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Harvoni effective for elderly with HCV genotype 1
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Elderly adults with hepatitis C virus genotype 1 infection treated with Harvoni experienced high sustained virologic response, according to results from a pooled analysis.
Sammy Saab, MD, MPH, professor of medicine and surgery, assistant professor of nursing and head of Outcomes Research in Hepatology at the David Geffen School of Medicine at UCLA, and colleagues evaluated efficacy and safety data from 2,293 adults treated with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) enrolled in four phase 3 clinical trials: ION-1, ION-2, ION-3 and GS-US-337-0113. Twelve percent (n = 264) of the patients were older than 65 years. The analysis included patients who were treatment-naive, treatment-experienced, with and without cirrhosis and aged younger and older than 65 years.
“Given the aging population of patients with HCV and the increased efficacy of [ledipasvir/sofosbuvir] over prior antiviral therapeutic regimens, we compared the efficacy, safety and tolerability of this combination between subjects below and above 65 years of age,” Saab and colleagues wrote.
The overall SVR12 rate of all patients treated with ledipasvir/sofosbuvir with or without ribavirin was 97%. The SVR12 rate was slightly greater in patients aged older than 65 years (98%; 95% CI, 95-99) compared with younger patients (97%; 95% CI, 96-98). In those who were treatment-naive, both elderly and younger patients experienced the same SVR12 (97%). For treatment-experienced patients, SVR12 for those aged younger than 65 years was 98% vs. 99% in those aged older than 65 years.
Seventy-eight percent of patients aged younger than 65 years experienced at least one adverse event compared with 80% of patients aged older than 65 years. Common adverse events included fatigue and headache in both age groups, with or without ribavirin treatment. In the younger cohort, 2.4% experienced a serious adverse event compared with 3% of older patients. Both groups of patients had a 1% discontinuation rate due to an adverse event.
“Whereas in the past, age may have been a negative predictor of SVR and associated with increased [adverse events], the results of this study suggest that [ledipasvir/sofosbuvir] is an effective, tolerable and safe treatment option for elderly patients with chronic HCV,” the researchers concluded. “Elderly patients should not be denied therapy based on an expected lower SVR rate.” – by Melinda Stevens
- Reference:
- Saab S, et al. Hepatology. 2016;doi:10.1002/hep.28425.
Disclosure: Saab reports advising, consulting, owning stock and serving on the speakers bureau for AbbVie, Bristol-Myers Squibb and Gilead Sciences. Please see the full study for all other researchers’ relevant financial disclosures.