Triple therapy underutilized in HCV

Fewer than 20% of patients with hepatitis C virus genotype 1 receive triple therapy with boceprevir or telaprevir, according to Dr. Emerson Y. Chen and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.

The "disappointingly low use of the new therapies, even after a decade without novel medications," suggests that real-world use of these drugs is hampered by factors including safety and the low predicted response rates in prior nonresponders, they wrote.

Dr. Chen of the University of Texas Southwestern Medical School, Dallas, looked at 487 patients with HCV genotype 1 presenting to one of two academic outpatient hepatology practices in Dallas and Miami.

The majority of patients were between 50 and 60 years of age, male, and white. More than two-thirds had private insurance, and half of the patients were treatment naive.

Overall, the authors found that 91 patients (18.7%) were started on triple therapy (boceprevir or telaprevir plus pegylated interferon and ribavirin) while the remaining 396 patients remained untreated.

Dr. Chen then assessed the reasons for treatment deferral. The most common, he found, was contraindication (50.5%), including complications of liver disease and medical comorbidities. The next biggest reason cited for treatment deferral was "patient choice" (22.5%), which included concerns about side effects, limited success rates, financial issues, or inability to commit time for treatment. Finally, the presence of less advanced liver disease (17.4%) and the anticipation (among providers and patients alike) of better future therapies (9.6%) were also factors in triple therapy refusal.

"Although several expert panels for treatment recommendations are available, there exists an uncertainty among providers regarding selecting patients without major contraindications for triple therapy now over newer direct-acting antiviral therapy later," they added.

Next, the researchers compared the triple therapy patients with therapy deferrals.

In univariate analysis, they found that about three-fourths of patients who chose to initiate triple therapy had fibrosis stage 3 or were cirrhotic, although less than 10% had a history of overt decompensation.

"In contrast, among those who deferred treatment, more than 20% had decompensated liver disease, and 46% had early [an] fibrosis stage," they wrote.

Looking at patients’ mean Model for End-Stage Liver Disease scores, cirrhotic patients who deferred treatment registered a 9.3, compared with 7.3 for patients who elected to undergo triple therapy treatment (P less than .001). Additionally, 90% of cirrhotic patients on treatment were Child-Pugh class A compared with 63% in the nontreatment group (P = .003).

Commenting on the findings, Dr. Chen wrote that "although patients with mild fibrosis or persistently normal liver function tests have often not been recommended for repeat biopsy or treatment, they would likely benefit from treatment before they become older or develop contraindications.

"Nevertheless, many hepatologists appear to be recommending deferral of treatment for patients with mild to moderate fibrosis, waiting for the second-generation direct-acting antivirals with even higher sustained virologic response rates" and fewer side effects.

"Newly diagnosed treatment-naive patients along with those with less advanced liver disease will benefit from society-wide consensus regarding therapy initiation now or at a later time."

The authors disclosed funding from the Doris Duke Charitable Foundation and the University of Miami. Two authors disclosed ties to Merck, maker of boceprevir and ribavirin, and Vertex, which makes telaprevir.

Fewer than 20% of patients with hepatitis C virus genotype 1 receive triple therapy with boceprevir or telaprevir, according to Dr. Emerson Y. Chen and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.

The "disappointingly low use of the new therapies, even after a decade without novel medications," suggests that real-world use of these drugs is hampered by factors including safety and the low predicted response rates in prior nonresponders, they wrote.

Dr. Chen of the University of Texas Southwestern Medical School, Dallas, looked at 487 patients with HCV genotype 1 presenting to one of two academic outpatient hepatology practices in Dallas and Miami.

The majority of patients were between 50 and 60 years of age, male, and white. More than two-thirds had private insurance, and half of the patients were treatment naive.

Overall, the authors found that 91 patients (18.7%) were started on triple therapy (boceprevir or telaprevir plus pegylated interferon and ribavirin) while the remaining 396 patients remained untreated.

Dr. Chen then assessed the reasons for treatment deferral. The most common, he found, was contraindication (50.5%), including complications of liver disease and medical comorbidities. The next biggest reason cited for treatment deferral was "patient choice" (22.5%), which included concerns about side effects, limited success rates, financial issues, or inability to commit time for treatment. Finally, the presence of less advanced liver disease (17.4%) and the anticipation (among providers and patients alike) of better future therapies (9.6%) were also factors in triple therapy refusal.

"Although several expert panels for treatment recommendations are available, there exists an uncertainty among providers regarding selecting patients without major contraindications for triple therapy now over newer direct-acting antiviral therapy later," they added.

