Although the 2016 Liver Meeting ended a couple of days ago, I am still digesting the more than 2000 presentations. (Random note: One of the digestive disease organizations has a publication called Digest, which I think is the best name ever. There is also a journal titled, Gut which is quite clever too.) Digressing aside (perhaps I should call my blog, Digress…), here are a few more snapshots of presentations from the annual meeting of the American Association for the Study of Liver Diseases. Today I focus on three presentations, all pertaining to the effects of hepatitis C treatment.
Abstract # 2028 Clinically Significant Changes in Heart Rate and Adverse Events Are Not Observed in Clinical Trial Patients Receiving SOF-Based Regimens While on Beta-Blockers - Curtis Cooper, et al.
After Sovaldi was approved, the FDA posted a post-marketing warning stating that cases of serious, symptomatic bradycardia (slow heart rate) in hep C-infected patients taking the cardiac drug amiodarone while being treated with Sovaldi (sofosbuvir)-based regimen. This study investigated changes in heart rate and monitored adverse events in patients treated with sofosbuvir-based regimens and beta-blockers.
This international study analyzed data used in Phase 3 studies used for drug approval. There were 361 subjects on beta blockers and 3,564 subjects who were not. The investigators analyzed various heart disease indicators, including symptoms such as dizziness and syncope.
Conclusion: Comparing the subjects who took beta blockers to those who didn’t, researchers found no trend towards decreased heart rate or increased reporting of cardiac-related signs/symptoms during treatment.
Editorial Comments: My problem with this study is that it needed a control group. Granted, this study shows that people taking beta blockers and regimens using sofosbuvir have comparable experiences to people on regimens using sofosbuvir without beta blockers. However, how do people on regimens using sofosbuvir do compared to people not taking sofosbuvir? Hope we see that research soon.
Abstract #2029 Increase in 10-Year Framingham Cardiovascular Risk Following HCV Eradication With DAA-Based Therapy in HIV/HCV-Coinfected Patients - Teresa Aldámiz-Echevarna, et al.
The Framingham Study is one of the best known studies of all times. This huge ongoing cardiac study began in 1948. A tool that medicine gained from the study is something called the 10-Year Framingham Cardiovascular Risk. There are two calculators, one is lipid-based, the other is body size-based. This HIV/HCV study used the lipid-based calculator.
Previous studies report that people who are chronically infected with hepatitis C virus (HCV) have an increased cardiac injury and death risk. Other studies show that people who are treated and cured (SVR12) have a reduced risk of early morbidity and mortality. This study examined the cardiac risk in 166 HIV/HCV-coinfected patients who achieved SVR; none were taking statins (cholesterol-lowering medicines) at baseline.
Conclusion: After responding to treatment, there were significant increases in cholesterol (total and LDL) which increases the Framingham Cardiovascular Risk.
Editorial Comments: It’s premature to be unsettled about this study’s findings. We know that cholesterol tends to be lower in people with hep C (the liver manufactures cholesterol), and cholesterol increases with successful treatment. Also, we know that cardiac events are increased in people with hepatitis C. We need more long-term data to understand the true risks regarding treatment response and its effects on cardiac risk.
Abstract # 912 Impact of Sustained Virological Response to Direct Acting Antivirals on Insulin Resistance in Patients with Chronic HCV - Mostafa G. Elhelbawy, et al.
People living with chronic hepatitis C virus (HCV) infection are at risk for insulin resistance (IR), which can develop into diabetes. This Egyptian study wanted to know if IR changes after hep C patients are treated and cured (SVR12). This study followed 512 subjects (treatment-naïve and experienced) through treatment prescribed by their physicians. All were treated with direct acting antivirals (DAAs); 80 percent had IR. Nearly 91 percent responded to treatment (SVR12).
Conclusion: Insulin resistance improved significantly in patients who were cured (SVR-12), regardless of which DAA regimens was used.
Editorial Comments: There have been similar studies over the years, with similar results. The stack of evidence showing the benefits of HCV treatment is huge, and now we need to get on to the business of treating everyone.
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