G Vourli1, G Papatheodoridis2, M Raptopoulou3, G N Dalekos4, A Hounta5, G Nikolopoulou6, I Zouboulis-Vafeiadis7, E Manesis8, G Kitis9, C Gogos10, I Ketikoglou11, G Hatzis12, T Vasilialdis13, S Karatapanis14, K Mimidis15, C Drakoulis16, G Touloumi1. 1. Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece. 2. Department of Gastroenterology, Athens University Medical School, "Laiko" General Hospital of Athens, Athens, Greece. 3. 4 Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece. 4. Department of Medicine & Research Laboratory of Internal Medicine, School of Medicine, University of Thessaly, Larissa, Greece. 5. 4 Department of Internal Medicine, General University Hospital "Attikon", Athens, Greece. 6. Viral Hepatitis Committee, KEELPNO, Athens, Greece. 7. First Department of Propaedeutic Medicine, Athens University Medical School "Laiko" General Hospital of Athens, Athens, Greece. 8. Division of Internal Medicine, Athens University Medical School, Athens, Greece. 9. Gastroenterology Clinic, General Hospital "G. Papanikolaou", Thessaloniki, Greece. 10. Department of Infectious Diseases, Patras University Hospital, Patras, Greece. 11. Department of Internal Medicine, "Hippocration" General Hospital, Athens, Greece. 12. Department of Pathophysiology, University of Athens, Athens, Greece. 13. 3Department of Internal Medicine, Aristotle University of Thessaloniki, "Papageorgiou" Hospital, Thessaloniki, Greece. 14. Department of Internal Medicine, General Hospital of Rhodes, Rhodes, Greece. 15. Department of Medicine, Democritus University of Thrace, Alexandroupolis, Greece. 16. 2 Department of Internal Medicine, General Hospital of Nikaia, Athens, Greece.
Abstract
BACKGROUND AND AIMS: Although effective treatment in terms of inducing virological and biochemical response for chronic hepatitis B (CHB) is available, its effect on the clinical course of the disease has not yet been accurately estimated. Objective of this study was to evaluate the effect of antiviral therapy and its type [interferon +/- nucleos(t)ide analogs (NAs) vs. NAs] on the occurrence of a clinical event (liver decompensation, liver transplant, hepatocellular carcinoma and death from a liver-related cause) in CHB patients. METHODS: The study population was derived from the HEPNET-Greece, a nationwide cohort study aimed to evaluate the current epidemiological course of viral hepatitis. To account for time-dependent confounding, Cox marginal structural models were used to analyze data. RESULTS: Thirty out of 2,125 eligible patients experienced a clinical event during their follow-up. When comparing treated to untreated individuals, the hazard ratio (HR) for a clinical event was 0.39 (95% CI: 0.16-0.98; p =0.044) in the whole sample, whereas there were indications of a more intense effect in the subgroup of patients with cirrhosis at presentation (HR =0.16, 95% CI: 0.02-1.21; p =0.075). The effect of Interferon initiated treatment was not significantly different of that of NAs. There was some evidence, albeit not statistically significant, of a protective treatment effect on hepatocellular carcinoma development (HCC). CONCLUSIONS: Data from observational studies can provide useful inference, provided they are analyzed appropriately. The current study has shown that the available treatment options for CHB offer a significant clinical benefit to CHB infected individuals. Hippokratia 2016, 20(3): 214-221.
BACKGROUND AND AIMS: Although effective treatment in terms of inducing virological and biochemical response for chronic hepatitis B (CHB) is available, its effect on the clinical course of the disease has not yet been accurately estimated. Objective of this study was to evaluate the effect of antiviral therapy and its type [interferon +/- nucleos(t)ide analogs (NAs) vs. NAs] on the occurrence of a clinical event (liver decompensation, liver transplant, hepatocellular carcinoma and death from a liver-related cause) in CHB patients. METHODS: The study population was derived from the HEPNET-Greece, a nationwide cohort study aimed to evaluate the current epidemiological course of viral hepatitis. To account for time-dependent confounding, Cox marginal structural models were used to analyze data. RESULTS: Thirty out of 2,125 eligible patients experienced a clinical event during their follow-up. When comparing treated to untreated individuals, the hazard ratio (HR) for a clinical event was 0.39 (95% CI: 0.16-0.98; p =0.044) in the whole sample, whereas there were indications of a more intense effect in the subgroup of patients with cirrhosis at presentation (HR =0.16, 95% CI: 0.02-1.21; p =0.075). The effect of Interferon initiated treatment was not significantly different of that of NAs. There was some evidence, albeit not statistically significant, of a protective treatment effect on hepatocellular carcinoma development (HCC). CONCLUSIONS: Data from observational studies can provide useful inference, provided they are analyzed appropriately. The current study has shown that the available treatment options for CHB offer a significant clinical benefit to CHB infected individuals. Hippokratia 2016, 20(3): 214-221.
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