- Email: [email protected]
Rapid liver fibrosis regression after sustained virological response in HCV patients treated with direct acting antivirals
POSTER PRESENTATIONS Background and Aims: Chronic Hepatitis C, the leading cause of liver disease, infects more than 185 million people worldwide. Ideally, inhibitors should target different steps of the HCV infectious cycle, entry, replication, and assembly/secretionandbe efficient against all HCV genotypes. Therefore, the development of novel, bettertolerated, and more-effective anti-HCV agents is urgently needed. The novel patented EHCV (Catvira) formulation composed of Sofosbuvir 400 mg/Ribavirin 1000 mg/Epigallocatechin Gallate 400 mg (EGCG) was developed. Catvira formulation incorporated EGCG for its anti-hemolytic and effective inhibitory activity against viral entry into human host cells. We evaluated the efficacy and safety ofa single daily fixed dose EHCV (Catvira) in comparison to the standard of care(Sofosbuvir 400 mg + Ribavirin 1000 mg)multiple tablets per day in CHC genotype 4 patients. Methods: Randomized open-label study was carried out on treatment-naïveandtreatment-experienced patientswith genotype 4 HCV infection (No. = 80) were randomly assigned to receive a single daily fixed dose EHCV (40 patients) or the standard of care Sofosbuvir + Ribavirin (40 patients) daily for 12 or 24 weeks. The trial has been registered at clinicaltrials.gov on June 19, 2015 at https:// clinicaltrials.gov/ct2/show/NCT02483156?term=ehcv&rank=1 Results: SVR 12 and SVR 24 for EHCV (Catvira) showed no statistical significant difference when compared to the standard of care (P < 0.1 & P < 0.2 respectively). Also EHCV (Catvira) demonstrated a much faster rate of viral load decline (P < 0.01) which could be due to effective viral entry inhibition into human host cells by EGCG. Moreover EHCV (Catvira) did not affect RBCs count or Hemoglobin levels as compared to the standard of care that resulted in a significant decline (P < 0.05) in both parameters after 24 weeks of treatment. This could be attributed to the anti-hemolytic effect of EGCG. Conclusions: Catvira, administered daily for 12 or 24 weeks, is safe and effective in both naïve and treatment experienced patients with genotype 4 HCV. Catvira’s anti-viral-entry mechanism may also play a role in enhancing effeciay over the standard of care. In addition to potentially ehanced efficacy, Catvira’s anti-hemolytic activity may improve the safety and tolerability of the therapy. Being a single daily dose of Catvira is another advantage leading to better compliance. FRI-207 Active versus passive follow-up examination of patients with chronic hepatitis C during Sofosbuvir/Ledipasvir treatment G. Jargalsaikhan1, B. Dashtseren1,2, B. Dendev1,2, M. Enkhbat1, P. Bat-Ulzii1, D. Boldbaatar1, Z. Genden1, D. Yagaanbuyant2, A. Dagvadorj2, A. Bungert2, N. Dashdorj2, N. Dashdorj1,2. 1Liver Center; 2 Onom Foundation, Ulaanbaatar, Mongolia E-mail: [email protected] Background and Aims: In Mongolia, Sofosbuvir/Ledipasvir (SOF/ LED) was officially approved for the treatment of people with HCV chronic infection in April of 2015 and branded and generic versions were made available in January and May of 2016, respectively. As of September 2016, 4,681 patients had received SOF/LED treatment. However, some these patients did not undergo regular follow-up examinations during the treatment because of cost and other concerns. In this study, we aim to assess differences in sustained viral response (SVR) between the active and passive follow-up groups. Methods: We selected a total of non-cirrhotic 80 patients (aged 54.7 ± 12.03, 51 female, 29 male) who received SOF/LED combination. Inclusion criteria of this study was an APRI score of less than 2.0 or a FIB-4 score of less than 3.25. This group of 80 patients was divided into 2 groups, namely active and passive follow-up. In the active follow-up group, we determined clinical and biochemical parameters and HCV-RNA prior to the start of the treatment, at the 4th week and the 12th week of treatment. In the passive follow-up group, we determined clinical and biochemical parameters and HCV-RNA only at the beginning of the treatment. In both the active and passive
follow-up groups, we determined SVR for all patients 12 weeks after the end of the treatment (EOT). Results: All patients (100%) achieved SVR at 12 weeks after the EOT. Virological and functional outcomes of the patients are shown in Table 1. AST and ALT levels, and APRI and FIB-4 scores decreased significantly during treatment ( p < 0.001) in the active follow-up group.
