Although direct acting antivirals (DAAs) have revolutionized the treatment of hepatitis C virus (HCV), a small fraction of patients still experience treatment failure. In an editorial in a special issue of the journal Viruses, Che Colpitts, PhD, and Thomas Baumert, MD, of the Institute of Research of Viral Maladies in Strasbourg, France, describe why the research included is important to the future of treating HCV.
“In the USA, chronic hepatitis C infection, the most common cause of liver-related death and liver transplantation, recently surpassed human immunodeficiency virus (HIV) infection as a cause of mortality,” say the authors in the introduction. Patients who do not reach sustained virological response (SVR) are more likely to have a resistant variant. The class of DAA, the genotype of HCV, and the patient group are all factors in the mechanisms of resistance.
The authors point out that, “given that the outcome of DAA-based therapies may be affected by the selection of resistant variants, virological tools to monitor drug resistance both in the drug development stage as well as in the clinic are of critical importance.” There are some diagnostic tools which monitor HCV-resistance, and resistance does not necessarily mean treatment cannot be successful.
In many cases, the latest treatments for hepatitis C virus (HCV) infection are at least 90% effective at curing the infection; however, there still remains a subset of patients who don’t respond to the new medications. Led by researchers in Germany, a study was conducted to see how ribonucleic acid (RNA) assessment can be used to predict outcomes before the end of treatment.
Therapy options for hepatitis C now include sofosbuvir (SOF), ribavirin (RBV), pegylated-interferon-alfa (PegIFN), simeprevir (SMV), and daclatasvir (DCV). The research team studied 298 patients with hepatitis C, genotypes 1 to 5, treated with the following medication combinations:
99 patients: SOF/RBV for 12 or 24 weeks
79 patients: SOF/DCV with or without RBV for 12 or 24 weeks
69 patients: SOF/SMV with or without RBV for 12 weeks
The University of Minnesota is suing Gilead Sciences Inc., alleging the pharmaceuticals company’s lucrative Hepatitis C drugs infringe on a university patent.
In a lawsuit filed in Minnesota’s U.S. District Court Monday, the university claimed its intellectual property covers Gilead products that contain the drug sofosbuvir, including those sold under the brand names Sovaldi and Harvoni. Those Hepatitis C treatments have generated more than $20 billion in revenue for Foster City, Calif.-based Gilead.
The state university system said it brought its patent concerns to Gilead (Nasdaq: GILD) in August 2015, but the company continued its alleged infringement.
Trinity Health and its hospital in Minot have agreed in principal on a legal settlement with 21 victims of the largest hepatitis C outbreak in recent U.S. history
BISMARCK, N.D. (AP) — Trinity Health and its hospital in Minot have agreed in principal on a legal settlement with 21 victims of the largest hepatitis C outbreak in recent U.S. history, though Trinity’s legal fight with a nursing home where most people were sickened will continue.
Trinity attorneys filed a request asking state Judge Todd Cresap to dismiss the lawsuit, saying Trinity recently reached a confidential settlement resolving the plaintiffs’ claims. They asked Cresap to allow a connected legal dispute between the hospital and the former ManorCare nursing home to be resolved in federal court, where it originated. Cresap has not yet ruled.
The study sought to understand the effects of treatment with sofosbuvir-containing therapies on people requiring hemodialysis. Hemodialysis is a process of filtering the blood of a person when the kidneys are not working normally. This was a prospective study. Patients received sofosbuvir once daily (7 patients) or 3 times a week (5 patients) after hemodialysis treatment. Sofosbuvir was given with either simeprevir, daclatasvir, ledipasvir or ribavirin.
It was found that all of the patients tolerated the medications. Two relapses occurred in the 3 times a week group but no one relapse in the daily group.
It was found that sofosbuvir could be safely administered but that close monitoring should be given to hemodialysis patients. They also noted that more data is needed to safely and effectively treat hemodialysis patients.
HCV liver disease progression can increase the risk of severe kidney disease progression. It is important to have effective therapies to treat hepatitis C that are safe for people with severe kidney disease. In clinical trials, Zepatier was shown to be safe and effective in people with kidney disease and hepatitis C. Until more clinical studies are conducted on sofosbuvir containing therapies, Zepatier is a safe alternative to sofosbuvir containing therapies for people on hemodialysis.
Studies on the aged population infected with the hepatitis C virus are lacking. The current study estimated the number of life years and quality-adjusted life years (disease burden, medical burden, future medical intervention) gained with the treatment of Harvoni (sofosbuvir plus ledipasvir) in treatment naïve patients. The data was extracted from published studies and expert opinion. The Markov model was used to estimate HCV disease progression toward advanced liver disease. The Markov model is a standardized model that estimates a possible eventual outcome (long-term disease outcome) based on predetermined factors (current disease state, cure).
The Markov model predicted that life years and the quality adjusted life years “gradually decreased with advancing age but the rate of decline was slower with more advanced fibrosis stage.” In those with F1, F2, F3 life years gained was below 6 months if treated by 55, 65 or 70 years old. The authors concluded that “the quality of life years gained for treated over untreated elderly were reasonably high even for those treated at early fibrosis state.” The authors also concluded that there is significant life expectancy benefit to HCV treatment in pateints up to age 75 with advanced stage fibrosis.”
There is a significant life expectancy and monetary benefit to HCV treatment in patients up to age 75 with advanced-stage fibrosis. HCV treatment is now easier to tolerate and the cure rates are very high. We should be testing every ‘Baby Boomer’ (and perhaps those even born 5 to 10 years earlier than ‘Baby Boomers’) and those at-risk for hepatitis C and treating everyone infected with hepatitis C. This would decrease the disease progression, the medical burden and importantly increase the quality of life for everyone with hepatitis C including those who are up to and beyond age 75 year old.
Scientists have discovered three existing drugs — used for cancer, hepatitis C and for parasitic infections — that they say appear promising against the Zika virus.
The experiments were conducted only in lab-grown human cells in petri dishes, but the results were dramatic. Zika is so devastating that the damage it does has been thought to be irreversible. But the researchers said some of the compounds that the group tested not only allowed cells to live longer in the face of infection — but also in some cases fully recover from them.
The news, reported in Nature Medicine on Monday, is exciting but only a very preliminary step toward a treatment. The researchers will have to test the drugs in animal models to see if they can replicate the results, and if these tests are successful, they will have to start the long process of trying to test the drugs’ effectiveness in humans.
Despite increasing use of antiretrovirals, no reduction in end-stage liver disease risk was observed among patients coinfected with HIV and viral hepatitis during a 15-year period, according to an analysis of data from The North American AIDS Cohort Collaboration on Research and Design.
“Patients triply infected with HIV, hepatitis C virus and hepatitis B virus were at particularly high risk, having a 12-fold higher incidence rate of [end-stage liver disease (ESLD)] compared with HIV monoinfected patients, even in the modern ART era,” Marina B. Klein, MD, MSc,FRCPC, professor in the division of infectious diseases at McGill University, and colleagues wrote. “Even after accounting for competing risks of death, CD4 and HIV RNA suppression, we observed no apparent improvement in ESLD rates in our HIV/HCV coinfected population.”
Although patients with HIV who are coinfected with HBV or HCV are at increased risk for ESLD, whether use of modern ART reduced that risk was unknown.