In the Journals

Novel score predicts DAA benefit in patients with HCV, decompensated cirrhosis

Researchers have developed a predictive score that quantifies the potential benefits of direct-acting antiviral therapy for patients with hepatitis C and decompensated cirrhosis, according to recently published data.

Michael P. Curry, MD
Michael P. Curry

Five factors – BMI, hepatic encephalopathy, ascites, serum albumin and alanine aminotransferase levels – contribute to the novel BE3A score.

“There are certain hepatitis C medications that you cannot use in patients with decompensation because they are predominantly cleared by the liver; they’re hepatically metabolized and have been associated with the worsening of decompensated cirrhosis,” Michael P. Curry, MD, from the Beth Israel Deaconess Medical Center, Boston, told Healio Gastroenterology and Liver Disease. “Getting rid of the virus in a patient with liver failure is only one component of treating their disease. Getting rid of the virus doesn’t necessarily mean that that patient’s liver failure is going to improve.”

Curry and colleagues sought to determine the rate at which Child-Pugh Turcotte grades B or C reduced to grade A and the factors involved. They conducted an integrated analysis of data from the SOLAR-1, SOLAR-2, ASTRAL-4 and GS-US-334-0125 clinical trials of sofosbuvir-based DAA therapy in adult patients with advanced liver disease.

All patients had chronic HCV and had either Child-Pugh Turcotte (CPT) class B (n = 502) or class C (n = 120). Most patients had ascites (77%) and mild encephalopathy (59%) at baseline. Overall sustained virologic response was 85%. During follow-up, 17 patients underwent liver transplantation and 35 patients died.

Of the 528 patients who achieved SVR and had 36 weeks of follow-up data, 31.6% with baseline CPT class B and 12.3% of patients with class C achieved a reduction to class A.

“We identified that over 30% of individuals were able to not only get rid of the virus ... but also had an improvement in liver function. They improved to the point that they no longer had liver failure,” Curry said.

The researchers found that an increased BMI, the presence of encephalopathy or ascites, and albumin less than 3.5 g/dL correlated with a lower rate of CPT reduction.

Investigators calculated the BE3A score by the sum of BMI less than 25 kg/m2, absence of encephalopathy, absence of ascites, ALT higher than 60 IU/L, and albumin higher than 3.5 g/dL. Each factor was counted as 1 point and each point increase correlated with a progressive increase in the likelihood of reduction to CPT class A with DAA therapy.

The researchers found that a BE3A score of 4 or 5 correlated with a 75% chance of achieving CPT class A, whereas patients with a score of 1 had a 25% chance and those with a score of 0 had a less than 5% chance. BE3A scores 1 through 5 showed no significant difference in predicting liver transplantation or death, but a score of 0 correlated with a 25% chance of mortality or need for liver transplantation.

The score demonstrated a high range of accuracy and specificity.

“The importance of this score is, if you’re sitting in front of a patient and you’re determining whether you should put the patient on the transplant list or get them hepatitis C treatment, you can take their baseline characteristics, plug them into the calculator and you can give them a sense of what is their likelihood that their liver function will improve,” Curry said.

“If they have a high likelihood that they’ll improve, it makes sense to start them on antiviral therapy because it may improve their liver function to the point that they don’t need a liver transplant,” Curry concluded. “However, if it’s a low likelihood, you may choose to put that patient on the liver transplant list, get them a liver, and then treat their hepatitis C afterwards.” – by Talitha Bennett

Disclosure: Curry reports he received research or grant support from Gilead Sciences and fees for advising from AbbVie, Bristol-Myers Squibb and Gilead Sciences. Please see the full study for the other authors’ relevant financial disclosures.

Researchers have developed a predictive score that quantifies the potential benefits of direct-acting antiviral therapy for patients with hepatitis C and decompensated cirrhosis, according to recently published data.

Michael P. Curry, MD
Michael P. Curry

Five factors – BMI, hepatic encephalopathy, ascites, serum albumin and alanine aminotransferase levels – contribute to the novel BE3A score.

“There are certain hepatitis C medications that you cannot use in patients with decompensation because they are predominantly cleared by the liver; they’re hepatically metabolized and have been associated with the worsening of decompensated cirrhosis,” Michael P. Curry, MD, from the Beth Israel Deaconess Medical Center, Boston, told Healio Gastroenterology and Liver Disease. “Getting rid of the virus in a patient with liver failure is only one component of treating their disease. Getting rid of the virus doesn’t necessarily mean that that patient’s liver failure is going to improve.”

Curry and colleagues sought to determine the rate at which Child-Pugh Turcotte grades B or C reduced to grade A and the factors involved. They conducted an integrated analysis of data from the SOLAR-1, SOLAR-2, ASTRAL-4 and GS-US-334-0125 clinical trials of sofosbuvir-based DAA therapy in adult patients with advanced liver disease.

All patients had chronic HCV and had either Child-Pugh Turcotte (CPT) class B (n = 502) or class C (n = 120). Most patients had ascites (77%) and mild encephalopathy (59%) at baseline. Overall sustained virologic response was 85%. During follow-up, 17 patients underwent liver transplantation and 35 patients died.

Of the 528 patients who achieved SVR and had 36 weeks of follow-up data, 31.6% with baseline CPT class B and 12.3% of patients with class C achieved a reduction to class A.

“We identified that over 30% of individuals were able to not only get rid of the virus ... but also had an improvement in liver function. They improved to the point that they no longer had liver failure,” Curry said.

The researchers found that an increased BMI, the presence of encephalopathy or ascites, and albumin less than 3.5 g/dL correlated with a lower rate of CPT reduction.

Investigators calculated the BE3A score by the sum of BMI less than 25 kg/m2, absence of encephalopathy, absence of ascites, ALT higher than 60 IU/L, and albumin higher than 3.5 g/dL. Each factor was counted as 1 point and each point increase correlated with a progressive increase in the likelihood of reduction to CPT class A with DAA therapy.

The researchers found that a BE3A score of 4 or 5 correlated with a 75% chance of achieving CPT class A, whereas patients with a score of 1 had a 25% chance and those with a score of 0 had a less than 5% chance. BE3A scores 1 through 5 showed no significant difference in predicting liver transplantation or death, but a score of 0 correlated with a 25% chance of mortality or need for liver transplantation.

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The score demonstrated a high range of accuracy and specificity.

“The importance of this score is, if you’re sitting in front of a patient and you’re determining whether you should put the patient on the transplant list or get them hepatitis C treatment, you can take their baseline characteristics, plug them into the calculator and you can give them a sense of what is their likelihood that their liver function will improve,” Curry said.

“If they have a high likelihood that they’ll improve, it makes sense to start them on antiviral therapy because it may improve their liver function to the point that they don’t need a liver transplant,” Curry concluded. “However, if it’s a low likelihood, you may choose to put that patient on the liver transplant list, get them a liver, and then treat their hepatitis C afterwards.” – by Talitha Bennett

Disclosure: Curry reports he received research or grant support from Gilead Sciences and fees for advising from AbbVie, Bristol-Myers Squibb and Gilead Sciences. Please see the full study for the other authors’ relevant financial disclosures.