The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real‐life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE‐Lombardia registry). In a subset (n = 748), liver stiffness measurement (LSM) was available at baseline and follow‐up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03‐1.09) and diabetes (OR 2.01 [1.65‐2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35‐0.60]; P < 0.0001 for all). The impact of BMI was greater in those without diabetes (P = 0.003). Diabetes was independently associated with less pronounced LSM improvement after viral eradication (P = 0.001) and in patients with advanced fibrosis was an independent predictor of the most frequent clinical events, namely de novo hepatocellular carcinoma (HCC; hazard ratio [HR] 2.09 [1.20‐3.63]; P = 0.009) and cardiovascular events (HR 2.73 [1.16‐6.43]; P = 0.021). Metformin showed a protective association against HCC (HR 0.32 [0.11‐0.96]; P = 0.043), which was confirmed after adjustment for propensity score (P = 0.038). Diabetes diagnosis further refined HCC prediction in patients with compensated advanced chronic liver disease at high baseline risk (P = 0.024). Conclusion: Metabolic comorbidities were associated with advanced liver fibrosis at baseline, whereas statins were protective. In patients with advanced fibrosis, diabetes increased the risk of de novo HCC and of cardiovascular events. Optimization of metabolic comorbidities treatment by a multi‐disciplinary management approach may improve cardiovascular and possibly liver‐related outcomes.
Background & Aims
In the direct‐acting antiviral era, treatment of genotype‐3 HCV (HCV‐GT3) is still challenging. Real‐life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap.
Methods
Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV‐GT3 patients consecutively treated within the Lombardia web‐based Navigatore HCV‐Network; differences in SVR12 across regimens were evaluated by logistic regression.
Results
Of the 2082 subjects with HCV‐GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV‐positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV‐RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P = .065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P = .007) and lower median pretreatment Log10HCV‐RNA (5.87 vs 6.20, P = .001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV‐RNA were independently associated with SVR12.
Conclusions
In a large real‐life setting of HCV‐GT3‐infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier‐to‐treat patients allows ribavirin‐free and shorter schedules without mining SVR12 in this <
Of 242 north Italian heroin addicts, 24 (9.9%) were HBsAg positive. HBeAg was positive in two of them (8.3%), anti-HBe in 16 (66.6%) and anti-HDV in 21 (87.5%). Of the 218 HBsAg negative, 182 (83.5%) had anti-HBc, 72 (33.0%) anti-HBe and 97 (44.5%) anti-HBs. One-hundred-eighty-five drug addicts were anti-HIV positive (76.4%); 77 of these (41.6%) were asymptomatic, 93 (50.3%) had PGL and 15 (8.1%) ARC. T4+ cell count was significantly lower in subjects with ARC as was T4+/T8+ ratio in subjects with PGL and ARC. During a median follow-up of 9.5 months (range 4-25), we observed three new cases of hepatitis (two caused by NANBV and one by HBV with HDV coinfection) and one new HIV infection. Ten anti-HIV positive subjects developed PGL and one AIDS.
Three hundred and two intravenous drug addicts (IVDA) from five towns in Northeastern Italy were studied. Of the males, 37/249 (14.8%) were homosexuals and of the females, 29/53 (54.7%) were prostitutes; 118 (39.0%) were alcoholics. AST levels were abnormal in 31.8%, ALT in 45.7%, GTP in 36.4%, and bilirubin in 14.6%. The prevalence of HBsAg (13.9%) and HBeAg (21.4% of HBsAg positive) was significantly higher than in 2,983 controls (4.2% and 6.3%, p less than .001 and p less than .02, respectively). Of the HBsAg positive subjects, 51.7% had anti-HDV antibodies. Among 260 HBsAg negative cases, 146 (56.2%) were anti-HBs and anti-HBc positive, 76 (29.2%) were anti-HBc positive and anti-HBs negative (25 anti-HBe positive and 51 anti-HBe negative), and 38 had no HBV markers. Anti-HIV ELISA positive subjects came to 70.5% (triplicate determination with absolute concordance) and Western blot analysis confirmed the results in 99.1% of ELISA positive and 100% of ELISA negative subjects. The prevalence of anti-HIV was significantly higher in anti-HBc positive than negative cases (p less than .02), even excluding HBsAg positive subjects. Cases negative for HIV and HBV had a significantly lower median duration of drug abuse than those with past or present infection (36 vs 60 months, p less than .001). HIV-related diseases were present in 56.3% of the cases (120/213; PGL in 94, ARC in 24, and AIDS in two).(ABSTRACT TRUNCATED AT 250 WORDS)
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