In the Journals

Daclatasvir/Asunaprevir Safe, Effective in HCV, Renal Dysfunction

A combination regimen of daclatasvir and asunaprevir was comparably safe and effective for treating patients with hepatitis C virus infection and renal dysfunction compared with those without renal dysfunction, according to recent Japanese study data.

“Treatment with the combination of [daclatasvir/asunaprevir; Bristol-Myers Squibb] has at least the same effectiveness and safety in patients with renal dysfunction as in those without renal dysfunction [and] fewer patients with renal dysfunction developed liver injury,” researchers wrote.

To evaluate the safety and efficacy of this combination regimen in patients infected with HCV genotype 1b who also had renal dysfunction, investigators performed a multicenter study of patients being treated in clinical practice at Nagoya University Hospital and 50 affiliate sites. They recruited 924 patients and evaluated 897 with baseline renal function data, 110 of whom had an estimated glomerular filtration rate less than 50 mL/min, and 43 of whom had an eGFR of less than 30 mL/min.

Overall, 89.3% of patients with an eGFR greater than 50 mL/min achieved SVR12, 93% of patients with an eGFR between 30 and 49 mL/min achieved SVR12, and 97% of patients with an eGFR less than 30 mL/min achieved SVR12; these results were all statistically comparable.

Moreover, 88.2% of patients with an eGFR less than 30 mL/min had early viral response at 2 weeks after treatment was initiated, which was significantly higher compared with patients with an eGFR greater than 30 mL/min (59.7%; P = .001).

Discontinuation rates were also similar between patients with and without renal function, with 8.5% of patients with an eGFR greater than 50 mL/min discontinuing treatment compared with 11.9% of patients with an eGFR between 30 and 49 mL/min and 4.7% of patients with an eGFR less than 30 mL/min.

Notably, grade 3 or higher liver injury occurred in 6.1% of patients with an eGFR greater than 50 mL/min compared with 3% of patients with an eGFR between 30 and 49 mL/min and none of the patients with an eGFR less than 30 mL/min.

Finally, liver injury occurred in 1.8% of patients with an eGFR less than 50 mL/min compared with 6.1% of patients with an eGFR greater than 50 mL/min (P < .001).

“Our results confirmed [previous] findings and we also showed that SVR was similar in all patients regardless of the severity of renal dysfunction,” the investigators concluded. – by Adam Leitenberger

Disclosures: One researcher reports he has received research support from AbbVie GK, Bayer Yakuhin Ltd., Taiho Pharmaceutical CO. LTD., Astellas Pharma Inc., Kyowa Hakko Kirin Co. Ltd., Takeda Pharmaceutical Company Limited., Otsuka Pharmaceutical Co. Ltd., AstraZeneca K.K., Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Company Limited, Eisai Co. Ltd., Merck & Co. Inc., Sumitomo Dainippon Pharma Co. Ltd., and Bristol-Myers Squibb.

A combination regimen of daclatasvir and asunaprevir was comparably safe and effective for treating patients with hepatitis C virus infection and renal dysfunction compared with those without renal dysfunction, according to recent Japanese study data.

“Treatment with the combination of [daclatasvir/asunaprevir; Bristol-Myers Squibb] has at least the same effectiveness and safety in patients with renal dysfunction as in those without renal dysfunction [and] fewer patients with renal dysfunction developed liver injury,” researchers wrote.

To evaluate the safety and efficacy of this combination regimen in patients infected with HCV genotype 1b who also had renal dysfunction, investigators performed a multicenter study of patients being treated in clinical practice at Nagoya University Hospital and 50 affiliate sites. They recruited 924 patients and evaluated 897 with baseline renal function data, 110 of whom had an estimated glomerular filtration rate less than 50 mL/min, and 43 of whom had an eGFR of less than 30 mL/min.

Overall, 89.3% of patients with an eGFR greater than 50 mL/min achieved SVR12, 93% of patients with an eGFR between 30 and 49 mL/min achieved SVR12, and 97% of patients with an eGFR less than 30 mL/min achieved SVR12; these results were all statistically comparable.

Moreover, 88.2% of patients with an eGFR less than 30 mL/min had early viral response at 2 weeks after treatment was initiated, which was significantly higher compared with patients with an eGFR greater than 30 mL/min (59.7%; P = .001).

Discontinuation rates were also similar between patients with and without renal function, with 8.5% of patients with an eGFR greater than 50 mL/min discontinuing treatment compared with 11.9% of patients with an eGFR between 30 and 49 mL/min and 4.7% of patients with an eGFR less than 30 mL/min.

Notably, grade 3 or higher liver injury occurred in 6.1% of patients with an eGFR greater than 50 mL/min compared with 3% of patients with an eGFR between 30 and 49 mL/min and none of the patients with an eGFR less than 30 mL/min.

Finally, liver injury occurred in 1.8% of patients with an eGFR less than 50 mL/min compared with 6.1% of patients with an eGFR greater than 50 mL/min (P < .001).

“Our results confirmed [previous] findings and we also showed that SVR was similar in all patients regardless of the severity of renal dysfunction,” the investigators concluded. – by Adam Leitenberger

Disclosures: One researcher reports he has received research support from AbbVie GK, Bayer Yakuhin Ltd., Taiho Pharmaceutical CO. LTD., Astellas Pharma Inc., Kyowa Hakko Kirin Co. Ltd., Takeda Pharmaceutical Company Limited., Otsuka Pharmaceutical Co. Ltd., AstraZeneca K.K., Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Company Limited, Eisai Co. Ltd., Merck & Co. Inc., Sumitomo Dainippon Pharma Co. Ltd., and Bristol-Myers Squibb.