Next, the researchers compared the triple therapy patients with therapy deferrals.

In univariate analysis, they found that about three-fourths of patients who chose to initiate triple therapy had fibrosis stage 3 or were cirrhotic, although less than 10% had a history of overt decompensation.

"In contrast, among those who deferred treatment, more than 20% had decompensated liver disease, and 46% had early [an] fibrosis stage," they wrote.

Looking at patients’ mean Model for End-Stage Liver Disease scores, cirrhotic patients who deferred treatment registered a 9.3, compared with 7.3 for patients who elected to undergo triple therapy treatment (P less than .001). Additionally, 90% of cirrhotic patients on treatment were Child-Pugh class A compared with 63% in the nontreatment group (P = .003).

Commenting on the findings, Dr. Chen wrote that "although patients with mild fibrosis or persistently normal liver function tests have often not been recommended for repeat biopsy or treatment, they would likely benefit from treatment before they become older or develop contraindications.

"Nevertheless, many hepatologists appear to be recommending deferral of treatment for patients with mild to moderate fibrosis, waiting for the second-generation direct-acting antivirals with even higher sustained virologic response rates" and fewer side effects.

"Newly diagnosed treatment-naive patients along with those with less advanced liver disease will benefit from society-wide consensus regarding therapy initiation now or at a later time."

The authors disclosed funding from the Doris Duke Charitable Foundation and the University of Miami. Two authors disclosed ties to Merck, maker of boceprevir and ribavirin, and Vertex, which makes telaprevir.

Fewer than 20% of patients with hepatitis C virus genotype 1 receive triple therapy with boceprevir or telaprevir, according to Dr. Emerson Y. Chen and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.

The "disappointingly low use of the new therapies, even after a decade without novel medications," suggests that real-world use of these drugs is hampered by factors including safety and the low predicted response rates in prior nonresponders, they wrote.

Dr. Chen of the University of Texas Southwestern Medical School, Dallas, looked at 487 patients with HCV genotype 1 presenting to one of two academic outpatient hepatology practices in Dallas and Miami.

The majority of patients were between 50 and 60 years of age, male, and white. More than two-thirds had private insurance, and half of the patients were treatment naive.

Overall, the authors found that 91 patients (18.7%) were started on triple therapy (boceprevir or telaprevir plus pegylated interferon and ribavirin) while the remaining 396 patients remained untreated.

Dr. Chen then assessed the reasons for treatment deferral. The most common, he found, was contraindication (50.5%), including complications of liver disease and medical comorbidities. The next biggest reason cited for treatment deferral was "patient choice" (22.5%), which included concerns about side effects, limited success rates, financial issues, or inability to commit time for treatment. Finally, the presence of less advanced liver disease (17.4%) and the anticipation (among providers and patients alike) of better future therapies (9.6%) were also factors in triple therapy refusal.

"Although several expert panels for treatment recommendations are available, there exists an uncertainty among providers regarding selecting patients without major contraindications for triple therapy now over newer direct-acting antiviral therapy later," they added.

Next, the researchers compared the triple therapy patients with therapy deferrals.

In univariate analysis, they found that about three-fourths of patients who chose to initiate triple therapy had fibrosis stage 3 or were cirrhotic, although less than 10% had a history of overt decompensation.

"In contrast, among those who deferred treatment, more than 20% had decompensated liver disease, and 46% had early [an] fibrosis stage," they wrote.

Looking at patients’ mean Model for End-Stage Liver Disease scores, cirrhotic patients who deferred treatment registered a 9.3, compared with 7.3 for patients who elected to undergo triple therapy treatment (P less than .001). Additionally, 90% of cirrhotic patients on treatment were Child-Pugh class A compared with 63% in the nontreatment group (P = .003).

Commenting on the findings, Dr. Chen wrote that "although patients with mild fibrosis or persistently normal liver function tests have often not been recommended for repeat biopsy or treatment, they would likely benefit from treatment before they become older or develop contraindications.

"Nevertheless, many hepatologists appear to be recommending deferral of treatment for patients with mild to moderate fibrosis, waiting for the second-generation direct-acting antivirals with even higher sustained virologic response rates" and fewer side effects.

"Newly diagnosed treatment-naive patients along with those with less advanced liver disease will benefit from society-wide consensus regarding therapy initiation now or at a later time."

The authors disclosed funding from the Doris Duke Charitable Foundation and the University of Miami. Two authors disclosed ties to Merck, maker of boceprevir and ribavirin, and Vertex, which makes telaprevir.