Source: Abstract #THU-457 Favourable virological and clinical outcomes at 1 year after liver transplantation in hepatitis C virus-positive patients who received direct-acting antivirals on the waiting list-S. Martini, et al.
Study Aims and Results: The return of hepatitis C is very common for people who are viremic when receiving a liver transplant. Significant liver stiffness was highly linked with the transplantation failure one year post treatment. This study looked at what effects treatment of hepatitis C with direct acting antivirals (DAAs) pre-transplant had on health outcomes 1 year after transplantation. From July 2014 and October 2016 there were 64 hepatitis C positive people treated with direct acting antivirals + ribavirin while on the wait list who underwent a transplantation. Of those, 16 participants made the transition from pre-to post-transplant and remained hepatitis C negative. The median age of recipients was 57 years old; 84% were male. The median donor was 66 years old. The amount of time participants who were hepatitis C negative prior to liver transplant was 94 days. Of the 55 participants who reached SVR12 post-transplant, 54 of them were hepatitis C negative. The median number of days for follow up post-transplant was 377.
Conclusion: This study was able to show that using DAAs pre-, and close to, transplantation resulted in 98% of the participants being hepatitis C negative. Treating before transplant also led to fewer post-transplantation liver complications and rejections. Even though many of the transplantation donors were elderly, 75% of the participants showed absent/mild liver scarring 1 year after transplantation.
Editorial Comments: Liver transplantation is expensive, scary and comes with a risk of failure. This study showed that curing someone of hepatitis C before they receive a transplant can significantly reduce the poor outcomes that have been shown among those who don’t receive similar treatment. Being able to reduce liver scarring and the risk of transplant being rejected is encouraging. This gives hope to those seeking a transplant and confidence for all involved that it will work and they can remain cured.
Source: Abstract #THU-439 interferon-free therapy is effective and safe for hepatitis C recurrence in liver transplant hepatitis C virus/human immunodeficiency virus coinfected recipients: a case-control study- M.-C. Londoño, et al.
Study Aims and Results: Current studies show interferon-free treatments are successful and safe for monoinfected liver transplant recipients with hepatitis C. There are fewer examples looking at how successful direct acting antivirals are in HCV/HIV co-infected liver transplant recipients. This study focused on looking at the success and side effects of interferon-free treatment in a national cohort of HCV/HIV coinfected participants who had HCV return after transplantation. There were 38 HCV/HIV-coinfected and 133 HCV monoinfected liver transplant participants enrolled in the study. The two groups were fairly similar in gender, age, genotype, viral load, fibrosis stage and the amount of time from transplantation to treatment at 38 and 47 months. All coinfected participants were on HIV treatment; 84% had a RNA viral load of less than 50 copies/ml (undetectable) and a median white blood cell count of 367 cells/uL. For comparison, 1100-1400 white blood cells/ul is the range of someone who is not immunocompromised. The top three direct acting antiviral treatments that were used are as follows: ledipasvir + sofosbuvir ± ribavirin (RBV) (33%), simeprevir+ sofosbuvir ± RBV (31%), daclatasvir + sofosbuvir ± RBV (28%), simeprevir+daclatasvir ± RBV (5%), and AbbVie’s 3D (3%). More than half of each cohort received RBV. The treatment success was also close among the cohorts, with 92% of the coinfected group having a sustained virologic response 12 weeks post treatment (cure), and 96% of the monoinfected group. There were no serious side effects of treatment or differences in success related to genotype and advanced fibrosis.
Conclusion: This study was able to show interferon-free treatments for HIV-positive people who have had hepatitis C return are successful with few side effects. As important, this study showed that the success rates of interferon-free treatment were similar to hepatitis C monoinfected participants.
Editorial Comments: Tackling the issue of treatment for people who receive a liver transplant and have hepatitis C return is crucial to any elimination plan. This is important not only among monoinfected people but those who are coinfected with compromised immune systems. The closer we can get to a treatment that is effective on both cohorts and has fewer side effects, the more likely we are to eliminate hepatitis C and save lives. Most importantly, this study shows that even after liver transplants people can be treated.
Source: Abstract #SAT-201 Gender differences on long-term outcomes in patients with dual chronic hepatitis B virus (HBV) and chronic hepatitis C virus (HCV) infection—S. Shah, et al.
