In the Journals

Daklinza-Sovaldi produces similar SVR as Epclusa for HCV genotypes 2, 3

Daklinza with Sovaldi and ribavirin produced similar rates of sustained virologic response among patients with hepatitis C genotypes 2 and 3 as those treated with Epclusa, according to a recently published study.

“Genotype 2 accounts for 11% of chronic HCV infections both worldwide and in the United States, while genotype 3 accounts for 18% of HCV infections worldwide and 9% in the United States,” Pamela S. Belperio, PharmD, BCPS, from the Department of Veterans Affairs in California, and colleagues wrote. “In difficult-to-treat populations where less evidence-based guidance may be available, real-world providers may make empiric decisions to extend treatment, add [ribavirin], or both.”

The study comprised 2,939 patients with HCV genotype 2 and 2,824 patients with genotype 3 who received either Daklinza (daclatasvir, Bristol-Myers Squibb) with Sovaldi (sofosbuvir, Gilead Sciences) or Epclusa (sofosbuvir/velpatasvir, Gilead Sciences), each treatment course potentially including ribavirin.

Sustained virologic response results were available for 94.4% of patients with HCV genotype 2 and 93% of those with genotype 3. The rates of discontinuation prior to 12 weeks were similar regardless of genotype or treatment regimen.

In the genotype 2 group, SVR rates were similar between daclatasvir/sofosbuvir and sofosbuvir/velpatasvir regardless of treatment with (88.1% vs. 89.5%) or without ribavirin (94.5% vs. 94.4%). Multivariate analysis showed that patients younger than 55 years had decreased odds for SVR (OR = 0.45; 95% CI, 0.27-0.77).

For genotype 3, SVR rates were also similar between those treated with daclatasvir/sofosbuvir and sofosbuvir/velpatasvir regardless of treatment with (88.1% vs. 86.4%) or without ribavirin (90.8% vs. 92%). Multivariate analysis showed that Fibrosis-4 index higher than 3.25 compared with an index between 1.45 and 3.25 (OR = 0.6; 95% CI, 0.43-0.84), decompensated disease (OR = 0.68; 95% CI, 0.47-0.99) and prior HCV treatment (OR = 0.51; 95% CI, 0.36-0.72) predicted decreased odds of SVR.

In the genotype 3 group, the addition of ribavirin to daclatasvir/sofosbuvir and extended treatment from 12 weeks to 24 weeks marginally increased SVR rates among patients with a FIB-4 index higher than 3.25 (90% vs 93.9%).

“Our analysis supports [daclatasvir/sofosbuvir] and [sofosbuvir/velpatasvir] as effective treatment options for genotypes 2 and 3, with some nuances,” the researchers wrote. “Indicators of more advanced disease such as increased FIB-4 and a history of decompensated disease were significant predictors of reduced odds of SVR in patients with HCV genotype 3, strongly advocating for earlier treatment of such patients, prior to the onset of advanced liver disease.” – by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.

Daklinza with Sovaldi and ribavirin produced similar rates of sustained virologic response among patients with hepatitis C genotypes 2 and 3 as those treated with Epclusa, according to a recently published study.

“Genotype 2 accounts for 11% of chronic HCV infections both worldwide and in the United States, while genotype 3 accounts for 18% of HCV infections worldwide and 9% in the United States,” Pamela S. Belperio, PharmD, BCPS, from the Department of Veterans Affairs in California, and colleagues wrote. “In difficult-to-treat populations where less evidence-based guidance may be available, real-world providers may make empiric decisions to extend treatment, add [ribavirin], or both.”

The study comprised 2,939 patients with HCV genotype 2 and 2,824 patients with genotype 3 who received either Daklinza (daclatasvir, Bristol-Myers Squibb) with Sovaldi (sofosbuvir, Gilead Sciences) or Epclusa (sofosbuvir/velpatasvir, Gilead Sciences), each treatment course potentially including ribavirin.

Sustained virologic response results were available for 94.4% of patients with HCV genotype 2 and 93% of those with genotype 3. The rates of discontinuation prior to 12 weeks were similar regardless of genotype or treatment regimen.

In the genotype 2 group, SVR rates were similar between daclatasvir/sofosbuvir and sofosbuvir/velpatasvir regardless of treatment with (88.1% vs. 89.5%) or without ribavirin (94.5% vs. 94.4%). Multivariate analysis showed that patients younger than 55 years had decreased odds for SVR (OR = 0.45; 95% CI, 0.27-0.77).

For genotype 3, SVR rates were also similar between those treated with daclatasvir/sofosbuvir and sofosbuvir/velpatasvir regardless of treatment with (88.1% vs. 86.4%) or without ribavirin (90.8% vs. 92%). Multivariate analysis showed that Fibrosis-4 index higher than 3.25 compared with an index between 1.45 and 3.25 (OR = 0.6; 95% CI, 0.43-0.84), decompensated disease (OR = 0.68; 95% CI, 0.47-0.99) and prior HCV treatment (OR = 0.51; 95% CI, 0.36-0.72) predicted decreased odds of SVR.

In the genotype 3 group, the addition of ribavirin to daclatasvir/sofosbuvir and extended treatment from 12 weeks to 24 weeks marginally increased SVR rates among patients with a FIB-4 index higher than 3.25 (90% vs 93.9%).

“Our analysis supports [daclatasvir/sofosbuvir] and [sofosbuvir/velpatasvir] as effective treatment options for genotypes 2 and 3, with some nuances,” the researchers wrote. “Indicators of more advanced disease such as increased FIB-4 and a history of decompensated disease were significant predictors of reduced odds of SVR in patients with HCV genotype 3, strongly advocating for earlier treatment of such patients, prior to the onset of advanced liver disease.” – by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.