Boceprevir, telaprevir linked to anemia in HCV-infected seniors

WASHINGTON – Older patients with hepatitis C experienced more adverse events and more serious adverse events while treated with boceprevir or telaprevir, and they discontinued treatment more frequently than did their younger peers, according to data from the HCV-TARGET trial.

Dr. Andrew Aronsohn of the University of Chicago and his colleagues studied a subset of HCV-TARGET that comprised 1,100 patients who started treatment on a direct-acting antiviral agent before April 2012.

Most patients were aged younger than 65 years; 73 were older. Of those, 56 were treated with telaprevir and 17 with boceprevir, Dr. Aronsohn reported at the annual meeting of the American Association for the Study of Liver Diseases.

In the older group, the median age was 67 years; 53% were women. Three-fifths had been treated previously for their hepatitis C infection (HCV).

Seniors were more likely to have diabetes, coronary artery disease, and inferior renal function than were their younger peers, though not significantly so. The rate of cirrhosis in both younger and older patients was roughly the same, at just over 40%.

Treatment response was similar for older and younger patients for both drugs. Sustained virologic response (SVR) to boceprevir in treatment-naive patients was 67% for older patients and 57% for younger patients. For treatment experienced patients, the rates were 36% and 37%, respectively.

SVR to telaprevir in treatment-naive patients was 75% for older patients vs. 60% for younger patients. In treatment-experienced patients, SVR was 53% vs. 59%, respectively.

A greater percentage of older patients discontinued treatment early – 44% vs. 36%.

Nearly all (94%) older patients treated with boceprevir became anemic; 18%, or 3 patients, were classified as having severe anemia, requiring either hospitalization for their anemia or expedited reporting of the adverse event to the Food and Drug Administration. In comparison, 63% of younger patients became anemic, with 6% classified as severe.

In patients treated with telaprevir, 77% of older patients became anemic compared with 65% of younger patients. Anemia was classified as severe in 9% of older patients and 3% of younger ones.

"Seven baseline characteristics were association with anemia," Dr. Aronsohn said. Age was independently associated with developing anemia.

He cautioned that while viral kinetics and treatment outcomes were similar for older and younger patients, adverse events – particularly anemia – and early discontinuation pose a concern in patients aged older than 65 years.

HCV-TARGET is a consortium of more than 100 academic and community medical centers performing a longitudinal, observational study. Treatment is not standardized and is administered per the local standard of care. The investigators seek to capture clinical, adverse event, virological, and demographic data on patients treated for hepatitis C.

Dr. Aronsohn’s conflicts of interest were not available at press time. HCT-TARGET is sponsored by Vertex Pharmaceuticals, Merck, Genentech, and Kadmon Pharmaceuticals.

[email protected]

WASHINGTON – Older patients with hepatitis C experienced more adverse events and more serious adverse events while treated with boceprevir or telaprevir, and they discontinued treatment more frequently than did their younger peers, according to data from the HCV-TARGET trial.

Dr. Andrew Aronsohn of the University of Chicago and his colleagues studied a subset of HCV-TARGET that comprised 1,100 patients who started treatment on a direct-acting antiviral agent before April 2012.

Most patients were aged younger than 65 years; 73 were older. Of those, 56 were treated with telaprevir and 17 with boceprevir, Dr. Aronsohn reported at the annual meeting of the American Association for the Study of Liver Diseases.

In the older group, the median age was 67 years; 53% were women. Three-fifths had been treated previously for their hepatitis C infection (HCV).

Seniors were more likely to have diabetes, coronary artery disease, and inferior renal function than were their younger peers, though not significantly so. The rate of cirrhosis in both younger and older patients was roughly the same, at just over 40%.

Treatment response was similar for older and younger patients for both drugs. Sustained virologic response (SVR) to boceprevir in treatment-naive patients was 67% for older patients and 57% for younger patients. For treatment experienced patients, the rates were 36% and 37%, respectively.

SVR to telaprevir in treatment-naive patients was 75% for older patients vs. 60% for younger patients. In treatment-experienced patients, SVR was 53% vs. 59%, respectively.

