In the Journals

Study confirms relevance of SVR endpoint for patients receiving HCV treatment

Jordan J. Feld, D, MPH, FAASLD
Jordan J. Feld

SVR, which has been challenged in regard to its association with clinical outcomes, has been confirmed as a prognosis-altering endpoint in patients with hepatitis C virus, according to findings published in Clinical Infectious Diseases.

As a result, SVR can serve as a surrogate endpoint that results in better clinical outcomes, according to the study results.

“Despite a lot of data showing the benefits of SVR in terms of both liver and non-liver-related outcomes, some have still argued that SVR is not a clinically important endpoint. They have made the case that, although studies have shown that patients who achieve SVR do better than those who do not, it is possible that SVR itself is part of, rather than the cause of, a good prognosis,” Jordan J. Feld, D, MPH, FAASLD, from the University of Toronto University Health Network, told Healio. “In a sense, they are saying that the people who achieved SVR would have done better than those who did not even if they had never been treated.”

Feld and colleagues gathered data from patients beginning treatment with interferon (IFN) or direct-acting antivirals between June 2006 and December 2016. They assessed clinical events including decompensation, hepatocellular carcinoma, liver transplantation and all-cause mortality. To control for disease severity, patients in the study were deemed eligible for interferon, per criteria from the IDEAL peginterferon trial.

SVR, which has been challenged in regard to its association with clinical outcomes, has been confirmed as a prognosis-altering endpoint in patients with hepatitis C virus.

Results of the study showed that among the 1,078 IDEAL-eligible patients, 1,306 treatments occurred, with 52% of patients receiving IFN and 49% receiving DAAs. SVR occurred in 97% of patients receiving DAAs compared with 52% receiving IFN (P < .0001).

The 24-month cumulative event-free survival rate was 99% for IFN and 97% for DAAs with patients who achieved SVR and 96% and 75%, respectively, for patients who did not achieve SVR (P = .01). In addition, SVR correlated with better event-free survival (95% CI, 0.06-0.71).

The event rate at 24 months was 1.1% among patients who received DAAs compared with 3.4% in patients who did not respond to IFN (P = .005), which emphasizes the clinical benefit of higher SVR rates.

“Effectively, we showed that achieving SVR did indeed change the prognosis,” Feld said, noting that it was important to confirm these data because, “if people are going pay a lot of money for medications to achieve high rates of SVR, they need to know that achieving SVR really means something.”

These results, which confirm that SVR is important because it changes the natural history of the disease, mean that this measurement “can no longer be written off as an irrelevant endpoint,” according to Feld.

“People living with HCV should be treated because curing the infection improves outcomes, including survival,” he concluded. “We thought this was true before. This study proves it.” – by Caitlyn Stulpin

Disclosures: Feld reports receiving research funds and consulting fees from Abbott, AbbVie, Gilead, Janssen and Merck and scientific consulting funds from Contravir, Enanta and Roche. Please see the study for all other authors’ relevant financial disclosures.

Jordan J. Feld, D, MPH, FAASLD
Jordan J. Feld

SVR, which has been challenged in regard to its association with clinical outcomes, has been confirmed as a prognosis-altering endpoint in patients with hepatitis C virus, according to findings published in Clinical Infectious Diseases.

As a result, SVR can serve as a surrogate endpoint that results in better clinical outcomes, according to the study results.

“Despite a lot of data showing the benefits of SVR in terms of both liver and non-liver-related outcomes, some have still argued that SVR is not a clinically important endpoint. They have made the case that, although studies have shown that patients who achieve SVR do better than those who do not, it is possible that SVR itself is part of, rather than the cause of, a good prognosis,” Jordan J. Feld, D, MPH, FAASLD, from the University of Toronto University Health Network, told Healio. “In a sense, they are saying that the people who achieved SVR would have done better than those who did not even if they had never been treated.”

Feld and colleagues gathered data from patients beginning treatment with interferon (IFN) or direct-acting antivirals between June 2006 and December 2016. They assessed clinical events including decompensation, hepatocellular carcinoma, liver transplantation and all-cause mortality. To control for disease severity, patients in the study were deemed eligible for interferon, per criteria from the IDEAL peginterferon trial.

SVR, which has been challenged in regard to its association with clinical outcomes, has been confirmed as a prognosis-altering endpoint in patients with hepatitis C virus.

Results of the study showed that among the 1,078 IDEAL-eligible patients, 1,306 treatments occurred, with 52% of patients receiving IFN and 49% receiving DAAs. SVR occurred in 97% of patients receiving DAAs compared with 52% receiving IFN (P < .0001).

The 24-month cumulative event-free survival rate was 99% for IFN and 97% for DAAs with patients who achieved SVR and 96% and 75%, respectively, for patients who did not achieve SVR (P = .01). In addition, SVR correlated with better event-free survival (95% CI, 0.06-0.71).

The event rate at 24 months was 1.1% among patients who received DAAs compared with 3.4% in patients who did not respond to IFN (P = .005), which emphasizes the clinical benefit of higher SVR rates.

“Effectively, we showed that achieving SVR did indeed change the prognosis,” Feld said, noting that it was important to confirm these data because, “if people are going pay a lot of money for medications to achieve high rates of SVR, they need to know that achieving SVR really means something.”

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These results, which confirm that SVR is important because it changes the natural history of the disease, mean that this measurement “can no longer be written off as an irrelevant endpoint,” according to Feld.

“People living with HCV should be treated because curing the infection improves outcomes, including survival,” he concluded. “We thought this was true before. This study proves it.” – by Caitlyn Stulpin

Disclosures: Feld reports receiving research funds and consulting fees from Abbott, AbbVie, Gilead, Janssen and Merck and scientific consulting funds from Contravir, Enanta and Roche. Please see the study for all other authors’ relevant financial disclosures.