Treatment with an all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without ribavirin (RBV) for 12 weeks resulted in high sustained virologic response (SVR) rates along with minimal adverse events in non-liver transplant (LT) patients with hepatitis C virus (HCV) genotype 1 infection. This is the first multicenter report on the efficacy, safety, and tolerability of this regimen in LT recipients. A total of 123 patients (76% male, 74% white, 60% genotype 1a, 30% METAVIR F3-F4, 4% decompensation, 11% cholestatic recurrence, 7% had kidney transplant, and 82% previously failed pegylated interferon/RBV-based regimens) received treatment and were followed for a median of 30 weeks (range 12-53 weeks). The median time from LT to treatment was 32 months (range 2-317 months). Tacrolimus was the primary immunosuppression in 91% of patients. Minimal immunosuppression dose adjustments were required. An SVR 12 weeks after treatment completion (SVR12) was achieved in 90% of patients (95% confidence interval 84%-96%). In patients with genotype 1a infection, the SVR12 rate was significantly lower in those with METAVIR F3-F4 (71%) compared to those with F0-F2 (91%). Half of the patients achieved undetected HCV RNA at treatment week 4, and their SVR12 rate was significantly higher (96%) compared to those with detectable HCV RNA (83%). Treatment was very well tolerated with mild degrees of adverse events, except for one death possibly due to drug-induced lung injury. In the 25 patients who received RBV, 72% developed anemia requiring intervention. Conclusion: An all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without RBV for 12 weeks was very well tolerated and resulted in excellent SVR12 rates in LT recipients with HCV genotype 1 infection. (HEPATOLOGY 2015;61:1880-1886 H epatitis C viral (HCV) infection is the leading indication for liver transplant (LT) worldwide. Recurrence of HCV is universal among recipients with viremia at the time of transplant and occurs immediately after LT. 1,2 Although the clinical course of HCV recurrence is variable, severe histological recurrence is the most common cause of graft loss and death, which accounts for approximately 60% of graft losses and nearly 50% of deaths by 10 years after LT. 3,4 Liver allograft and recipient survival can be substantially improved with successful eradication of HCV. 5,6 Treatment with pegylated interferon (Peg-IFN) and ribavirin (RBV) was not effective and poorly tolerated in the post-LT setting, with reported sustained virologic response (SVR) rates ranging 24%-45% for patients with HCV genotype 1. 7,8 The combination of direct-acting antiviral agents, in the form of a firstgeneration protease inhibitor (PI), telaprevir or boceprevir, with Peg-IFN and RBV improved SVR rates to
The safety, efficacy, and effect on immunosuppression levels of telaprevir (TVR) or boceprevir (BOC) in combination with peginterferon (PEG-IFN) and ribavirin (RBV) in recipients of liver transplantation (LT) with hepatitis C virus (HCV) genotype 1 have not been defined. We report our 3 centers' preliminary experiences with administering triple antiviral treatment protocols containing PEG-IFN, RBV, and TVR or BOC. Patients with biopsy-proven HCV recurrence (METAVIR grade 3 and/or stage 2) received TVR with PEG-IFN/RBV for 12 weeks and then PEG-IFN/RBV for 36 weeks or BOC with PEG-IFN/RBV for 44 weeks after 4 weeks of lead-in PEG-IFN/RBV. Maintenance immunosuppression was changed to cyclosporine whenever possible, and the levels were followed closely. PEG-IFN/RBV dose adjustments were based on patients' tolerance. Sixty patients started triple antiviral treatment, and they were followed for up to 66 weeks (mean 5 35 weeks); all were followed at least 12 weeks. Thirty of the 35 patients treated with TVR (86%) achieved undetectable HCV RNA levels after an average of 6 weeks, whereas 12 patients (48%) in the BOC-treated group achieved undetectable HCV RNA levels after a mean of 11 weeks. According to an intention-to-treat analysis, 14 of 21 TVR-treated patients (67%) and 10 of 22 patients who received BOC (45%) achieved undetectable HCV RNA levels at week 24 without viral breakthrough at the last follow-up. Cytopenias complicated both regimens; all patients required dose reductions of PEG-IFN and/or RBV or the administration of hematological growth factors. One death occurred in each group on triple antiviral treatment. In conclusion, TVR or BOC combined with PEG-IFN/RBV achieved ontreatment virological response rates of approximately 50% to 60% in patients with recurrent HCV after LT, but significant side effects were common. Liver Transpl 19:690-700, 2013. V C 2013 AASLD.Received November 1, 2012; accepted March 31, 2013. Hepatitis C virus (HCV) infection is the leading indication for liver transplantation (LT) in the UnitedStates.1 HCV recurrence is universal and occurs immediately after LT.2 Although the severity and clinical course of HCV infections after LT are variable, severe histological recurrence is the most common cause of death and graft loss in LT recipients with HCV infections and accounts for approximately half of
ObjectiveThe Institute of Medicine and the draft National Pain Strategy recently called for better training for health care clinicians. This was the first high-level needs assessment for pain psychology services and resources in the United States.DesignProspective, observational, cross-sectional.MethodsBrief surveys were administered online to six stakeholder groups (psychologists/therapists, individuals with chronic pain, pain physicians, primary care physicians/physician assistants, nurse practitioners, and the directors of graduate and postgraduate psychology training programs).Results1,991 responses were received. Results revealed low confidence and low perceived competency to address physical pain among psychologists/therapists, and high levels of interest and need for pain education. We found broad support for pain psychology across stakeholder groups, and global support for a national initiative to increase pain training and competency in U.S. therapists. Among directors of graduate and postgraduate psychology training programs, we found unanimous interest for a no-cost pain psychology curriculum that could be integrated into existing programs. Primary barriers to pain psychology include lack of a system to identify qualified therapists, paucity of therapists with pain training, limited awareness of the psychological treatment modality, and poor insurance coverage.ConclusionsThis report calls for transformation within psychology predoctoral and postdoctoral education and training and psychology continuing education to include and emphasize pain and pain management. A system for certification is needed to facilitate quality control and appropriate reimbursement. There is a need for systems to facilitate identification and access to practicing psychologists and therapists skilled in the treatment of pain.
Collaborative on Countering the US Opioid Epidemic [8] has been focusing on comprehensive and collaborative efforts to fundamentally address the opioid epidemic crisis. All of these major initiatives emphasize pain education as a key component in the fight against the dual crises of chronic pain and the opioid epidemic. I am honored to represent the AAPM on the HHS Pain Management Task Force and the NAM Action Collaborative and contribute to these important initiatives of our nation on your behalf.
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