I HEPATITIS C VIRUS
- About some terms – SVR12 vs. SVR24
- SVR linked to longer survival and other benefits
- Issues with emerging therapies for HCV
- Simeprevir + sofosbuvir – experience in the clinic
- Holkira Pak approved in Canada for genotype 1
- Holkira Pak – results in genotype 1a without severe liver injury
- Holkira Pak – results in genotype 1a with severe liver injury
- Holkira Pak– effectiveness in people with kidney dysfunction
- Holkira Pak– effectiveness in people with liver transplantation
II HIV AND TRANSPLANTATION
- HIV and liver transplants in British Columbia
I HEPATITIS C VIRUS
About some terms – SVR12 vs. SVR24
After a person has successfully completed treatment for hepatitis C virus (HCV), there is a period when HCV viral load in the blood is undetectable. If this period of undetectability lasts for 12 consecutive weeks after the cessation of treatment, it is called a sustained virological response (written as SVR12). This period usually then leads to a further 12 consecutive weeks of undetectable HCV, for a total of 24 weeks of undetectability since treatment cessation (written as SVR24). Historically, a person is considered cured when they have achieved SVR24, they are considered cured. However, many doctors who have had experience with testing the new all-oral regimens of anti-HCV drugs in clinical trials generally consider their patients cured if they have achieved SVR12.
SVR linked to longer survival and other benefits
Leading specialists who study the liver and gastrointestinal tract have been conducting research to explore the many benefits of HCV treatment and cure (SVR24). They collected health-related information from participants with and without severe HCV-related liver injury. The 10-year survival rate of participants with an SVR was not significantly different from the survival rates of HCV-negative Dutch people of the same age and gender over the same period of time. Thus, even for people with severe liver injury, getting an SVR can lead to broadly similar rates of survival as HCV-negative people.
Issues with emerging therapies for HCV
In Canada and other high-income countries, most people cannot afford to pay for the high cost of treating and managing catastrophic illnesses such as HIV, HCV and cancer. In response to this situation, regional health authorities have established formularies—lists of drugs that are subsidized by the state. Until a drug is listed on the formulary, most patients cannot get access to it. The formularies negotiate with pharmaceutical companies about the cost of their drugs. This back and forth between the formularies and companies takes time. The cost of the new Hep C treatments will be high and it is not clear when they will be on every formulary. Formularies can also put restrictions on who can get their listed medicines.
Simeprevir + sofosbuvir – experience in the clinic
Leading hepatitis C virus (HCV) researchers in Canada, Germany, New Zealand and the U.S. have formed a research group called HCV Target. The purpose of Target is to conduct observational studies of emerging therapies for HCV. Data are captured from medical records from HCV clinics in the participating countries and placed in a shared database. Target is an ongoing collaboration and not all results are available, so we are presenting the preliminary results in this article.
Holkira Pak approved in Canada for genotype 1
Holkira Pak is the brand name for the suite of AbbVie drugs licensed in Canada and the U.S. for the treatment of hepatitis C virus (HCV) genotype 1. In TreatmentUpdate 207 we present some research findings on Holkira Pak from clinical trials that demonstrate its power and safety.
Holkira Pak – results in genotype 1a without severe liver injury
Nearly 3,000 people with hepatitis C virus (HCV) genotype 1 have received Holkira Pak in clinical trials. Genotype 1b responds relatively well to the new and powerful anti-HCV drugs such as Holkira Pak and Harvoni. Past experience with boceprevir and telaprevir suggests that strains of genotype 1a are harder to treat. We now focus on clinical trial results from participants with genotype 1a who were treated with Holkira Pak with and without ribavirin. These results, particularly among participants who received ribavirin, are very promising.
Holkira Pak – results in genotype 1a with severe liver injury
AbbVie researchers analysed data from participants with genotype 1a with severe liver injury who used Holkira Pak and ribavirin and found generally favourable results.
Holkira Pak – effectiveness in people with kidney dysfunction
People with chronic hepatitis C virus (HCV) infection can also develop kidney injury and dysfunction. Historically, people with HCV who also have kidney dysfunction have not responded well to combination therapy with peginterferon and ribavirin. Prior to testing Holkira Pak in HCV-positive people with kidney dysfunction, AbbVie conducted a study to assess the safety and effectiveness of two regimens in HCV-negative people who have kidney dysfunction.
Holkira Pak – effectiveness in people with liver transplantation
In cases of severe liver injury due to hepatitis C virus (HCV) infection, doctors may refer patients to a transplant centre. However, in cases where patients are transplanted with a healthy liver, HCV generally recurs after this procedure. Furthermore, the transplanted liver may become injured because of the recurrence of HCV. In an ongoing phase II clinical trial called Coral-1, researchers are assessing the safety and effectiveness of Holkira Pak + ribavirin in participants who have received a liver transplant and who also have HCV infection.
II HIV AND TRANSPLANTATION
HIV and liver transplants in British Columbia
People with HIV infection may experience liver injury because of co-infection with hepatitis B and/or C viruses. In some cases of severe liver injury, a liver transplant may become necessary. Doctors in Vancouver, British Columbia, have had experience performing a limited series of liver transplants in HIV-positive people. So far, all four patients who received liver transplants have recovered from surgery and are doing well.