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The "HCV Advisor" APP - A Web-Based Mobile Application to Identify Suitable Treatments with Direct Antiviral Agents for Chronic Hepatitis C Infection
males, 64% Caucasians, with a median age of 59 years (range: 36-75). All patients were diagnosed with cirrhosis, 18% were decompensated, 42% were treatment experienced, and 70% were genotype 1a. The majority of patients (92%) received Ledipasvir/Sofosbuvir (LDV/ SOF) and 38% were treated for 24 weeks. Of 93 patients one patient (treatment experienced with decompensated cirrhosis) developed HCC 639 days from the treatment start date and received 24 weeks of treatment with LDV/SOF. Conclusion. This is a small size study reporting early observation of HCC risk reduction in patients with liver cirrhosis treated with DAAs to 1% per year. Larger studies with longer duration of follow up are needed to validate our findings.
Sa1539
Objectives: Evaluate outcomes of ledipasvir-sofosbuvir (Harvoni) based hepatitis C therapy in non-transplant patients at a diverse, urban, tertiary center clinical setting. Methods: All patients treated with ledipasvir-sofosbuvir therapy between October 2014 and October 2015 were evaluated for efficacy of therapy. Background information including age, gender, race, BMI, degree of fibrosis and prior hepatitis C treatment history were collected. Response to treatment was measured using HCV RNA levels during treatment at weeks 0, 4, 12 and end of treatment. Sustained viral response (SVR) was evaluated at weeks 4 (SVR4) and 12 (SVR12) after treatment. Pretreatment and posttreatment liver enzymes, peak total bilirubin, HCV genotype, initial laboratory parameters, and hemoglobin nadir were collected. Results: 307 patients completed therapy and were at least 12 weeks out from treatment. 187 (67%) were males and 120 were females, mean age was 61 (25-91) and average BMI was 29.0 (15.456.4). 159 (52%) patients were African American, 106 (35%) were Caucasian. 170 (55%) patients had genotype 1a, 96 (31%) patients had genotype 1b. Thirty-four patients had Ishak score greater than 3 or fibroscan score greater than 12.4. 102 (33%) patients had diagnosis of cirrhosis prior to starting treatment. 188 (61%) patients were treatment naïve. 25 (8%) patients were treated for 8 weeks, 215 (70%) were treated for 12 weeks, and 66 (22%) patients were treated for 24 weeks. After completion of treatment, 100% of patients achieved initial undetectable viral loads. 25 (100%) of patients requiring only 8 weeks of therapy achieved SVR12. 207 (96%) patients requiring 12 weeks of therapy achieved SVR12. 64 (97%) of patients requiring 24 weeks of therapy achieved SVR12. 182 (97%) treatment naïve patients achieved SVR12, 116 (98%) patients with prior treatment achieved SVR12. 154 (97%) of African Americans achieved SVR 12. 99 (97%) of patients with cirrhosis achieved SVR12. 43 (15%) patients had elevation (>1.5x) in their liver function tests midtreatment. The average drop in hemoglobin for all patients was 1.5 grams/dL (range: -1.6 - 7.4). For patients on ledipasvir-sofosbuvir in combination with ribivarin, average hemoglobin drop was 2.1 grams/dL (range: -0.8 - 5.5). 13 (4%) patients developed hyperbilirubinemia (total bilirubin ≥2.5) during treatment, 8 (62%) of which improved by the end of treatment. All patients with hyperbilirubinemia completed therapy with 12 (92%) achieving SVR12. Discussion In our experience at a diverse urban, tertiary, liver transplant center, combination therapy of ledipasvir-sofosbuvir is well tolerated in the general population. Twelve weeks of therapy with or without ribavirin was adequate for SVR12. ledipasvir-sofosbuvir was 96% effective at achieved SVR12 in our experience.
Sa1537 THE "HCV ADVISOR" APP - A WEB-BASED MOBILE APPLICATION TO IDENTIFY SUITABLE TREATMENTS WITH DIRECT ANTIVIRAL AGENTS FOR CHRONIC HEPATITIS C INFECTION Heiko Fruehauf, Nils Knobloch, Sven Knobloch, David Semela, Stephan Vavricka Background: With the rapid development of new direct antiviral agents (DAA) for the management of chronic hepatitis C and their complex combinations depending on individual viral and host baseline factors as well as health care policy limitations, it is challenging for practitioners to quickly access up-to-date treatment recommendations during clinical decision making. Aims: To develop a clinical decision-oriented, user-friendly and free smartphone application (the "HCV Advisor" App) to help clinicians adequately select a specific DAA regimen according to viral characteristics and host parameters in accordance with national guidelines, drug approval status and reimbursement policy as well as recognition of potential interactions and side effects, that runs on web browsers, mobile platforms (iOS, Android) and desktops. Methods: App development was separated into development of the user interface and the selection algorithms (using the Ionic Framework), and the development of a SQL-Database, which can be easily modified by non-IT-specialists. After entering viral load and genotype, known NS5a polymorphisms, presence of extrahepatic manifestations, degree of fibrosis, response to a previous interferon-based therapy, patients weight and optional input such as concomittant drug therapy or renal function, the user receives a list of suitable DAA regimens (dose, duration, expected individual response rate based on phase3-studies, side effects, possible interactions, approval and reimbursement status) including country specific pricing. The "HCV Advisor" App was reviewed by the authors of the national guideline and beta tested by members of the Swiss hepatology (SASL) and infectiology societies (SSID). Results: The "HCV Advisor" App adequately reflects treatment recommendations provided by the national guideline in individual patients and provides additional information on drug interactions and an appointment calculator. It is available in Switzerland in both the App Store and Google Play Store without charge, and has the capability to use other country- or society-specific databases. Users rated access to treatment information via the "HCV Advisor" App faster, more specific and detailed compared to web published guidelines. Conclusions: Web-based mobile applications are superior to conventional publications due to easy access, allowing individual "shared decision making". Modern communication technologies such as the HCV Advisor App support clinical practitioners to adequately select suitable treatment regimens and national societies to provide up-to-date recommendations for the management of chronic hepatitis C infection.