A greater percentage of older patients discontinued treatment early – 44% vs. 36%.

Nearly all (94%) older patients treated with boceprevir became anemic; 18%, or 3 patients, were classified as having severe anemia, requiring either hospitalization for their anemia or expedited reporting of the adverse event to the Food and Drug Administration. In comparison, 63% of younger patients became anemic, with 6% classified as severe.

In patients treated with telaprevir, 77% of older patients became anemic compared with 65% of younger patients. Anemia was classified as severe in 9% of older patients and 3% of younger ones.

"Seven baseline characteristics were association with anemia," Dr. Aronsohn said. Age was independently associated with developing anemia.

He cautioned that while viral kinetics and treatment outcomes were similar for older and younger patients, adverse events – particularly anemia – and early discontinuation pose a concern in patients aged older than 65 years.

HCV-TARGET is a consortium of more than 100 academic and community medical centers performing a longitudinal, observational study. Treatment is not standardized and is administered per the local standard of care. The investigators seek to capture clinical, adverse event, virological, and demographic data on patients treated for hepatitis C.

Dr. Aronsohn’s conflicts of interest were not available at press time. HCT-TARGET is sponsored by Vertex Pharmaceuticals, Merck, Genentech, and Kadmon Pharmaceuticals.

[email protected]

WASHINGTON – Older patients with hepatitis C experienced more adverse events and more serious adverse events while treated with boceprevir or telaprevir, and they discontinued treatment more frequently than did their younger peers, according to data from the HCV-TARGET trial.

Dr. Andrew Aronsohn of the University of Chicago and his colleagues studied a subset of HCV-TARGET that comprised 1,100 patients who started treatment on a direct-acting antiviral agent before April 2012.

Most patients were aged younger than 65 years; 73 were older. Of those, 56 were treated with telaprevir and 17 with boceprevir, Dr. Aronsohn reported at the annual meeting of the American Association for the Study of Liver Diseases.

In the older group, the median age was 67 years; 53% were women. Three-fifths had been treated previously for their hepatitis C infection (HCV).

Seniors were more likely to have diabetes, coronary artery disease, and inferior renal function than were their younger peers, though not significantly so. The rate of cirrhosis in both younger and older patients was roughly the same, at just over 40%.

Treatment response was similar for older and younger patients for both drugs. Sustained virologic response (SVR) to boceprevir in treatment-naive patients was 67% for older patients and 57% for younger patients. For treatment experienced patients, the rates were 36% and 37%, respectively.

SVR to telaprevir in treatment-naive patients was 75% for older patients vs. 60% for younger patients. In treatment-experienced patients, SVR was 53% vs. 59%, respectively.

A greater percentage of older patients discontinued treatment early – 44% vs. 36%.

Nearly all (94%) older patients treated with boceprevir became anemic; 18%, or 3 patients, were classified as having severe anemia, requiring either hospitalization for their anemia or expedited reporting of the adverse event to the Food and Drug Administration. In comparison, 63% of younger patients became anemic, with 6% classified as severe.

In patients treated with telaprevir, 77% of older patients became anemic compared with 65% of younger patients. Anemia was classified as severe in 9% of older patients and 3% of younger ones.

"Seven baseline characteristics were association with anemia," Dr. Aronsohn said. Age was independently associated with developing anemia.

He cautioned that while viral kinetics and treatment outcomes were similar for older and younger patients, adverse events – particularly anemia – and early discontinuation pose a concern in patients aged older than 65 years.

HCV-TARGET is a consortium of more than 100 academic and community medical centers performing a longitudinal, observational study. Treatment is not standardized and is administered per the local standard of care. The investigators seek to capture clinical, adverse event, virological, and demographic data on patients treated for hepatitis C.

Dr. Aronsohn’s conflicts of interest were not available at press time. HCT-TARGET is sponsored by Vertex Pharmaceuticals, Merck, Genentech, and Kadmon Pharmaceuticals.

[email protected]