Durability of Sustained Virologic Response: 3 year follow-up

DURABILITY OF VIRAL RESPONSE TO INTERFERON RIBAVIRIN COMBINATION IN PATIENTS WITH CHRONIC HEPATITIS C: of 311 SVRs, during 3 years follow-up 7 patients had late relapse
     T. Poynard, J. McHutchison, G. Davis, R. Esteban, J. Albrecht, M. Ling, IHIT. group, Paris, France

The combination of interferon (IFN) and ribavirin (I/R;Rebetron,Schering-Plough) is the standard treatment with higher early sustained response than IFN alone, but there remains little long term follow-up to insure that responses persist.

Aim:
To assess the durability of the 6-month post-treatment ("sustained") virologic response to I/R.

Methods:
2089 patients were enrolled in 4 randomized trials of 24 to 48 weeks of IFN+-R for either naive or IFN relapsers. 455 patients treated by I/R were sustained responders (SR: HCV-RNA negative at the end of treatment and 6 months later). 311 of these SR agreed to participate in long-term follow-up (107 naive treated 24 wks I/R, 147 naive 48 wks I/R and 57 relapsers treated 24 wks I/R. Late relapse rates for SR were reported beginning 6 months after the treatment was stopped Serum HCV RNA was measured by quantitative PCR (NGI, sensitivity <100 copies per ml).

Results:
During 3 years follow-up, 7 patients had a late relapse: 3 patients among naive treated 24wks (none after 2 years), 1 among the naive treated 48wks (none after 2 years),2 among relapsers. The corresponding percentages at 3 years (Kaplan Meier) of patients without late relapse among early SR were 97+/-1.7%, 99+/-1%, and 93%+/-5.1% respectively. No factor was associated with these late relapses (logrank, Cox).

Conclusion:
Few patients with chronic hepatitis C who remain HCV-RNA negative for 6 months following completion of treatment with combination interferon-ribavirin will subsequently relapse. So far among naive patients, no patient had a late relapse after two years of sustained response.