Sa1538 HEPATITIS C TREATMENT IN CIRRHOTICS: IS THE RISK OF HEPATOCELLULAR CARCINOMA REDUCED WITH THE NEW DIRECT ANTIVIRAL AGENTS? Mohamed G. Shoreibah, Krishna V. Venkata, DeAnn Jones, Jordan Orr, Jenine Zaibaq, Omar Massoud Background and aim. The risk of hepatocellular carcinoma (HCC) in patients with cirrhosis secondary to hepatitis C virus (HCV) infection is 2-6% per year. The use of interferon (IFN) for HCV treatment has been associated with a decreased risk of HCC. Data regarding the potential benefit of HCC risk reduction with the use of the new direct antiviral agents (DAA) is scant. The aim of the study was to examine the incidence of HCC in patients with liver cirrhosis secondary to HCV infection who were treated with IFN free DAA regimens. Methods. This is a retrospective study of 94 patients with liver cirrhosis secondary to HCV who were treated with DAAs between 2014 and 2016. Patients included in study achieved sustained viral response and were followed for at least one year from treatment start date. One patient developed HCC within 6 months of treatment end date and was excluded from the study. The median time to follow up was 488 days (range: 366-863). Results. Patients were 52%
Table 1. Treatment Efficacy
S-1101
AASLD Abstracts
AASLD Abstracts
LEDIPASVIR-SOFOSBUVIR FOR HEPATITIS C VIRUS INFECTION IN A DIVERSE URBAN SETTING HAS HIGH EFFICACY REGARDLESS OF TREATMENT EXPERIENCE AND STAGE OF FIBROSIS Patrick R. Brown, Omar Sadiq, Alexander Weick, Adrienne Lenhart, Mohammad Elbatta, William J. Kane, Christopher Fernandez, Mohammad Arsalan Siddiqui, Anas Kutait, Robert Pompa, Syed-Mohammed Jafri
Sa1539
Objectives: Evaluate outcomes of ledipasvir-sofosbuvir (Harvoni) based hepatitis C therapy in non-transplant patients at a diverse, urban, tertiary center clinical setting. Methods: All patients treated with ledipasvir-sofosbuvir therapy between October 2014 and October 2015 were evaluated for efficacy of therapy. Background information including age, gender, race, BMI, degree of fibrosis and prior hepatitis C treatment history were collected. Response to treatment was measured using HCV RNA levels during treatment at weeks 0, 4, 12 and end of treatment. Sustained viral response (SVR) was evaluated at weeks 4 (SVR4) and 12 (SVR12) after treatment. Pretreatment and posttreatment liver enzymes, peak total bilirubin, HCV genotype, initial laboratory parameters, and hemoglobin nadir were collected. Results: 307 patients completed therapy and were at least 12 weeks out from treatment. 187 (67%) were males and 120 were females, mean age was 61 (25-91) and average BMI was 29.0 (15.456.4). 159 (52%) patients were African American, 106 (35%) were Caucasian. 170 (55%) patients had genotype 1a, 96 (31%) patients had genotype 1b. Thirty-four patients had Ishak score greater than 3 or fibroscan score greater than 12.4. 102 (33%) patients had diagnosis of cirrhosis prior to starting treatment. 188 (61%) patients were treatment naïve. 25 (8%) patients were treated for 8 weeks, 215 (70%) were treated for 12 weeks, and 66 (22%) patients were treated for 24 weeks. After completion of treatment, 100% of patients achieved initial undetectable viral loads. 25 (100%) of patients requiring only 8 weeks of therapy achieved SVR12. 207 (96%) patients requiring 12 weeks of therapy achieved SVR12. 64 (97%) of patients requiring 24 weeks of therapy achieved SVR12. 182 (97%) treatment naïve patients achieved SVR12, 116 (98%) patients with prior treatment achieved SVR12. 154 (97%) of African Americans achieved SVR 12. 99 (97%) of patients with cirrhosis achieved SVR12. 43 (15%) patients had elevation (>1.5x) in their liver function tests midtreatment. The average drop in hemoglobin for all patients was 1.5 grams/dL (range: -1.6 - 7.4). For patients on ledipasvir-sofosbuvir in combination with ribivarin, average hemoglobin drop was 2.1 grams/dL (range: -0.8 - 5.5). 13 (4%) patients developed hyperbilirubinemia (total bilirubin ≥2.5) during treatment, 8 (62%) of which improved by the end of treatment. All patients with hyperbilirubinemia completed therapy with 12 (92%) achieving SVR12. Discussion In our experience at a diverse urban, tertiary, liver transplant center, combination therapy of ledipasvir-sofosbuvir is well tolerated in the general population. Twelve weeks of therapy with or without ribavirin was adequate for SVR12. ledipasvir-sofosbuvir was 96% effective at achieved SVR12 in our experience.
