Abstract
ObjectiveTo evaluate the Fibrosis (FIB)-4 index as a predictor of major liver-related events (LRE) and liver-related death (LRD) in human immunodeficiency virus (HIV) type-1 patients initiating combination antiretroviral therapy (cART).DesignRetrospective analysis of a prospective cohort study.SettingItalian HIV care centers participating to the ICONA Foundation cohort.ParticipantsTreatment-naive patients enrolled in ICONA were selected who: initiated cART, had hepatitis C virus (HCV) serology results, were HBsAg negative, had an available FIB-4 index at cART start and during follow up.MethodsCox regression models were used to determine the association of FIB4 with the risk of major LRE (gastrointestinal bleeding, ascites, hepatic encephalopathy, hepato-renal syndrome or hepatocellular carcinoma) or LRD.ResultsThree-thousand four-hundred seventy-five patients were enrolled: 73.3% were males, 27.2% HCV seropositive. At baseline (time of cART initiation) their median age was 39 years, had a median CD4+ T cell count of 260 cells/uL, and median HIV RNA 4.9 log copies/mL, 65.9% had a FIB-4 <1.45, 26.4% 1.45–3.25 and 7.7% >3.25. Over a follow up of 18,662 person-years, 41 events were observed: 25 major LRE and 16 LRD (incidence rate, IR, 2.2 per 1,000 PYFU [95% confidence interval, CI 1.6–3.0]). IR was higher in HCV seropositives as compared to negatives (5.9 vs 0.5 per 1,000 PYFU). Higher baseline FIB-4 category as compared to <1.45 (FIB-4 1.45–3.25: HR 3.55, 95% CI 1.09–11.58; FIB-4>3.25: HR 4.25, 1.21–14.92) and time-updated FIB-4 (FIB-4 1.45–3.25: HR 3.40, 1.02–11.40; FIB-4>3.25: HR 21.24, 6.75–66.84) were independently predictive of major LRE/LRD, after adjusting for HIV- and HCV-related variables, alcohol consumption and type of cART.ConclusionsThe FIB-4 index at cART initiation, and its modification over time are risk factors for major LRE or LRD, independently of infection with HCV and could be used to monitor patients on cART.
Highlights
Combination antiretroviral therapy had deeply changed the natural history of HIVassociated disorders
Higher baseline FIB-4 category as compared to 3.25: HR 4.25, 1.21–14.92) and time-updated FIB-4 (FIB-4 1.45–3.25: HR 3.40, 1.02–11.40; FIB4>3.25: HR 21.24, 6.75–66.84) were independently predictive of major Liver-related events (LRE)/liver-related death (LRD), after adjusting for human immunodeficiency virus (HIV)- and hepatitis C virus (HCV)-related variables, alcohol consumption and type of Combination antiretroviral therapy (cART)
Liver-related events (LRE) represent a consistent proportion of non-AIDS events, in patients chronically co-infected with hepatitis viruses, and are a relevant cause of death, in HIV-infected populations with high prevalence rates of HCV [2]
Summary
Combination antiretroviral therapy (cART) had deeply changed the natural history of HIVassociated disorders. Liver-related events (LRE) represent a consistent proportion of non-AIDS events, in patients chronically co-infected with hepatitis viruses, and are a relevant cause of death, in HIV-infected populations with high prevalence rates of HCV [2]. FIB-4 was initially developed and validated as a predictor of advanced fibrosis in HIV/HCV coinfected patients [4]. Later, It has been validated in HCV monoinfected individuals where it represents a valid predictor of histologic liver fibrosis stage [5] and subsequent LRE and liver-related death (LRD) [6,7], in some cases with better prognostic value than liver biopsy [8], results are not consistent throughout studies [9]
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