Conclusions: Antiviral treatment with SOF/LED enabled elimination of HCV in patients without cirrhosis. Successful treatment was associated with significant improvement of the enzymatic liver function. There was no difference of SVR rate between the active versus passive follow-up groups. Relinquishing active follow-up during treatment may be an option for patients without cirrhosis. This can increase access to HCV cure in a country like Mongolia, where costs for diagnostics are at a similar level as treatment. FRI-208 Rapid liver fibrosis regression after sustained virological response in HCV patients treated with direct acting antivirals G.M. Lledó Ibáñez1, A. Arias1, L.M. Benítez-Gutiérrez1, M.J. Cítores2 on behalf of Health Research Institute, I. Carrasco2 on behalf of Health Research Institute, V. Cuervas-Mons1, C. De Mendoza2 on behalf of Health Research Institute. 1Internal Medicine; 2Health Research Institute, Hospital Puerta de Hierro, Madrid, Spain E-mail: [email protected] Background and Aims: Treatment with Direct Antiviral Drugs (DAA) results in HCV eradication in more than 90% of treated individuals. HCV clearance had been associated with improved liver function and hepatic fibrosis using interferon-based regimens. Herein, we report outcomes in hepatic fibrosis following SVR12 using DAA therapy. Methods: All HCV-infected patients treated with DAA at a reference clinic in Madrid were examined. Transient elastometry (FibroScan) was performed at baseline and after 12 weeks of completion of therapy, at the time of assessing sustained virological response (SVR12). Liver fibrosis regression was defined as a shift from advanced fibrosis (Metavir F3-F4 {>9.5 KPa}) to null-mild fibrosis (F0-F2) and/or reduction >2 KPa from any baseline value. As reference, APRI and FIB-4 scores were similarly calculated at these time points. Results: A total of 175 patients were treated with DAA and achieved SVR12. Overall, 97 (55.7%) were naïve for HCV therapy, 29% were liver transplant recipients and 36% were coinfected with HIV. At baseline 61.3% had significant liver fibrosis (F3-F4) with a median FibroScan of 17.9 KPa. In this group, FIB4 and APRI scores were 4.8 and 1.8; respectively. At the time of SVR12, a mean reduction of 3.7 KPa ( p = 0,001) was found, along with a drop to FIB4 1.5 ( p = 0.029) and APRI 0.99 ( p = 0.012). Greater improvements were seen in patients with significant liver fibrosis at baseline (F3-F4), with a mean drop of 5.6 KPa (FibroScan), to 2.1 (FIB4) and to 1.4 (APRI) ( p < 0.01 in all cases). Globally, ≥1 grade in Metavir score was noticed in 36.4% of individuals.
