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SOLAR 2: Harvoni yields high SVR12 in decompensated patients
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VIENNA — Twelve or 24 weeks of Harvoni with ribavirin demonstrated 12-week sustained virologic response rates of 85 to 88% in decompensated patients, according to findings presented at the 2015 International Liver Congress.
Michael Manns, MD, of Hannover Medical School in Hannover, Germany, and colleagues treated 328 patients with genotype 1 or 4 disease. The analysis included 168 post-transplant patients without cirrhosis (fibrosis stage F0-F3) or with compensated cirrhosis (Child-Pugh-Turcotte [CPT] A) treated for 12 weeks (n = 86) or 24 weeks (n = 82). There were also 160 pre- and post-transplantation patients with decompensated cirrhosis (CPT B/C) treated for 12 weeks (n = 78) or 24 weeks (n = 82). All groups were treated with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) plus ribavirin.
Michael Manns
SVR12 rates in post-transplant non-cirrhotic or compensated cirrhotics were 95% for 12 weeks of therapy and 98% for 24 weeks of therapy. Among patients with more severe disease, SVR12 rates were 85% for 12 weeks of therapy and 88% for 24 weeks of therapy.
“Twelve or 24 weeks does not seem to differ significantly,” Manns said.
For genotype 1 patients, SVR12 rates in the non-cirrhotic or compensated arm were 96% after 12 weeks of treatment and 98% after 24 weeks of therapy. SVR12 rates for genotype 1 patients in the more severe group were 88% after 12 weeks of treatment and 89% after 24 weeks of treatment.
In a small number of genotype 4 patients, the less severe patients treated for 12 weeks reached a 91% SVR12 rate (10/11 patients) compared with 100% (7/7) for those treated for 24 weeks. Among patients with more severe genotype 4 disease, 57% (4/7) reached SVR12 after 12 weeks of treatment and 86% (6/7) reached SVR12 after 24 weeks of treatment.
“The number of patients was too low to allow final conclusions for genotype 4,” Manns said.
He added that approximately one-third of patients with CPT B improved to CPT A, while one-half of those with CPT C improved to CPT B.
Serious adverse events were reported in 14% of patients with compensated cirrhosis and 24% of patients with decompensated disease.
“There were some deaths in this cohort of patients, but none of the deaths were considered to be treatment related,” Manns said.
“In summary, ledipasvir and sofosbuvir plus ribavirin resulted in high SVR12 rates in patients with decompensated liver disease or who were post-transplantation,” he concluded, pointing to this as a breakthrough for post-transplant decompensated patients due to their contraindication with interferon. “These patients were not eligible for treatment in the past and can now be treated.” - by Rob Volansky
For more information:
Manns M, et al. Abstract G02. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Manns reports receiving grants from Abbvie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck, Novartis and Roche; and being a consultant for Abbvie, Boehringer Ingelheim, Bristol-Myers Squibb, Idenix, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis and Roche.
Editor’s note: This item has been updated with clarifications from the presenter.