Daklinza/asunaprevir yields high SVR in Asians with HCV genotype 1b

Phase 3 clinical trial data presented at the Asian Pacific Association for the Study of the Liver Conference showed that a combination regimen of Daklinza and asunaprevir was safe and effective among Asian patients with hepatitis C genotype 1b virus infection, according to a press release from Bristol-Myers Squibb.

“These results signal that the daclatasvir and asunaprevir regimen could provide a highly effective all-oral, interferon- and ribavirin-free treatment for many Chinese HCV patients with genotype 1b infection,” Lai Wei, MD, director of the Peking University Hepatology Institute and chief of the department of hepatology at Peking University People’s Hospital, Beijing, China, said in the release. “This is an important finding because the burden of HCV in China is extremely high, and newer direct-acting antivirals have yet to be introduced for any patients.”

Lai Wei

In the study, 159 patients received 60 mg of Daklinza (daclatasvir, Bristol-Myers Squibb) once daily plus 100 mg of asunaprevir (Bristol-Myers Squibb) twice daily for 24 weeks. Overall, 91% achieved SVR24, which increased to 98%, among patients without NS5A resistance-associated variants at baseline, according to the release.

The patients treated were from mainland China (80%), Korea (11%) and Taiwan (9%), and included some with cirrhosis (33%) and IL28B nonCC genotypes (40%). The release stated the SVR24 results were similar across all subgroups, including those with cirrhosis (90%), patients from Korea (94%) and patients from Taiwan (87%).

Serious adverse events (n = 5), grade 4 laboratory abnormalities (n = 3) and deaths (n =1) reported during the trial were unrelated to the drugs. The most common AEs were decrease in platelets (9%), upper respiratory tract infection (8%), ALT increase (7%), ANC decrease (7%), monocyte decrease (6%), white blood cell decrease (6%), thrombocytopenia (6%) and pruritus (6%), according to the release. Two patients discontinued treatment due to AEs.

“So much progress has been made globally in the fight against chronic hepatitis C, but the battle against the disease is not over,” Douglas Manion, MD, head of specialty development at Bristol-Myers Squibb, said in the release.

Clinical data presented at The Liver Meeting 2015 revealed the drug regimen yielded high SVR rates among Asian patients at 12 weeks (91%).

Disclosure: Manion is employed by Bristol-Myers Squibb. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Wei at the time of publication.