Sa1537 THE "HCV ADVISOR" APP - A WEB-BASED MOBILE APPLICATION TO IDENTIFY SUITABLE TREATMENTS WITH DIRECT ANTIVIRAL AGENTS FOR CHRONIC HEPATITIS C INFECTION Heiko Fruehauf, Nils Knobloch, Sven Knobloch, David Semela, Stephan Vavricka Background: With the rapid development of new direct antiviral agents (DAA) for the management of chronic hepatitis C and their complex combinations depending on individual viral and host baseline factors as well as health care policy limitations, it is challenging for practitioners to quickly access up-to-date treatment recommendations during clinical decision making. Aims: To develop a clinical decision-oriented, user-friendly and free smartphone application (the "HCV Advisor" App) to help clinicians adequately select a specific DAA regimen according to viral characteristics and host parameters in accordance with national guidelines, drug approval status and reimbursement policy as well as recognition of potential interactions and side effects, that runs on web browsers, mobile platforms (iOS, Android) and desktops. Methods: App development was separated into development of the user interface and the selection algorithms (using the Ionic Framework), and the development of a SQL-Database, which can be easily modified by non-IT-specialists. After entering viral load and genotype, known NS5a polymorphisms, presence of extrahepatic manifestations, degree of fibrosis, response to a previous interferon-based therapy, patients weight and optional input such as concomittant drug therapy or renal function, the user receives a list of suitable DAA regimens (dose, duration, expected individual response rate based on phase3-studies, side effects, possible interactions, approval and reimbursement status) including country specific pricing. The "HCV Advisor" App was reviewed by the authors of the national guideline and beta tested by members of the Swiss hepatology (SASL) and infectiology societies (SSID). Results: The "HCV Advisor" App adequately reflects treatment recommendations provided by the national guideline in individual patients and provides additional information on drug interactions and an appointment calculator. It is available in Switzerland in both the App Store and Google Play Store without charge, and has the capability to use other country- or society-specific databases. Users rated access to treatment information via the "HCV Advisor" App faster, more specific and detailed compared to web published guidelines. Conclusions: Web-based mobile applications are superior to conventional publications due to easy access, allowing individual "shared decision making". Modern communication technologies such as the HCV Advisor App support clinical practitioners to adequately select suitable treatment regimens and national societies to provide up-to-date recommendations for the management of chronic hepatitis C infection.
Sa1538 HEPATITIS C TREATMENT IN CIRRHOTICS: IS THE RISK OF HEPATOCELLULAR CARCINOMA REDUCED WITH THE NEW DIRECT ANTIVIRAL AGENTS? Mohamed G. Shoreibah, Krishna V. Venkata, DeAnn Jones, Jordan Orr, Jenine Zaibaq, Omar Massoud Background and aim. The risk of hepatocellular carcinoma (HCC) in patients with cirrhosis secondary to hepatitis C virus (HCV) infection is 2-6% per year. The use of interferon (IFN) for HCV treatment has been associated with a decreased risk of HCC. Data regarding the potential benefit of HCC risk reduction with the use of the new direct antiviral agents (DAA) is scant. The aim of the study was to examine the incidence of HCC in patients with liver cirrhosis secondary to HCV infection who were treated with IFN free DAA regimens. Methods. This is a retrospective study of 94 patients with liver cirrhosis secondary to HCV who were treated with DAAs between 2014 and 2016. Patients included in study achieved sustained viral response and were followed for at least one year from treatment start date. One patient developed HCC within 6 months of treatment end date and was excluded from the study. The median time to follow up was 488 days (range: 366-863). Results. Patients were 52%
Table 1. Treatment Efficacy
S-1101
AASLD Abstracts
AASLD Abstracts
LEDIPASVIR-SOFOSBUVIR FOR HEPATITIS C VIRUS INFECTION IN A DIVERSE URBAN SETTING HAS HIGH EFFICACY REGARDLESS OF TREATMENT EXPERIENCE AND STAGE OF FIBROSIS Patrick R. Brown, Omar Sadiq, Alexander Weick, Adrienne Lenhart, Mohammad Elbatta, William J. Kane, Christopher Fernandez, Mohammad Arsalan Siddiqui, Anas Kutait, Robert Pompa, Syed-Mohammed Jafri