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Sustained Virological Response to Interferon plus Ribavirin Reduces Liver-related Complications and Mortality in HIV/HCV-co-infected Patients
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 Trías i Pujol, Badalona, Spain
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-IFNα2a-RBV
44%, peg-IFNα2b-RBV 38%, and conventional IFNα2b-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).
|
|
Rate/100 person-years
(95%CI)
|
|
|
Event
|
SVR
|
Non-SVR
|
p*
|
|
Overall mortality
|
0.46 (0.06 to1.65)
|
3.12 (2.16 to4.37)
|
0.003
|
|
Liver-related mortality
|
0.23 (0.01 to1.27)
|
1.65 (0.98 to2.61)
|
0.028
|
|
Liver decompensation#
|
0.23 (0.01 to1.27)
|
4.33 (3.16 to5.8)
|
<0.001
|
|
Hepatocarcinoma
|
0 (0 to0.84)
|
0.83 (0.38 to1.58)
|
0.099
|
|
Liver transplantation
|
0 (0 to0.84)
|
1.02 (0.50 to1.82)
|
0.034
|
|
New AIDS conditions
|
0.23 (0.01 to1.27)
|
0.93 (0.44 to1.70)
|
0.144
|
* By log-rank test. # Ascites,
upper gastrointestinal bleeding, hepatic encephalopathy.
Conclusions: Our results
suggest that the achievement of an SVR after IFN-RBV therapy in HIV/HCV+
patients reduces liver-related complications and mortality.
|
