Ledipasvir/Sofosbuvir Leads to High Real-World SVR in HIV/HCV Coinfection

Issue: June 2016

SAN DIEGO — Harvoni, with or without ribavirin, yielded a 97% sustained virologic response rate in a real-world cohort of patients with genotype 1 hepatitis C virus and HIV, according to findings presented at Digestive Disease Week 2016.

Kris V. Kowdley, MD, of the Liver Care Network, Swedish Medical Center in Seattle, and colleagues, aimed to understand real-world outcomes across a heterogeneous population. The analysis included 140 patients who initiated therapy between October 2014 and March 2015. Patients were treated with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for 8 (5%), 12 (75%) or 24 (20%) weeks.

Kris V. Kowdley

The population showed heterogeneity, with 59% treated at a community site, 73% black, 46% HCV treatment-experienced and 35% with cirrhosis. They also assessed for a platelet cutoff level of less than 100k/ml and a baseline HCV RNA cutoff level of 6 million IU/ml. “We have been collecting data on age, gender, ethnicity and BMI,” Kowdley said. “One in five patients had a high viral load.”

SVR12 rates were 100% among eight patients in the 8-week group, 98% among 112 patients in the 12-week group and 97% among 30 patients in the 24-week group.

For those with cirrhosis, the SVR12 rate was 100%, regardless of treatment experience. Among non-cirrhotics, 98% of experienced patients and 100% of treatment-naive patients reached SVR12. Response was also 100% in patients with genotype 1a HCV, regardless of baseline viral load. For genotype 1b, 95% of those with a baseline viral load of less than 6 million IU/mL reached SVR12, while 100% of patients with a viral load above that threshold responded.

Response rates were 100% for patients who were treated with a proton pump inhibitor and 99% for those who were not. “We were interested to see this because have seen a lot of data for PPI use,” Kowdley said.

SVR12 was 97% among black patients and 100% among non-black patients.

Regarding predictors of response, Kowdley noted two outliers associated with a reduction in SVR. “One was platelet count less than 100,000 and one was genotype 1b,” he said. He noted, however, that the sample size of genotype 1b patients was small, and that this effect was minimal.

“In conclusion, SVR rates were greater than 97% in this real-world cohort,” Kowdley said. “Only one relapse was documented. These data suggest that LDV/SOF has similar effectiveness in real life as the results reported in the ION-4 study.”

Reference:

Dieterich D, et al. Abstract #606. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Kowdley reports associations with a number of device and pharmaceutical companies.