Published: Nov 7, 2013 | Updated: Nov 7, 2013
By Michael Smith, North American Correspondent, MedPage Today
WASHINGTON -- Successful hepatitis C (HCV) treatment before a liver transplant markedly reduced the risk of re-infection, a researcher said here.
Without treatment, HCV re-infection of the transplanted liver is "universal," according to Michael Curry, MD, of Beth Israel Deaconess Medical Center in Boston.
But 64% of patients successfully treated with the investigational agent sofosbuvir along with the standard medication ribavirin remained virus-free 12 weeks after the transplant, Curry reported at the annual meeting of the American Association for the Study of Liver Diseases.
The only predictor for success, he said, was a period of at least 30 days in a row before transplant when HCV could not be detected in the patient.
Curry was also an author on a bookend study, presented earlier at this meeting, that showed that the same agents delivered after transplant can also improve outcomes.
Taken together, the studies hold out hope for HCV patients who need a new liver, commentedMichael Fried, MD, of the University of North Carolina Chapel Hill, who was not part of the study.
Recurrent HCV infection after transplant leads quickly to renewed illness, graft loss, and often death, Fried told MedPage Today. "If you go in viremic, you come out viremic," he said.
Moreover, the post-transplant course of the disease is much faster than it was in the first place, he noted. So "finding strategies to try to prevent re-infection is, of course, very attractive," he said, and transplant specialists are watching these trials with great interest.
Curry reported data on 44 patients who have been transplanted following the drug treatment, of whom 41 had virus below the lower limit of quantification at the time of surgery.
One patient of the 41 has been lost to follow-up and another has not reached the 12-week follow-up after surgery, Curry reported, but of the remaining 39, 25 have undetectable virus.
In a multivariate analysis, the only factor that predicted success, Curry said, was the continuous length of time in the run-up to transplant in which the virus could not be detected.
For each such day, the odds ratio for avoiding re-infection rose 4%, he said -- an odds ratio of 1.042 (95% CI 1.012-1.083, P=0.0007.)
Indeed, of the 25 patients who remain virus-free 12 weeks after transplant, all but five had more than 30 days "target not detected," Curry said.
In contrast, only one patient whose HCV recurred had more than 30 days without the virus being detected.
The study, Fried said, seems to show clearly that: "If you can get people virus-negative for at least 30 days prior to their transplant, they have an extremely low risk of having recurrence."
But he cautioned that the numbers in the study are small and it's "hard to make set judgments on 30 or 40 patients."
But if sofosbuvir is approved, he said, it's very likely that transplant centers will be eager try it out, which will quickly yield better real-world data on outcomes and any possible problems.
- Gilead Announces Phase 2 Results for Sofosbuvir-Based Regimens in Hepatitis C Patients Before and After Liver Transplantation
- First Study of Its Kind Shows That All-oral Treatment Regimen Prevents Hepatitis C Recurrence in Liver Transplant Recipients Who Received Allografts
- Initial Evaluation of the Sofosbuvir Compassionate Use Program for Patients with Severe Recurrent HCV Following Liver Transplantation