Background and Aim Sorafenib is currently the only approved systemic therapy shown to have efficacy in the treatment of advanced hepatocellular carcinoma (HCC). Recent studies suggest that hepatitis C (HCV)-related HCC patients derive more clinical benefit from sorafenib than other subgroups, but the mechanism for this effect is unknown. In-vitro data suggest that sorafenib may exert antiviral properties and thus our aim in this study, was to evaluate potential antiviral activity of sorafenib in patients with HCV-related HCC. Methods We prospectively enrolled patients with HCV-related HCC treated with sorafenib for up to six months. Baseline clinical, viral, and oncologic data were collected. Patients’ HCV viral loads were obtained at various timepoints, and compared to their baseline viral levels. No patients received any known antiviral therapy during this time. Results Thirty-three patients were identified with baseline and subsequent HCV levels available for analysis. Six patients completed six months of full dose sorafenib, and comparisons of their HCV viral loads showed no significant change at week 24 (difference of means = 0.3500, C.I. = −0.1799 to 0.8799, p = 0.150), or the interim time points. Similarly, the HCV viral loads of all patients who received sorafenib and the viral loads of those patients who had tumor response to sorafenib showed no significant changes at any time point. Conclusion Despite preclinical data and previous subgroup analyses suggesting that sorafenib has antiviral effect against HCV, this study suggests that sorafenib lacks significant anti-viral activity in HCV patients with HCC.

Kroger Specialty Pharmacy provided support in kind pharmacy services for Merck and AbbVie product. The views and statements in this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. Drs. Khalili (K24AA022523) and Sulkowski (K24DA034621) were also partially supported by the National Institutes of Health.

Introduction Although registries can rapidly identify clinical study participants, it is unknown which follow up methods for recruiting are most effective. Our goal is to examine the efficacy of three communication strategies for recruiting and enrolling patients who were identified via a contact registry (i.e., registry linked to a consent to re-contact program). Methods Patients who met the study criteria were identified via the contact registry and targeted for recruitment. In condition 1, patients established in the university hepatology specialty clinics were contacted one time via phone call by the study coordinator and asked to participate (C1). In condition 2, non-established specialty clinic patients were mailed an IRB-approved letter with study information and instructions for calling the study coordinator to participate (C2). Condition 2A included patients who called within two weeks of receiving the letter (C2A); condition 2B included patients who did not call after receiving the letter but were subsequently contacted via phone call. Results A registry identified 1,060 patients, of which 661were eligible and targeted for recruiting. All 37 patients were reached in C1 and 17 (45.9%) were recruited. Nineteen of the 624 patients in C2A were reached and 10 were recruited whereas 120 of the 605 patients in C2B were reached and 53 (8.7%) were recruited. Seventy patients enrolled with C2B being the most effective (total, cost) recruitment strategy (n = 50) (p < .001). Conclusion The efficacy of enrolling patients identified via a contact registry into clinical trials varies based on the communication strategies used for recruiting.

AIMS:Sofosbuvir is a potent hepatitis C Virus (HCV) NS5B RNA polymerase inhibitor that has led to high-sustained viral response rates when combined with other direct-acting antivirals. To date, no data exists on the combination of sofosbuvir with the NS3 protease inhibitor, telaprevir. The safety, tolerability, and efficacy of an all-oral 12-week regimen of telaprevir in combination with sofosbuvir were evaluated in this open-label, phase 2 study. METHODS: Twenty adults with HCV genotype 1 infection who were non-cirrhotic and naïve to therapy received telaprevir 1125 mg orally twice-daily plus sofosbuvir 400 mg once daily for 12 weeks. RESULTS: Telaprevir plus sofosbuvir was generally well tolerated, with all 20 subjects completing treatment. The five most common adverse events were nausea, rash, headache, ano-rectal symptoms, and pruritus. Two subjects required discontinuation of telaprevir after week 4 but were maintained on sofosbuvir till the end of treatment. Sustained virologic response 12 weeks after the end of treatment was 95%. CONCLUSION:The results provide valuable information regarding the safety, tolerability and efficacy of telaprevir combined with sofosbuvir as dual therapy in naïve non-cirrhotic HCV genotype 1 infected patients.

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http://aasldpubs.onlinelibrary.wiley.com/hub/journal/10.1002/(ISSN)2046-2484/video/13-6-reading-horne a video presentation of this article http://aasldpubs.onlinelibrary.wiley.com/hub/journal/10.1002/(ISSN)2046-2484/video/13-6-interview-horne the interview with the author

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