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POSTER PRESENTATIONS No relationship was found between significant improvements in liver fibrosis and IL28B-CC, baseline serum HCV-RNA, OLT, HIV coinfection, HCV genotype, DAA treatment modality and ribavirin use. Conclusions: Most patients with SVR12 using DAA therapy experience a rapid and significant reduction in liver fibrosis, as assessed using elastometry, FIB4 and/or APRI. A benefit on morbidity and mortality should be expected over time in this population. FRI-209 Platelets represent an independent predictor of sustained virological response (SVR) in patients with advanced chronic hepatitis C (CHC) treated with current direct acting antiviral(s) (DAA). HERACLIS: Hellenic multicenter real-life cohort study G. Papatheodoridis1, A. Kapatais2, E. Sinakos3, I. Elefsiniotis4, J. Goulis3, M. Deutsch5, J. Vlachogiannakos1, G. Dalekos6, J. Koskinas5, S. Karatapanis7, M. Schina8, E. Manesis9, I. Ketikoglou5, V. Sevastianos10, C. Triantos11, E. Cholongitas3, M.-V. Papageorgiou1, A. Kourikou12, T. Karaoulani 2, E. Evangelidou4, A. Koukoufiki3, D. Karagiannakis1, N. Gatselis6, M. Tampaki5, G. Ntetskas7, C. Tsolias11, T. Voulgaris13, P. Ioannidou1, E. Akriviadis3, S. Manolakopoulos1,5. 1 Department of Gastroenterology, National & Kapodistrian University of Athens, Laiko General Hospital, Athens; 2Department of Internal Medicine, General Hospital Nikaia-Piraeus Agios Panteleimon, General Hospital of Western Attica Agia Varvara, Piraeus; 34th Department of Internal Medicine, Hippokratio Hospital, Aristotle University, Thessaloniki; 4University Department of Internal MedicineHepatogastroenterology Unit, General and Oncology Hospital of Kifisia Agioi Anargyroi; 52nd Department of Internal Medicine, National & Kapodistrian University of Athens, Hippokratio General Hospital, Athens; 6 Department of Medicine and Research Laboratory of Internal Medicine, School of Medicine, University of Thessaly, Larissa; 71st Department of Internal Medicine, General Hospital of Rhodes, Rhodes; 83rd Department of Internal Medicine, Evangelismos General Hospital; 9Liver Unit, Euroclinic SA; 104th Department of Internal Medicine and Liver Outpatient Clinic, Evangelismos General Hospital, Athens; 11Department of Gastroenterology, University Hospital of Patras, Patras; 122nd Department of Internal Medicine, National & Kapodistrian University of Athens, Laiko General Hospital; 134th Department of Internal Medicine, Evangelismos General Hospital, Athens, Greece E-mail: [email protected] Background and Aims: DAA have been increasingly used over the last years, since they were shown to be very effective and safe in several phase III trials. However, their efficacy may be lower in patients ( pts) with advanced liver disease treated in routine clinical practice. In the HERACLIS ongoing multicenter cohort study involving most of the Greek tertiary liver centers, we assessed the rates and predictors of SVR in CHC pts treated with currently recommended DAA regimens. Methods: We included all CHC pts who have been treated with DAA regimens recommended by EASL in early 2016. All pts fulfilled the national criteria for treatment reimbursement with DAA [F3 experienced, F4, decompensated cirrhosis (Ci), liver transplantation, severe extrahepatic manifestation]. Efficacy was estimated by SVR12. Results: In total, 604 pts (males: 58%, age: 57 ± 11 years, BMI: 26 ± 4 Kg/m2) were included (GT1a: 11%, GT1b: 35%, GT2: 5%, GT3: 24%, GT4: 24%, GT5: 1%). The severity of liver disease was F0-F2 in 5%, F3 in 21%, F4 in 64% and decompensated Ci in 10% of pts. Most pts (67%) were treatment-experienced [( peg)IFNa ± RBV: 72%, peg-IFNa + RBV + BOC/TPV 15%, SOF based regimens 13%]. SOF + SMV ± RBV, SOF + DCV ± RBV, SOF/LDV ± RBV or 3D ± RBV were given in GT1, SOF + RBV ± pegIFNa or SOF + DCV ± RBV in GT2/3, SOF + RBV ± pegIFNa, SOF + SMV ± RBV, SOF + DCV ± RBV, SOF/LDV ± RBV or 2D + RBV in GT4 and SOF(/LDV) + RBV in GT5 pts. At the time of analysis, SVR12 data were available for 500 (83%) pts. SVR was achieved in 440 (88%) pts and was lower in GT3 (90/119 or 76%) than non-GT3 cases (350/381 or 92%, p < 0.001), in those with decompensated cirrhosis (40/53 or 76%) than with F4 (278/317 or 88%) or F0–3 fibrosis (122/130 or 94%) S502
