THE USE OF NEW ANTIVIRAL DRUGS FOR THE TREATMENT OF HEPATITIS C VIRUS (HCV) INFECTION IN PATIENTS WITH THALASSAEMIA: PRELIMINARY DATA ON SAFETY AND EFFICACY.
(Abstract release date: 05/19/16)
EHA Library. Ricchi P. 06/09/16; 135032; PB2132
Dr. Paolo Ricchi
Contributions
Contributions
Abstract
Abstract: PB2132
Type: Publication Only
Background
Several adult patients with thalassaemia major (TM) and talassaemia intermedia (TI) following the failure of combination therapy with pegylated interferon (PEG-IFN) and ribavirin are still affected by Hepatitis C virus (HCV) infection and need to be treated with new antiviral drug. To date, no data are available on interaction between chelation treatment and new antiviral drugs.
Aims
Here we report our preliminary data on their efficacy and safety during different chelation treatments on the first four weeks of antiviral therapy.
Methods
Since December 2015, 17 patients with TM, 2 with TI, 2 with sickle cell/thalassaemia were considered for treatment. Twelve received Ledipasvir-Sofosbuvir, 7 Ledipasvir-Sofosbuvir-ribavirin, 1 sofosbuvir-ribavirin, one daclatasvir-sofosbuvir. All patients but three, were and continued to be under chelation treatment: five were under deferasirox (DFX), 3 under deferiprone (DFP), 2 under desferioxamine (DFO), 6 under alternate DFO/DFP, 1 under DFO and DFX combined treatment. During the first four weeks of therapy all patients had weekly monitoring of serum ferritin, liver enzymes, creatinin level, complete blood count and biweekly monitoring HCV RNA copies.
Results
All treatments were very well tolerated; patients receiving ribavirin still not presented significant increase in blood transfusion requirements. Following one week of treatment liver enzyme decreased significantly from baseline: mean ± SD alanine transaminase (ALT) and aspartate transaminase (AST) decreased from 103 ± 127 to 35 ± U/L (p=0.03) and from 83 ± 85 to 33 ± 27 (p=0.02) U/L, respectively; mean ± SD ferritin level and HCV RNA copies decreased from 1556 ± 1436 to 1334 ± 1355 ng/ml (p=0.68) and from 1,650000 ± 1472378 to 0 copies/ml (p=0.000014). A further decline was observed at fourth weeks in mean (± SD) ALT, AST and ferritin level which dropped to 28 ± 29 U/L (p=0.02), 30 ± 20 U/L(p=0.01) and 1058 ± 1011 ng/ml (p=0.26), respectively. No increase in glomerural filtration rate (GFR) and impairment in urinary albumin/creatinine ratio were observed among patients treated with DFX with respect to basal level. No event of neutropenia and agranulocytosis neither reduction in neutrophil count with respect to basal level occurred among patients treated with DFP
Conclusion
All treatments were effective in promptly drop viral copying. The observed reduction in ferritin level is likely linked to reduced hepatic lysis and shouldn't be used to modify chelation therapy. Our opening data show that chelation treatment is feasible and safe. The termination of treatments and further studies on larger population are needed to confirm these preliminary observations
Session topic: E-poster
Keyword(s): Chelation, Hepatitis C virus, Safety
Type: Publication Only
Background
Several adult patients with thalassaemia major (TM) and talassaemia intermedia (TI) following the failure of combination therapy with pegylated interferon (PEG-IFN) and ribavirin are still affected by Hepatitis C virus (HCV) infection and need to be treated with new antiviral drug. To date, no data are available on interaction between chelation treatment and new antiviral drugs.
Aims
Here we report our preliminary data on their efficacy and safety during different chelation treatments on the first four weeks of antiviral therapy.
Methods
Since December 2015, 17 patients with TM, 2 with TI, 2 with sickle cell/thalassaemia were considered for treatment. Twelve received Ledipasvir-Sofosbuvir, 7 Ledipasvir-Sofosbuvir-ribavirin, 1 sofosbuvir-ribavirin, one daclatasvir-sofosbuvir. All patients but three, were and continued to be under chelation treatment: five were under deferasirox (DFX), 3 under deferiprone (DFP), 2 under desferioxamine (DFO), 6 under alternate DFO/DFP, 1 under DFO and DFX combined treatment. During the first four weeks of therapy all patients had weekly monitoring of serum ferritin, liver enzymes, creatinin level, complete blood count and biweekly monitoring HCV RNA copies.
Results
All treatments were very well tolerated; patients receiving ribavirin still not presented significant increase in blood transfusion requirements. Following one week of treatment liver enzyme decreased significantly from baseline: mean ± SD alanine transaminase (ALT) and aspartate transaminase (AST) decreased from 103 ± 127 to 35 ± U/L (p=0.03) and from 83 ± 85 to 33 ± 27 (p=0.02) U/L, respectively; mean ± SD ferritin level and HCV RNA copies decreased from 1556 ± 1436 to 1334 ± 1355 ng/ml (p=0.68) and from 1,650000 ± 1472378 to 0 copies/ml (p=0.000014). A further decline was observed at fourth weeks in mean (± SD) ALT, AST and ferritin level which dropped to 28 ± 29 U/L (p=0.02), 30 ± 20 U/L(p=0.01) and 1058 ± 1011 ng/ml (p=0.26), respectively. No increase in glomerural filtration rate (GFR) and impairment in urinary albumin/creatinine ratio were observed among patients treated with DFX with respect to basal level. No event of neutropenia and agranulocytosis neither reduction in neutrophil count with respect to basal level occurred among patients treated with DFP
Conclusion
All treatments were effective in promptly drop viral copying. The observed reduction in ferritin level is likely linked to reduced hepatic lysis and shouldn't be used to modify chelation therapy. Our opening data show that chelation treatment is feasible and safe. The termination of treatments and further studies on larger population are needed to confirm these preliminary observations
Session topic: E-poster
Keyword(s): Chelation, Hepatitis C virus, Safety
Abstract: PB2132
Type: Publication Only
Background
Several adult patients with thalassaemia major (TM) and talassaemia intermedia (TI) following the failure of combination therapy with pegylated interferon (PEG-IFN) and ribavirin are still affected by Hepatitis C virus (HCV) infection and need to be treated with new antiviral drug. To date, no data are available on interaction between chelation treatment and new antiviral drugs.
