Ledipasvir-sofosbuvir combo safe, effective for elderly hep C patients

Last Updated: 2016-03-18

By Lorraine L Janeczko

NEW YORK (Reuters Health) - The combination of ledipasvir and sofosbuvir (LDV/SOF) is safe, effective and well tolerated in people over 65 who have genotype 1 hepatitis C, researchers have found.

"This study, which is the largest analysis ever done in the population over 65, found that the combination of the NS5A inhibitor ledipasvir with the nucleotide polymerase inhibitor sofosbuvir for hepatitis C is not only highly effective but is also safe and tolerable," Dr. Sammy Saab from the David Geffen School of Medicine at the University of California, Los Angeles, told Reuters Health.

Dr. Saab has multiple financial ties, including stock ownership, to Gilead Sciences, which makes LDV/SOF.

He said he and his team had been surprised by their findings.

"Historically, every single study has shown a dropoff in the cure rate between young and elderly patients. The elderly were not being treated for hepatitis C because the side effects were so severe," Dr. Saab said.

"These results present a wonderful opportunity for patients who have been denied therapy to be cured with pills that are safe, effective and tolerable, so elderly patients are no longer a special population with diminished cure rates," he added. "This is very important because most people with hepatitis C are aging baby boomers"

Dr. Saab and colleagues analyzed data from four open-label phase 3 clinical trials that evaluated the safety and efficacy of LDV/SOF to treat genotype 1 chronic hepatitis C virus.

They analyzed sustained virological response at 12 weeks, treatment-emergent adverse events, and graded laboratory abnormalities, comparing patients under 65 years of age with those 65 and above.

Eligible participants were adults with chronic genotype 1 hepatitis C viral infection in the U.S., Europe, and Japan. Of the nearly 2,300 patients enrolled in the trials, 12% were 65 or older. The rate of compensated cirrhosis was 12% in the younger group and 20% in the older group.

At 12 weeks, sustained virological response was reached by 97% patients under 65 and 98% 65 and above, the researchers report in Hepatology online February 22.

The most common adverse events in both age groups that occurred in 10% or more of patients were headache and fatigue. The rate of study discontinuation due to adverse events was 1% in both age groups.

"I think we are at a pivotal point in treating hepatitis C and achieving virologic cure. After many years of struggle marred by side effects and lack of efficacy, it is gratifying and exciting to be able to offer these therapies to patients, including those over 65, without too much concern about the safety profile," said Dr. Saro Khemichian, assistant professor of clinical medicine and chief of the hepatitis treatment center at the Keck School of Medicine of the University of Southern California in Los Angeles.

"This study is very important because most people with hepatitis C were born between 1945 and 1965. We know that the longer a person has hepatitis C infection the higher the likelihood that they will develop liver cirrhosis and associated complications," Dr. Khemichian, who was not involved in the study, told Reuters Health by email.

Dr. Khemichian also has a financial relationship with Gilead.

The authors acknowledged limitations to their study, including its retrospective nature, its broad definition of "elderly," and the differential distribution of genotypes 1a and 1b between non-Asian and Asian elderly patients.

All authors except one declared financial relationships with Gilead, including employment.

SOURCE: bit.ly/1R2QLdP

Hepatology 2016.