( p = 0.002) and in patients with platelets (PLT) ≤100 (93/121 or 77%) than >100 × 103/mm3 (347/379 or 92%, p < 0.001). Logistic regression analysis showed that lower SVR rate was independently associated with GT3 (OR: 0.37, 95%CI: 0.17–0.62; p = 0.014) and PLT ≤ 100 × 103 (OR: 0.51, 95%CI: 0.27–0.98; p = 0.043), but not with DAA regimen or therapy duration. Similar findings were observed only in F4 pts, while SVR rates were similar in F4 pts with PLT ≤ 100 × 103 (57/73 or 78%) and pts with decompensated cirrhosis (40/53 or 76%, p = 0.897). Conclusions: In our real-world cohort including mostly treatment experienced CHC pts with advanced liver disease, the efficacy of currently recommended DAA regimens is decreasing in pts with GT3 and/or PLT ≤ 100 × 103/mm3. F4 pts with PLT ≤ 100 × 103/mm3 show similarly low SVR rates with those in pts with decompensated cirrhosis. FRI-210 An outbreak of acute hepatitis C GT1b in onco-hematological patients. Treatment with Sofosbuvir + Ledipasvir and concomitant chemotherapy G. Brancaccio1, M.C. Sorbo2, F. Frigeri3, V. Rizzo4, M. Cantone4, F. Genderini5, L. Fabeni6, A. Pinto3, C.F. Perno6, F. Ceccherini-Silberstein 7, G.B. Gaeta8. 1Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Naples; 2Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy, Tor Vergata, Rome; 3Hematology Department, National Cancer Institute “Fondazione Pascale”, Naples; 4Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Italy; 5Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Naples, Italy; 6Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome; 7Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome; 8Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Rome, Italy E-mail: [email protected] Background and Aims: A short course of antiviral agents has been proven active in acute hepatitis C (AHC) in immunocompetent patients. We report treatment of AHC in patients with oncohematological disease (OHD). Methods: Between January and February 2016, 6 patients with hematological malignances developed marked ALT elevation. AHC was diagnosed by the appearance of serum HCV RNA. All patients received SOF + LDV at standard dose for 8 weeks. Sanger sequencing and phylogenetic analysis of the HCV core/NS3/NS5A/NS5B were performed in 5 patients. Results: All patients (3 males; age 25–57 years) were diagnosed with AHC genotype 1b. OHD were: Peripheral T cell lymphoma; T-cell lymphoblastic lymphoma; Follicular lymphoma; Primary mediastinal diffuse large B cell lymphoma(2); multiple plasmoblastic myeloma; 3 patients had accomplished the chemotherapeutic cycles 4–8 weeks before, 3 patients were on active treatment, that was stopped. Laboratory values were (range): ALT 183–1128 IU/L; GGT 68–1089 IU/L; Total Bilirubin 1.1–11.4 mg/dL; HCV-RNA 2 × 105– 6 × 107 IU/mL; anti-HCV negative. SOF + LDV was started at standard dose. At week 1 ALT values ranged 45–190 IU/L and HCV-RNA was undetectable in 1/6 patients. At week 4, 3 patients were viremic and at week 6 presented HCV-RNA below the limit of detection; in these patients antiviral therapy was extended to 12 weeks. At the end of therapy HCV was undetectable in all patients; at week 4 post-therapy HCV-RNA was undetectable in all; one patient died at week 6 post therapy due to progression of the onco-hematological disease; 5 patients had HCV-RNA undetectable at week 12 post therapy. Three patients re-started chemotherapy* between week 2 and 6 of antiviral treatment. Two additional patients died after week 12 post therapy due to hematological disease. None of the patients developed antiHCV antibodies. Phylogenetic analysis performed in individual genes
Journal of Hepatology 2017 vol. 66 | S333–S542
follow-up groups, we determined SVR for all patients 12 weeks after the end of the treatment (EOT). Results: All patients (100%) achieved SVR at 12 weeks after the EOT. Virological and functional outcomes of the patients are shown in Table 1. AST and ALT levels, and APRI and FIB-4 scores decreased significantly during treatment ( p < 0.001) in the active follow-up group.