Aims
Here we report our preliminary data on their efficacy and safety during different chelation treatments on the first four weeks of antiviral therapy.
Methods
Since December 2015, 17 patients with TM, 2 with TI, 2 with sickle cell/thalassaemia were considered for treatment. Twelve received Ledipasvir-Sofosbuvir, 7 Ledipasvir-Sofosbuvir-ribavirin, 1 sofosbuvir-ribavirin, one daclatasvir-sofosbuvir. All patients but three, were and continued to be under chelation treatment: five were under deferasirox (DFX), 3 under deferiprone (DFP), 2 under desferioxamine (DFO), 6 under alternate DFO/DFP, 1 under DFO and DFX combined treatment. During the first four weeks of therapy all patients had weekly monitoring of serum ferritin, liver enzymes, creatinin level, complete blood count and biweekly monitoring HCV RNA copies.
Results
All treatments were very well tolerated; patients receiving ribavirin still not presented significant increase in blood transfusion requirements. Following one week of treatment liver enzyme decreased significantly from baseline: mean ± SD alanine transaminase (ALT) and aspartate transaminase (AST) decreased from 103 ± 127 to 35 ± U/L (p=0.03) and from 83 ± 85 to 33 ± 27 (p=0.02) U/L, respectively; mean ± SD ferritin level and HCV RNA copies decreased from 1556 ± 1436 to 1334 ± 1355 ng/ml (p=0.68) and from 1,650000 ± 1472378 to 0 copies/ml (p=0.000014). A further decline was observed at fourth weeks in mean (± SD) ALT, AST and ferritin level which dropped to 28 ± 29 U/L (p=0.02), 30 ± 20 U/L(p=0.01) and 1058 ± 1011 ng/ml (p=0.26), respectively. No increase in glomerural filtration rate (GFR) and impairment in urinary albumin/creatinine ratio were observed among patients treated with DFX with respect to basal level. No event of neutropenia and agranulocytosis neither reduction in neutrophil count with respect to basal level occurred among patients treated with DFP
Conclusion
All treatments were effective in promptly drop viral copying. The observed reduction in ferritin level is likely linked to reduced hepatic lysis and shouldn't be used to modify chelation therapy. Our opening data show that chelation treatment is feasible and safe. The termination of treatments and further studies on larger population are needed to confirm these preliminary observations
Session topic: E-poster
Keyword(s): Chelation, Hepatitis C virus, Safety
Type: Publication Only
Background
Several adult patients with thalassaemia major (TM) and talassaemia intermedia (TI) following the failure of combination therapy with pegylated interferon (PEG-IFN) and ribavirin are still affected by Hepatitis C virus (HCV) infection and need to be treated with new antiviral drug. To date, no data are available on interaction between chelation treatment and new antiviral drugs.
Aims
Here we report our preliminary data on their efficacy and safety during different chelation treatments on the first four weeks of antiviral therapy.
Methods
Since December 2015, 17 patients with TM, 2 with TI, 2 with sickle cell/thalassaemia were considered for treatment. Twelve received Ledipasvir-Sofosbuvir, 7 Ledipasvir-Sofosbuvir-ribavirin, 1 sofosbuvir-ribavirin, one daclatasvir-sofosbuvir. All patients but three, were and continued to be under chelation treatment: five were under deferasirox (DFX), 3 under deferiprone (DFP), 2 under desferioxamine (DFO), 6 under alternate DFO/DFP, 1 under DFO and DFX combined treatment. During the first four weeks of therapy all patients had weekly monitoring of serum ferritin, liver enzymes, creatinin level, complete blood count and biweekly monitoring HCV RNA copies.
Results
All treatments were very well tolerated; patients receiving ribavirin still not presented significant increase in blood transfusion requirements. Following one week of treatment liver enzyme decreased significantly from baseline: mean ± SD alanine transaminase (ALT) and aspartate transaminase (AST) decreased from 103 ± 127 to 35 ± U/L (p=0.03) and from 83 ± 85 to 33 ± 27 (p=0.02) U/L, respectively; mean ± SD ferritin level and HCV RNA copies decreased from 1556 ± 1436 to 1334 ± 1355 ng/ml (p=0.68) and from 1,650000 ± 1472378 to 0 copies/ml (p=0.000014). A further decline was observed at fourth weeks in mean (± SD) ALT, AST and ferritin level which dropped to 28 ± 29 U/L (p=0.02), 30 ± 20 U/L(p=0.01) and 1058 ± 1011 ng/ml (p=0.26), respectively. No increase in glomerural filtration rate (GFR) and impairment in urinary albumin/creatinine ratio were observed among patients treated with DFX with respect to basal level. No event of neutropenia and agranulocytosis neither reduction in neutrophil count with respect to basal level occurred among patients treated with DFP
Conclusion
All treatments were effective in promptly drop viral copying. The observed reduction in ferritin level is likely linked to reduced hepatic lysis and shouldn't be used to modify chelation therapy. Our opening data show that chelation treatment is feasible and safe. The termination of treatments and further studies on larger population are needed to confirm these preliminary observations
Session topic: E-poster
Keyword(s): Chelation, Hepatitis C virus, Safety
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