TURQUOISE-II: Demographics, viral factors did not predict SVR after 3D regimen

Issue: December 2014

BOSTON — Sustained virologic response rates after treatment with an all-oral regimen of coformulated ABT-450 boosted with ritonavir, ombitasvir and dasabuvir plus ribavirin were high in patients with hepatitis C virus genotype 1 infection and cirrhosis across a broad range of subgroups and regardless of baseline characteristics.

Michael W. Fried, MD, professor of medicine and director of the University of North Carolina Liver Center, presented new data from the TURQUOISE-II study at The Liver Meeting.

Fried said the study aim was to determine the extent to which baseline demographic, viral and disease characteristics impact outcomes in patients with compensated cirrhosis.

“Efficacy data among cirrhotics are limited to small patient subgroups,” he said.

Eligible participants were HCV treatment naive or experienced, aged younger than 70 years, had a BMI less than 38, had documented cirrhosis and were classified as Child-Pugh-Turcotte class A. In total, 208 patients received 12 weeks of treatment with the 3D regimen (AbbVie) plus ribavirin and 172 patients received 24 weeks of treatment.

“This was an analysis of predictors of interest. We looked at HCV RNA level and subtype and host factors such as age, sex, BMI and history of disease,” Fried said.

Overall SVR at 12 weeks after the completion of therapy was 91.8% for patients who received 12 weeks of treatment and 96.5% for patients who received 24 weeks of treatment.

“[In] all subgroups [studied], the 95% confidence interval overlapped across all characteristics,” Fried said.

When examined by HCV genotype, the SVR12 rate was 91.6% for patients with genotype 1a and 99% for patients with genotype 1b.

SVR12 rates for patients aged younger than 65 years ranged from 91.2% to 100% for 12 and 24 weeks of therapy, according to Fried. Similarly, gender did not significantly impact SVR.

The 12-week regimen was associated with an SVR12 rate of 86% for patients with diabetes and 86.8% for injection drug users.

In addition, “the presence of depression or bipolar disorder did not impact SVR12 rates,” Fried said. He added that CC or CT genotypes were associated with similar SVR12 rates regardless of duration of treatment; however, patients with the TT genotype treated for 12 weeks had an SVR12 rate of 80.5%, while those with the TT genotype treated for 24 weeks had a rate of 94%.

Patients with genotype 1a treated for 12 weeks had 89% SVR12, compared with 95% for those treated for 24 weeks. For patients with genotype 1b disease, SVR12 rates were higher than 96% for 12 or 24 weeks of treatment.

While previous null responders treated for 24 weeks reached 94% SVR12, those treated for 12 weeks reached 87% SVR12.

Patients with low serum albumin (<35 g/L) had SVR12 rates between 84% and 89% for 12 or 24 weeks of treatment, while those with low platelet counts (<1,000x10⁹/L) treated for 12 weeks also demonstrated slightly lower response.

“Overall, there were 23 patients who did not achieve SVR12,” Fried said. “This included 17 patients in the 12-week arm and six patients in the 24-week arm. There were 12 relapses in the 12-week arm and one relapse in the 24-week arm.”

“The predictive factors for failure to reach SVR12 included IL28B TT, prior null response and HCV genotype 1a,” he added. “Importantly, demographics, viral factors and disease related factors did not have a substantial impact.” – by Rob Volansky

For more information:

Fried MW. Abstract 81. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.

Disclosure: Fried reports consulting for and receiving grant/research support for AbbVie.