Conclusions: Antiviral treatment with SOF/LED enabled elimination of HCV in patients without cirrhosis. Successful treatment was associated with significant improvement of the enzymatic liver function. There was no difference of SVR rate between the active versus passive follow-up groups. Relinquishing active follow-up during treatment may be an option for patients without cirrhosis. This can increase access to HCV cure in a country like Mongolia, where costs for diagnostics are at a similar level as treatment. FRI-208 Rapid liver fibrosis regression after sustained virological response in HCV patients treated with direct acting antivirals G.M. Lledó Ibáñez1, A. Arias1, L.M. Benítez-Gutiérrez1, M.J. Cítores2 on behalf of Health Research Institute, I. Carrasco2 on behalf of Health Research Institute, V. Cuervas-Mons1, C. De Mendoza2 on behalf of Health Research Institute. 1Internal Medicine; 2Health Research Institute, Hospital Puerta de Hierro, Madrid, Spain E-mail: [email protected] Background and Aims: Treatment with Direct Antiviral Drugs (DAA) results in HCV eradication in more than 90% of treated individuals. HCV clearance had been associated with improved liver function and hepatic fibrosis using interferon-based regimens. Herein, we report outcomes in hepatic fibrosis following SVR12 using DAA therapy. Methods: All HCV-infected patients treated with DAA at a reference clinic in Madrid were examined. Transient elastometry (FibroScan) was performed at baseline and after 12 weeks of completion of therapy, at the time of assessing sustained virological response (SVR12). Liver fibrosis regression was defined as a shift from advanced fibrosis (Metavir F3-F4 {>9.5 KPa}) to null-mild fibrosis (F0-F2) and/or reduction >2 KPa from any baseline value. As reference, APRI and FIB-4 scores were similarly calculated at these time points. Results: A total of 175 patients were treated with DAA and achieved SVR12. Overall, 97 (55.7%) were naïve for HCV therapy, 29% were liver transplant recipients and 36% were coinfected with HIV. At baseline 61.3% had significant liver fibrosis (F3-F4) with a median FibroScan of 17.9 KPa. In this group, FIB4 and APRI scores were 4.8 and 1.8; respectively. At the time of SVR12, a mean reduction of 3.7 KPa ( p = 0,001) was found, along with a drop to FIB4 1.5 ( p = 0.029) and APRI 0.99 ( p = 0.012). Greater improvements were seen in patients with significant liver fibrosis at baseline (F3-F4), with a mean drop of 5.6 KPa (FibroScan), to 2.1 (FIB4) and to 1.4 (APRI) ( p < 0.01 in all cases). Globally, ≥1 grade in Metavir score was noticed in 36.4% of individuals.
