New Hep C Treatments Cause Adverse Effects in the Elderly

Laird Harrison

March 15, 2016

SAN FRANCISCO — Direct-acting antiviral medications can be effective in older patients with hepatitis C, but adverse reactions are common and the adjustment of other medications is often required, new research suggests.

"We need more data about these new treatments in the elderly," said Berta Pernas, from Corunna University Hospital in Spain.

"I think we can treat these patients, but caution for interactions and adverse events is required," she said here at the International Conference on Viral Hepatitis 2016.

Patients with hepatitis C who are 65 years and older present particular challenges because they progress rapidly to cirrhosis and are more likely to suffer from extrahepatic manifestations, such as fatigue and neuropsychologic disorders.

These older patients are also more likely to discontinue treatment and experience adverse events, Dr Pernas reported. And rates of sustained viral response resulting from interferon-based therapies are lower in older patients than in younger patients.

Although age does not seem to influence the effectiveness of direct-acting antiviral drugs, not much research has been conducted on the use of this newer class of medication in older patients. In fact, some of the pivotal trials deliberately excluded the oldest patients, she pointed out.

To see whether this population could benefit from direct-acting antivirals, Dr Pernas and her colleagues followed all patients 65 years and older who were treated for hepatitis C at Corunna University Hospital and Hospital Alvaro Cunqueiro from August 2012 to October 2015.

The average age of the 121 patients was 72.6 years, and almost 53% were women.

More than 95% of the study cohort was infected with genotype 1 hepatitis C virus, and the average RNA viral load at baseline was 6.52 IU/mL. Two-thirds of the patients had stage 4 fibrosis or cirrhosis, and more than 20% had a fibrosis score of 3.

Direct-Acting Antivirals in Older Patients

More than 85% of the patients were taking other medications, including antihypertensives, proton-pump inhibitors, antidiabetic medication, benzodiazepines, and statins.

Concern about possible drug interactions led physicians to modify prescriptions in one-third of the patients. In most cases, physicians asked patients to discontinue the previously prescribed medication before beginning the hepatitis treatment, Dr Pernas said, but some changes were made in response to symptoms that occurred during treatment.

In the study cohort, 3.5% of the patients had received previous treatment and experienced a virologic breakthrough, 6.6% had only a partial response, 11.6% experienced a relapse, and 17.4% were classified as null responders. The remaining patients had not been previously treated for hepatitis C infection.

The most common of the 12 treatment regimens used in the study were the combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak, AbbVie) with or without ribavirin, and the combination of ledipasvir and sofosbuvir (Harvoni Gilead Sciences) with or without ribavirin.

Of the 61.2% of the patients who received ribavirin, almost half had their dose reduced during treatment. For 82.6% of the patients, the treatment period was 12 weeks; for most of the other patients, it was 24 weeks.

The treatments proved effective, and 95.1% of the patients achieved a sustained viral response. However, 43.8% experienced adverse events, including two cases of hepatic decompensation (one involving encephalopathy and the other hydropic decompensation). Only 2.4% of patients discontinued treatment.

Table. Adverse Events Experienced During Treatment

Event Percent
Fatigue 37.2
Anemia 34.7
Dry mucous 14.9
Elevated bilirubin 10.7
Insomnia 3.3
Irritability 2.5

These findings show that clinicians must individualize treatment in this population, taking into consideration medications, comorbidities, disease stage, and genotype of the virus. "As physicians, we can choose the best option for each patient," Dr Pernas explained.

This study provides useful guidance for the treatment of older patients with hepatitis C, said session moderator Daniel Fierer, MD, from the Icahn School of Medicine at Mount Sinai in New York City.

"It is quite reassuring that they respond well," he told Medscape Medical News.

The findings highlight the importance of fine-tuning medications to prevent adverse interactions, he pointed out. For example, you do not want to decrease a patient's stomach acid when prescribing ledipasvir and sofosbuvir.

Dr Pernas has disclosed no relevant financial relationships. Dr Fierer reports that he holds stock in Gilead Sciences.

International Conference on Viral Hepatitis (ICVH) 2016. Presented March 14, 2016.

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