Meeting News

DAA therapy effective in patients with HCV and advanced cirrhosis

PARIS — Direct-acting antiviral therapy effectively treated hepatitis C virus in patients with high MELD scores, producing a high rate of sustained virologic response, according to a presentation at the International Liver Congress 2018.

“Real-life SVR rates with DAAs in patients with advanced liver disease ranged from 85% to 100% and were comparable to clinical trial experience. Ribavirin did not influence SVR in this cohort,” Elizabeth C. Verna, MD, of Columbia University, said in her presentation. “Over the year following treatment, stabilization or marginal improvement is seen in those with low MELDs while greater degree of improvement may occur in patients with MELD greater than 16.”

Verna and colleagues used the HCV-TARGET database of patients to cull patients with cirrhosis and MELD higher than 10. Patients initiated DAA therapy between March 2014 and June 2017. Patients with prior liver transplant were excluded. The researchers enrolled 488 patients in the safety cohort and 412 patients in the efficacy cohort; of those, 373 achieved SVR12 and 39 failed treatment. Patients received a variety of approved regimens.

Stratified by MELD score, Verna reported that patients with MELD between 10 and 15 achieved an approximate SVR rate of 90%, between 16 and 21 without ribavirin achieve 90% SVR, and with ribavirin achieved 100%. All patients with MELD greater than 21 achieved SVR. Presence of ascites, history of hepatocellular carcinoma and an albumin of less than 3.5 predicted treatment failure when adjusted for age and gender.

Serious adverse events occurred in 20% of patients overall, either on treatment or within 30 days of treatment ending, she said. Fifteen patients died during treatment or in the SVR12 follow-up period. Eleven patients underwent transplantation while on treatment or just after treatment end.

Verna and colleagues followed 229 participants who had available MELD scores for 9 to 26 weeks after end of treatment and followed 83 participants with available MELD scores after 36 weeks. In the short-term, 22% of those with MELD between 10 and 15 achieved a 3-point or higher decrease in MELD. In the MELD group with baseline score of 16 or higher, 40% achieved a significant decrease in MELD score.

“However, for the cohort overall as an aggregate, the mean change in MELD was about a 1-point decrease,” Verna said. “The average MELD improvement with SVR in the short-term and long-term follow up were similar at 0.9 and 1.0 MELD points, respectively.”

Female sex, genotype 1a, a MELD greater than 16 and a total bilirubin greater than 1.2 at the start of therapy significantly predicted a MELD drop of more than 3 points when adjusted, she added.

“MELD improvement by 3 points or greater was seen in 26% of patients. Predictors of response were female gender, HCV genotype 1a, high baseline MELD score and high baseline total bilirubin,” Verna said. “However, despite achieving SVR, patients with advanced liver disease may still be at considerable risk of decompensation and HCC. Studies evaluating long-term transplant free survival are needed to better understand the benefits of treatment among patients with advanced liver disease.” – Katrina Altersitz

For more information:

Verna E, et al. PS-033. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.

Disclosure: The authors report no relevant financial disclosures.

PARIS — Direct-acting antiviral therapy effectively treated hepatitis C virus in patients with high MELD scores, producing a high rate of sustained virologic response, according to a presentation at the International Liver Congress 2018.

“Real-life SVR rates with DAAs in patients with advanced liver disease ranged from 85% to 100% and were comparable to clinical trial experience. Ribavirin did not influence SVR in this cohort,” Elizabeth C. Verna, MD, of Columbia University, said in her presentation. “Over the year following treatment, stabilization or marginal improvement is seen in those with low MELDs while greater degree of improvement may occur in patients with MELD greater than 16.”

Verna and colleagues used the HCV-TARGET database of patients to cull patients with cirrhosis and MELD higher than 10. Patients initiated DAA therapy between March 2014 and June 2017. Patients with prior liver transplant were excluded. The researchers enrolled 488 patients in the safety cohort and 412 patients in the efficacy cohort; of those, 373 achieved SVR12 and 39 failed treatment. Patients received a variety of approved regimens.

Stratified by MELD score, Verna reported that patients with MELD between 10 and 15 achieved an approximate SVR rate of 90%, between 16 and 21 without ribavirin achieve 90% SVR, and with ribavirin achieved 100%. All patients with MELD greater than 21 achieved SVR. Presence of ascites, history of hepatocellular carcinoma and an albumin of less than 3.5 predicted treatment failure when adjusted for age and gender.

Serious adverse events occurred in 20% of patients overall, either on treatment or within 30 days of treatment ending, she said. Fifteen patients died during treatment or in the SVR12 follow-up period. Eleven patients underwent transplantation while on treatment or just after treatment end.

Verna and colleagues followed 229 participants who had available MELD scores for 9 to 26 weeks after end of treatment and followed 83 participants with available MELD scores after 36 weeks. In the short-term, 22% of those with MELD between 10 and 15 achieved a 3-point or higher decrease in MELD. In the MELD group with baseline score of 16 or higher, 40% achieved a significant decrease in MELD score.

“However, for the cohort overall as an aggregate, the mean change in MELD was about a 1-point decrease,” Verna said. “The average MELD improvement with SVR in the short-term and long-term follow up were similar at 0.9 and 1.0 MELD points, respectively.”

Female sex, genotype 1a, a MELD greater than 16 and a total bilirubin greater than 1.2 at the start of therapy significantly predicted a MELD drop of more than 3 points when adjusted, she added.

“MELD improvement by 3 points or greater was seen in 26% of patients. Predictors of response were female gender, HCV genotype 1a, high baseline MELD score and high baseline total bilirubin,” Verna said. “However, despite achieving SVR, patients with advanced liver disease may still be at considerable risk of decompensation and HCC. Studies evaluating long-term transplant free survival are needed to better understand the benefits of treatment among patients with advanced liver disease.” – Katrina Altersitz

For more information:

Verna E, et al. PS-033. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.

Disclosure: The authors report no relevant financial disclosures.

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