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Sustained Virological Response to Interferon plus Ribavirin Reduces Liver-related Complications and Mortality in HIV/HCV-co-infected Patients by 9-Fold
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Reported by Jules Levin
CROI, Feb 3-6, 2008, Boston
Juan Berenguer*1, J Alvarez-Pellicer2, J Lopez Aldeguer3, M Von-Wichman4, C Quereda5, J Mallolas6, J Sanz7, C Tural8, J Bellon1, J Gonzalez2, and The GESIDA 3603 Study Group
1Hosp Gregorio Maranon, Madrid, Spain; 2Hosp La Paz, Madrid, Spain; 3Hosp La Fe, Valencia, Spain; 4Hosp Donostia, San Sebastian, Spain; 5Hosp Ramon y Cajal, Madrid, Spain; 6Hosp Clin, Barcelona, Spain; 7Hosp Principe de Asturias, Alcala de Henares, Madrid; and 8Hosp Germans Tr’as i Pujol, Badalona, Spain
from Jules: The objective of this study was to determine the effect of achieving an SVR on clinical outcomes including mortality, liver-related complications, and HIV progression in HCV/HIV coinfected patients. Included in this analysis were 11 clinical centers in Spain and 711 coinfected patients who started IFN-RBV or Peg/RBV between Jan 2000 and Dec 2005. 80% of patients received Peg/RBV. Followup was 18-22 months. The death rate was 6.9% among the 493 patients not achieving SVR and .9% among the 218 patients achieving SVR. Liver related complications was 3.7% in non-SVR group vs .5% in SVR group. AIDS related events were .4% in non-SVR group vs 0 in SVR group. Liver decompensation was 9.1% in non-SVR group and .5% in SVR group. Hepatocarcinoma was 1.8% in non-SVR group vs 0 in SVR group. Liver transplantation was 2.2% in non-SVR group and 0 in SVR group.
The rate of overall mortality was 9 times higher in the non-SVR group; the rate of lver-related mortality was 7 times higher in the non0SVR group; liver decompensation was almost 20 times higher in the non-SVR group; new AIDS conditions was 4 times higher in the non-SVR group.
After 5 years of educating Congress (held 4-5 hearings, submitted numerous papers, and had countless meetings in Congressional offices,) and the administration on HCV and coinfection I was successful in getting coinfection language inserted in the Ryan White Care Act despite very little support from the HIV RWCA lobbying groups, particularly those Wash-DC based. The language says programs for coinfected patients should be implemented including treatment education, but there was no money mandated to support the language, perhaps because community support was lacking. Treatment education care/treatment support programs would save lives but HCV knowledge, education and commitment in the HIV community (care & service providers, and city/state administrators) remains inadequate.
ABSTRACT
Background: Little is known about the long-term clinical consequences of achieving a sustained virological response (SVR) following interferon plus ribavirin (IFN-RBV) therapy in HIV/hepatitis C virus (HCV)+ patients.
Methods: We analyzed the GESIDA 3603 Study Cohort, established to follow HIV/HCV+ patients who started IFN-RBV therapy between January 2000 and December 2005 and with active follow-up every 6 months. The primary objective of this cohort was to determine the effect of achieving an SVR on long-term clinical outcomes including liver-related complications, HIV progression, overall mortality, and liver-related mortality.
Results: We analyzed 711 HIV/HCV+ patients: genotypes 1-4 69%, F3-F4 fibrosis 39%, peg-IFN2a-RBV 44%, peg-IFN2b-RBV 38%, and conventional IFN2b-RBV 18%.
SVR was documented in 31%.
Factors independently associated with SVR (reported elsewhere) were CDC clinical category (A-B vs C) and genotype (2-3 vs 1-4). The incidence rates of different events after a median follow-up of 20.8 months (IQR 12.2 to 38.7) are shown in the table.
We performed a Cox regression analysis adjusted for CDC clinical category (A-B vs C), HCV genotype (1-4 vs 2-3) and stage of liver fibrosis (F0-2 vs F3-4).
This showed that failure to achieve an SVR was independently associated with a higher hazard ratio of developing a liver-related event (liver-related mortality / liver decompensation / hepatocarcinoma / liver transplantation): HR 10.22; 95%CI 1.38 to 75.46 (p = 0.023).
Conclusions: Our results suggest that the achievement of an SVR after IFN-RBV therapy in HIV/HCV+ patients reduces liver-related complications and mortality.
After multivariate analysis adjusted hazard ratio of liver related events was 9 times higher (p=.032) for patients not achieving SVR than patients achieving SVR.
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