Study Aims and Results: Male gender is a proven risk factor among those with chronic mono HCV infection to develop end-stage liver disease and liver cancer (hepatocellular carcinoma or HCC). What is unclear is if any gender differences persistently exist among patients with dual HBV/HCV infection. This study investigated the occurrence of cirrhosis, hepatic decompensation and HCC in HBV/HCV dual infected individuals. 239 men and 120 women with HBV/HCV infection that were seen from 1999 through 2015 at U.S. tertiary care centers were evaluated for this study. Subject’s medical records yielded laboratory values, imaging results and necessary treatment information. The main outcomes were the 10-year occurrence of cirrhosis, hepatic decompensation and HCC. The demographic breakdown is as follows: 41% White, 31% Asian, 15% Hispanic and 13% identified as Other. The mean age was 55.2 with a plus or minus of 10.9 years among men and 56.8 with a plus or minus of 13.1 among women. There was no baseline gender difference in HCV viral load or level of liver scarring, however, men did have higher rates of alcohol and tobacco use, as well as diabetes, lower number of blood clotting agents and were more likely to present with HCC than women. The 10-year occurrence of cirrhosis in individuals without baseline cirrhosis was high yet similar across genders. Despite this, men were significantly more likely to develop HCC. The occurrence of HCC in men and women was 101.6 (men) and 57.8 (women) per 1,000 person years. This means that 101.6 and 57.8 cases would be expected in a given year among HBV/HCV dual infected people. The 10-year total HCC occurrence was 37% among men and 17% among women. Men also showed a higher total trend of a 10-year occurrence in hepatic decompensation than women.
Conclusion: The occurrence of cirrhosis and HCC was high in both men and women with HBV/HCV dual infection. Still, men showed a significantly higher risk for HCC. There also were no gender differences in the occurrence of cirrhosis development.
Editorial Comments: This study showed the importance of early antiviral therapy among HBV/HCV dual infected individuals. An approach of early treatment intervention among this group will help prevent long-term complications. A focus on those who are at a higher risk is especially important. Testing for HBV upon HCV diagnosis is key to this approach as well. This study shows the potentially negative outcomes of failing to address HBV/HCV dual infection among both men and women while underscoring the significant risk posed to men who go untreated.
Source: Abstract #SAT-206 Field evaluation of Xpert® HCV Viral Load point-of-care test for detection of hepatitis C virus infection by venipuncture-collected and finger-stick capillary whole-blood samples—J. Grebely, et al.
Study Aims and Results: Improving HCV testing, diagnosis and linkage to care is a continuing challenge. Current point-of-care testing allows for easy and quick delivery of HCV antibody results. Developing a similar HCV RNA point-of-care test will allow for the diagnosis of active infection at the same time. This study evaluates the Xpert® HCV Viral Load assay using samples collected by venipuncture and finger stick capillary whole-blood. The needed samples were collected from people in a study where they were observed receiving services in Australia. Xpert® HCV Viral Load assay’s reliability and accuracy was compared to the current “gold standard”, Abbott Real Time HCV Viral Load assay. There were 150 participants in the study. The median age was 44 years, 87% were male and 65% reported a history of injection drug use. There were 45 HCV RNA positive people. The reliability and accuracy of the Xpert® HCV Viral Load assay for HCV RNA detection in blood draw samples was 100% and 99.1%. In the one instance where the Abbott Real Time HCV RNA was undetectable and the Xpert® HCV RNA was detectable HCV RNA was confirmed with a RT-PCR HCV RNA assay. This confirmation determined the Xpert® was false positive. The reliability and accuracy of the Xpert assay for HCV RNA detection in finger stick samples was 95.5% and 98.1%.
Conclusion: The study showed that the Xpert® HCV Viral Load assay had comparatively reliable results to the Abbott Real Time HCV RNA Viral Load assay in terms of reliability and accuracy
Editorial Comments: The reliability of the Xpert® HCV Viral Load assay when compared to the Abbott Real Time HCV RNA Viral Load assay is promising. The inability to provide on-site HCV RNA confirmation for the existing OraQuick HCV Antibody point-of-care test has shown to be unable to improve the HCV Treatment Cascade issues of client confirmation. Providing an HCV antibody result is important but if we are unable to confirm active infection providing a positive antibody assay runs the potential of increasing anxiety without providing concrete answers. The Xpert® HCV Viral Load assay looks to be a promising step towards improving that.
