Meeting News Coverage

BOSON: Sovaldi plus PEG-RBV improved SVR12 in genotype 3 HCV

VIENNA — Twelve weeks of therapy with Sovaldi plus peginterferon and ribavirin was associated with 12-week sustained virologic response rates higher than 90% in patients with genotype 3 disease, according to data presented at the 2015 International Liver Congress.

“We took the toughest of the tough,” Graham R. Foster, MD, professor of hepatology at Queen Marys University of London, said during the Late Breakers session. “It seems that interferon may still have a role to play in these particular populations.”

Foster presented findings for a cohort of 592 patients that included genotype 2 patients with cirrhosis who previously failed treatment and genotype 3 with cirrhosis and previous peginterferon-ribavirin failure. Overall, 53% were treatment-experienced and 37% had cirrhosis.

The three-arm study included 196 patients treated with 400 mg Sovaldi (sofosbuvir, Gilead)  and 1,000 to 1,200 mg ribavirin daily for 16 weeks, 199 patients treated with sofosbuvir and ribavirin for 24 weeks and 197 patients treated with sofosbuvir, peginterferon and ribavirin for 12 weeks.

In the genotype 3 cohort, Foster said the 12-week regimen “scooped the pool” with a 93% SVR12 rate, compared with 84% (P = .008) for the 24-week regimen and 71% (P < .001) for the 16-week regimen.

Further analysis of patients in the 12-week arm indicated SVR12 rates ranging from 86% in patients with cirrhosis who were treatment-experienced to 96% in those without cirrhosis who were treatment-naive. Most of the interferon treatment subgroups achieved SVR12 higher than 90%.

The range was broader in the other treatment subgroups, with treatment experienced cirrhotics in the 16-week arm responding at 47% SVR12.

An analysis of patients with genotype 2 also was included. Responses ranged from 87% in the 16-week treatment arm, 100% in the 24-week arm and 94% in the 12-week arm.

Foster showed that the interferon regimen was “surprisingly well tolerated.”

Fatigue, headache, insomnia and nausea were reported, but only 1% of the cohort discontinued as a result of adverse events.

“These are interesting new data,” Foster said. “These are a group of patients who can’t wait for the next generation of drugs to mature, … but I don’t think any of us are pretending this is the perfect long-term solution.” – by Rob Volansky and Katrina Altersitz

For More Information:

Foster GR. Abstract L05. Presented at: International Liver Congress; April 22-26, 2015; Vienna.

Disclosure: Foster reports being a consultant with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis, Roche; sponsored lectures for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis and Roche. This study was funded by Gilead Sciences.

 

VIENNA — Twelve weeks of therapy with Sovaldi plus peginterferon and ribavirin was associated with 12-week sustained virologic response rates higher than 90% in patients with genotype 3 disease, according to data presented at the 2015 International Liver Congress.

“We took the toughest of the tough,” Graham R. Foster, MD, professor of hepatology at Queen Marys University of London, said during the Late Breakers session. “It seems that interferon may still have a role to play in these particular populations.”

Foster presented findings for a cohort of 592 patients that included genotype 2 patients with cirrhosis who previously failed treatment and genotype 3 with cirrhosis and previous peginterferon-ribavirin failure. Overall, 53% were treatment-experienced and 37% had cirrhosis.

The three-arm study included 196 patients treated with 400 mg Sovaldi (sofosbuvir, Gilead)  and 1,000 to 1,200 mg ribavirin daily for 16 weeks, 199 patients treated with sofosbuvir and ribavirin for 24 weeks and 197 patients treated with sofosbuvir, peginterferon and ribavirin for 12 weeks.

In the genotype 3 cohort, Foster said the 12-week regimen “scooped the pool” with a 93% SVR12 rate, compared with 84% (P = .008) for the 24-week regimen and 71% (P < .001) for the 16-week regimen.

Further analysis of patients in the 12-week arm indicated SVR12 rates ranging from 86% in patients with cirrhosis who were treatment-experienced to 96% in those without cirrhosis who were treatment-naive. Most of the interferon treatment subgroups achieved SVR12 higher than 90%.

The range was broader in the other treatment subgroups, with treatment experienced cirrhotics in the 16-week arm responding at 47% SVR12.

An analysis of patients with genotype 2 also was included. Responses ranged from 87% in the 16-week treatment arm, 100% in the 24-week arm and 94% in the 12-week arm.

Foster showed that the interferon regimen was “surprisingly well tolerated.”

Fatigue, headache, insomnia and nausea were reported, but only 1% of the cohort discontinued as a result of adverse events.

“These are interesting new data,” Foster said. “These are a group of patients who can’t wait for the next generation of drugs to mature, … but I don’t think any of us are pretending this is the perfect long-term solution.” – by Rob Volansky and Katrina Altersitz

For More Information:

Foster GR. Abstract L05. Presented at: International Liver Congress; April 22-26, 2015; Vienna.

Disclosure: Foster reports being a consultant with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis, Roche; sponsored lectures for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis and Roche. This study was funded by Gilead Sciences.

 

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