Journal of Hepatology 2017 vol. 66 | S333–S542
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POSTER PRESENTATIONS No relationship was found between significant improvements in liver fibrosis and IL28B-CC, baseline serum HCV-RNA, OLT, HIV coinfection, HCV genotype, DAA treatment modality and ribavirin use. Conclusions: Most patients with SVR12 using DAA therapy experience a rapid and significant reduction in liver fibrosis, as assessed using elastometry, FIB4 and/or APRI. A benefit on morbidity and mortality should be expected over time in this population. FRI-209 Platelets represent an independent predictor of sustained virological response (SVR) in patients with advanced chronic hepatitis C (CHC) treated with current direct acting antiviral(s) (DAA). HERACLIS: Hellenic multicenter real-life cohort study G. Papatheodoridis1, A. Kapatais2, E. Sinakos3, I. Elefsiniotis4, J. Goulis3, M. Deutsch5, J. Vlachogiannakos1, G. Dalekos6, J. Koskinas5, S. Karatapanis7, M. Schina8, E. Manesis9, I. Ketikoglou5, V. Sevastianos10, C. Triantos11, E. Cholongitas3, M.-V. Papageorgiou1, A. Kourikou12, T. Karaoulani 2, E. Evangelidou4, A. Koukoufiki3, D. Karagiannakis1, N. Gatselis6, M. Tampaki5, G. Ntetskas7, C. Tsolias11, T. Voulgaris13, P. Ioannidou1, E. Akriviadis3, S. Manolakopoulos1,5. 1 Department of Gastroenterology, National & Kapodistrian University of Athens, Laiko General Hospital, Athens; 2Department of Internal Medicine, General Hospital Nikaia-Piraeus Agios Panteleimon, General Hospital of Western Attica Agia Varvara, Piraeus; 34th Department of Internal Medicine, Hippokratio Hospital, Aristotle University, Thessaloniki; 4University Department of Internal MedicineHepatogastroenterology Unit, General and Oncology Hospital of Kifisia Agioi Anargyroi; 52nd Department of Internal Medicine, National & Kapodistrian University of Athens, Hippokratio General Hospital, Athens; 6 Department of Medicine and Research Laboratory of Internal Medicine, School of Medicine, University of Thessaly, Larissa; 71st Department of Internal Medicine, General Hospital of Rhodes, Rhodes; 83rd Department of Internal Medicine, Evangelismos General Hospital; 9Liver Unit, Euroclinic SA; 104th Department of Internal Medicine and Liver Outpatient Clinic, Evangelismos General Hospital, Athens; 11Department of Gastroenterology, University Hospital of Patras, Patras; 122nd Department of Internal Medicine, National & Kapodistrian University of Athens, Laiko General Hospital; 134th Department of Internal Medicine, Evangelismos General Hospital, Athens, Greece E-mail: [email protected] Background and Aims: DAA have been increasingly used over the last years, since they were shown to be very effective and safe in several phase III trials. However, their efficacy may be lower in patients ( pts) with advanced liver disease treated in routine clinical practice. In the HERACLIS ongoing multicenter cohort study involving most of the Greek tertiary liver centers, we assessed the rates and predictors of SVR in CHC pts treated with currently recommended DAA regimens. Methods: We included all CHC pts who have been treated with DAA regimens recommended by EASL in early 2016. All pts fulfilled the national criteria for treatment reimbursement with DAA [F3 experienced, F4, decompensated cirrhosis (Ci), liver transplantation, severe extrahepatic manifestation]. Efficacy was estimated by SVR12. Results: In total, 604 pts (males: 58%, age: 57 ± 11 years, BMI: 26 ± 4 Kg/m2) were included (GT1a: 11%, GT1b: 35%, GT2: 5%, GT3: 24%, GT4: 24%, GT5: 1%). The severity of liver disease was F0-F2 in 5%, F3 in 21%, F4 in 64% and decompensated Ci in 10% of pts. Most pts (67%) were treatment-experienced [( peg)IFNa ± RBV: 72%, peg-IFNa + RBV + BOC/TPV 15%, SOF based regimens 13%]. SOF + SMV ± RBV, SOF + DCV ± RBV, SOF/LDV ± RBV or 3D ± RBV were given in GT1, SOF + RBV ± pegIFNa or SOF + DCV ± RBV in GT2/3, SOF + RBV ± pegIFNa, SOF + SMV ± RBV, SOF + DCV ± RBV, SOF/LDV ± RBV or 2D + RBV in GT4 and SOF(/LDV) + RBV in GT5 pts. At the time of analysis, SVR12 data were available for 500 (83%) pts. SVR was achieved in 440 (88%) pts and was lower in GT3 (90/119 or 76%) than non-GT3 cases (350/381 or 92%, p < 0.001), in those with decompensated cirrhosis (40/53 or 76%) than with F4 (278/317 or 88%) or F0–3 fibrosis (122/130 or 94%) S502