Abstract # FRI-454 The evaluation of homelessness on HCV treatment outcomes among current and former people who inject—A. Singh et al. By Matthew Zielske
Study Aims and Results: This study focuses on figuring out the impact homelessness has on HCV + people who inject drugs successfully reaching and maintaining SVR among. The location of this study was the Vancouver Infectious Diseases Center (VIDC) program, which provides care to address medical, psychological, social and addiction related needs. Homelessness was self-declared, Patients were followed up with every 6 months after SVR and more frequently if reinfection was believed to be a concern. In situations where reinfection happened treatment was also considered a failure.
Conclusion: Of the 74 people who participated in the study, 58% of them were homeless and 88% of those homeless reached SVR. In comparison, 97% of those with stable housing reached SVR. The two occurrences of reinfection were among people who identified as homeless.
Editorial Comments: This study is promising because of its focus on the role of homelessness both reinfection and successfully reaching SVR. I recently worked with someone who was living under a bridge and keeping his Harvoni in a backpack and successfully reached SVR. But the challenges are numerous and this study shows that even while being homeless 88% can reach and maintain SVR. This is a remarkable achievement in some of the most challenging conditions.
Abstract # THU-225 Four weeks of Ledipasvir/Sofosbuvir + Ribavirin with or without pegylated interferon gives very high and sustained cure rates in difficult to reach but easy to treat injecting drug users with chronic hepatitis C: final results of the 4WIDUC study— A.L.H. Oevrehus et al. by Matthew Zielske
Study Aims and Results: Researchers in this study looked at sustained virologic response (SVR) outcomes of treatment naïve patients on opioid substitution therapy (OST) 12 and 24 weeks after a 4-week treatment cycle. There was an equal number of patients who received Harvoni + Ribavirin with and without interferon. Harvoni is only approved to treat genotypes 1,4, 5 and 6.
Although people with any genotype could be considered for this study, only those who were treatment naïve, on OST, under the age of 50, weighed less than 220lbs and had a viral load under 2 million IU/ml were accepted.
Conclusion: Over the course of a year 32 of 48 people screened began treatment. Of those 32 people, 6 failed to move further into the study because of a high viral load. In the SVR 12 group all but one person with genotype 2 reached SVR. Among those in the SVR 24 population 92% reached SVR when interferon was included and 69% reached SVR when interferon wasn’t included. Causes for failure among those in the SVR 24 group were early relapse, probably reinfection/late relapse, treatment unrelated suicide and dropout before end of treatment.
Editorial Comments: This was a very interesting look at the potential for shortened treatment. Although the number of participants was small, the results of reaching SVR when incorporating pegylated interferon seem to indicate a distinct difference in treatment success. More research needs to be done with a larger group of people, but this is a promising exploration into finding successful ways to treat hard to reach populations. The draw backs to the study are many people do not want to take pegylated interferon and it’s not to be used with people who have mental health issues.
Abstract # THU-238 Feasibility and acceptability of a group medical visit intervention to improve hepatitis C virus treatment uptake among persons who inject drugs (PWID) in a primary care setting—B. Norton et al. by Matthew Zielske
Study Aims and Results: This study focuses on an inventive intervention called, HCV Group Evaluation and Treatment Uptake (HCV GET-UP).
In this study patients were recruited from a primary care clinic in the Bronx, NY. Group visits with a physician took place over the course of four weeks. During the group visits, hep C related health care evaluations, education support and skill building took place. The likelihood of this study being successful was assessed through recruitment, retention rates and acceptability by means of a short post group survey which was laid out as a 5-point Likert scale (not helpful to very helpful).
Phone contact was made with 27 (67.5%) of the 40 people initially eligible. There were 13 (48.1%) people of those 27 who agreed to be screened with seven deciding to enroll. The demographic breakdown is as follows; most were male, all were African American or Latino and their median age was 55. Almost all of them were being treated for opioids and three of them were actively using drugs at their initial visit.
Conclusion: Of the 6 people that initially attended one group visit, 5 attended a follow up HCV treatment appointment and 4 have begun treatment. The average of the survey results was; evaluation: 5, education: 4.8, skill building: 5, group activity or support: 5
Editorial Comments: A meta-analysis review of acute HCV in people with HIV would be helpful. This will narrow down the optimal timeframe to treat. Still, the cure rates are very encouraging! Although the study is promising in its approach to engaging and retaining hepatitis C positive people who inject drugs in healthcare only 4 of the 40 antibody positive patients began treatment. Of the 7 who enrolled this is a great result but more needs to be done to increase the number of those who willingly begin the process. The fact that three people who were actively using drugs were included is also very promising and shows the healthcare model can and is willing to change.