 12 weeks.

All but one patient (96%) achieved sustained virologic response (SVR) at completion of treatment. he one patient not responsive to treatment, with SIM/SOF, had previously failed interferon-based therapies and had received liver transplant, presenting recurrent GT1a infection with allograft cirrhosis.

All patients completed their treatment regimens without interruption of therapy. Two of the 4 patients receiving RBV experienced a drop in hemoglobin of greater than 2g/dL from baseline, and RBV was discontinued in one patient. There were no serious adverse effects, with 7 patients reporting mild adverse events such as headache or fatigue.

The finding that DAA treatments are effective and well tolerated in elderly patients is particularly important, Satapathy and colleagues noted, given the increased risk for cirrhosis and hepatocelluar carcinoma with advanced age, and the likelihood of longer durations of HCV infection that are associated with fibrosis progression and related complications.

"Although age was historically considered a negative predictor of cure with interferon-based therapies, it should no longer be viewed as a barrier to treatment with the newer DAAs," the researchers wrote.

The study, "Efficacy and Safety of Sofosbuvir-Based Direct Acting Antivirals for Hepatitis C in Septuagenarians and Octogenarians," was published online in the June issue of the Journal of Clinical and Experimental Hepatology.