( p = 0.002) and in patients with platelets (PLT) ≤100 (93/121 or 77%) than >100 × 103/mm3 (347/379 or 92%, p < 0.001). Logistic regression analysis showed that lower SVR rate was independently associated with GT3 (OR: 0.37, 95%CI: 0.17–0.62; p = 0.014) and PLT ≤ 100 × 103 (OR: 0.51, 95%CI: 0.27–0.98; p = 0.043), but not with DAA regimen or therapy duration. Similar findings were observed only in F4 pts, while SVR rates were similar in F4 pts with PLT ≤ 100 × 103 (57/73 or 78%) and pts with decompensated cirrhosis (40/53 or 76%, p = 0.897). Conclusions: In our real-world cohort including mostly treatment experienced CHC pts with advanced liver disease, the efficacy of currently recommended DAA regimens is decreasing in pts with GT3 and/or PLT ≤ 100 × 103/mm3. F4 pts with PLT ≤ 100 × 103/mm3 show similarly low SVR rates with those in pts with decompensated cirrhosis. FRI-210 An outbreak of acute hepatitis C GT1b in onco-hematological patients. Treatment with Sofosbuvir + Ledipasvir and concomitant chemotherapy G. Brancaccio1, M.C. Sorbo2, F. Frigeri3, V. Rizzo4, M. Cantone4, F. Genderini5, L. Fabeni6, A. Pinto3, C.F. Perno6, F. Ceccherini-Silberstein 7, G.B. Gaeta8. 1Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Naples; 2Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy, Tor Vergata, Rome; 3Hematology Department, National Cancer Institute “Fondazione Pascale”, Naples; 4Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Italy; 5Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Naples, Italy; 6Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome; 7Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome; 8Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Rome, Italy E-mail: [email protected] Background and Aims: A short course of antiviral agents has been proven active in acute hepatitis C (AHC) in immunocompetent patients. We report treatment of AHC in patients with oncohematological disease (OHD). Methods: Between January and February 2016, 6 patients with hematological malignances developed marked ALT elevation. AHC was diagnosed by the appearance of serum HCV RNA. All patients received SOF + LDV at standard dose for 8 weeks. Sanger sequencing and phylogenetic analysis of the HCV core/NS3/NS5A/NS5B were performed in 5 patients. Results: All patients (3 males; age 25–57 years) were diagnosed with AHC genotype 1b. OHD were: Peripheral T cell lymphoma; T-cell lymphoblastic lymphoma; Follicular lymphoma; Primary mediastinal diffuse large B cell lymphoma(2); multiple plasmoblastic myeloma; 3 patients had accomplished the chemotherapeutic cycles 4–8 weeks before, 3 patients were on active treatment, that was stopped. Laboratory values were (range): ALT 183–1128 IU/L; GGT 68–1089 IU/L; Total Bilirubin 1.1–11.4 mg/dL; HCV-RNA 2 × 105– 6 × 107 IU/mL; anti-HCV negative. SOF + LDV was started at standard dose. At week 1 ALT values ranged 45–190 IU/L and HCV-RNA was undetectable in 1/6 patients. At week 4, 3 patients were viremic and at week 6 presented HCV-RNA below the limit of detection; in these patients antiviral therapy was extended to 12 weeks. At the end of therapy HCV was undetectable in all patients; at week 4 post-therapy HCV-RNA was undetectable in all; one patient died at week 6 post therapy due to progression of the onco-hematological disease; 5 patients had HCV-RNA undetectable at week 12 post therapy. Three patients re-started chemotherapy* between week 2 and 6 of antiviral treatment. Two additional patients died after week 12 post therapy due to hematological disease. None of the patients developed antiHCV antibodies. Phylogenetic analysis performed in individual genes
Journal of Hepatology 2017 vol. 66 | S333–S542