This article is more than 5 years old. Information may no longer be current.
NS5A RAVs may persist through 96 weeks after ledipasvir therapy
Click Here to Manage Email Alerts
VIENNA — NS5A resistance-associated variants persisted through 96 weeks in a high proportion of patients treated with ledipasvir, an NS5A inhibitor, according to data presented at the 2015 International Liver Congress.
David Wyles, MD, associate professor of medicine in the division of infectious diseases at the University of California at San Diego, and colleagues aimed to assess the persistence of RAVs in patients who previously failed on ledipasvir therapy (Gilead Sciences) without sofosbuvir in Gilead-sponsored HCV clinical studies.
All patients received ledipasvir. Fifty patients also received vedroprevir and tegobuvir (Gilead Sciences), while another 26 were treated with vedroprevir, tegobuvir, peginterferon and ribavirin.
Baseline associated RAVs were reported in 16% (12/76) of patients. At virologic failure, 99% of those patients had NS5A RAVs.
“All 16% of those baseline RAVs persisted,” Wyles said. “We are now looking at patients with emergent variants. Characterizing the nature and persistence of these RAVs can be helpful in planning treatment or retreatment regimens.”
Clinicians assessed the patient population for NS5A RAVs at baseline and follow-up at various time points through 96 weeks in an initial parent study and a registry study.
“We wanted to quantify proportion of patients with any RAV over time,” Wyles said.
Sixteen patients in the initial parent study had NS5A RAVs at baseline that persisted through 96 weeks.
Among patients with virologic failure in the parent study, these RAVs occurred in 95%.
NS5A RAVs also were reported in high proportions of patients with virologic failure in the other time points that underwent analysis:
- 97% at baseline
- 96.5% at 12 weeks
- 100% at 24 weeks
- 96% at 48 weeks
- 99% at 96 weeks
“The average number of RAVs decreased over the 96-week observation period,” Wyles said.
The RAVs at L31 and H58 were most likely to persist, he added. Regarding the nature of the variants, at baseline 98.7% of were RAVs, but by week 96, 33% were wild type.
“Patients who failed treatment with ledipasvir-containing regimens without sofosbuvir had a high prevalence of NS5A RAVs at virologic failure,” Wyles said.
For More Information:
Wyles D, et al. Abstract O059. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Wyles reports no relevant financial disclosures.