Basic Hep C Treatment Terms

Basic Hep C Treatment Terms One May Encounter while Researching Hep C TreatmentsThis page contains a list of basic hepatitis C treatment terms one may encounter while researching hep C treatments. At the bottom of this list there are links to more information about hepatitis C/hep C/HCV (hepatitis C/hep C/HCV all mean hepatitis C).

The Hepatitis C Virus and its Treatments (The Basic Facts)
The hep C virus (HCV) spreads through blood. It infects cells and then uses those cells to create new copies of itself. Those copies then leave those cells and move on to infect others, creating more and more copies.

Therefore, the goal of hep C treatment is to stop this replication to such an extent that a person’s HCV viral load, the amount of virus within them, is lowered so much that it is undetectable six months after completing treatment. It is called a sustained viral response, or SVR, when this happens. When SVR is achieved, the virus can no longer be detected in the blood and liver disease from hep C has halted, however, studies have shown that a long-term risk for liver cancer still remains.

For more information, Hepatitis Education Canada has a video about basic hepatitis C information that can be played in multiple languages. The Hepatitis C: The Basics interactive on-line learning module also has more information about hep C.

Hepatitis C Basics on-line course ad
The BC Centre for Disease Control has created Hepatitis C: The Basics. It is a free, go-at-your-own-pace learning module. It covers: how hepatitis C is spread, how to get tested, how best to live with the disease, and how to manage treatment and post treatment.

Furthermore, the documentary film “Deal with it: Untold stories of hepatitis C in Canada” exposes the state of Canada’s Hepatitis C epidemic, one of the most pressing but least discussed health concerns facing the country today, can be watched here for free.

Canadian Drug Expert Committee (CDEC)
A Canadian advisory committee that makes recommendations to federal, provincial, and territorial publicly funded drug plans.

Chronic
Lasting a long time without going away.

Common Drug Review (CDR)
Through the Common Drug Review process, CADTH conducts thorough and objective evaluations of the clinical, economic, and patient evidence on drugs, and uses this evaluation to provide reimbursement recommendations and advice to Canada’s federal, provincial, and territorial public drug plans, with the exception of Quebec.

Formulary
A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage.

Hep C Antibody Test
The hep C antibody test is a blood test that is done to find out if one’s immune system has made antibodies to fight the hep C virus.  This is the first test done to see if someone has hep C. A person who has been exposed to the hep C virus – whether the virus is still in their bloodstream or not – will always have hep C antibodies. This doesn’t mean that they still have the virus.

Hep C Genotype
A hep C genotype is a strain/type of hep C/classification of the hep C virus based on the genetic material in the virus’s RNA (Ribonucleic acid) strands. There have been eleven hep C genotypes, with several different subtypes, identified throughout the world. Only six are common.  The most common hep C genotype in Canada is known as the hepatitis C virus genotype 1 (HCV GT1 or just GT1). A person can become infected with more than one genotype, so prevention (following the basic rules for staying healthy) and harm reduction are always important. Knowing one’s hep C genotype is important as it affects the type of treatment prescribed, the treatment’s duration, and the treatment’s success.

Hep C genotyping, testing to see what hep C genotype a person is infected with, has to be repeated when the person has genotype 1 and was tested before May 2012. This is because before then, the test didn’t discriminate between genotypes 1a and 1b. When Galexos (simeprevir) is considered Q80K resistance testing is required.

More information can be found in the BC government’s Hepatitis C Genotypes Healthlink’s file. or in the Hepatitis Education Canada mini-video, What is a hepatitis C genotype?

Liver Cirrhosis
A condition that occurs when non-functioning scar tissue, tissue not healthy enough to help the liver work, replaces large amounts of normal functioning liver tissue. The scar tissue can be caused by lengthy injury or illness, such as chronic alcohol abuse or hep C. Symptoms, when they occur, include poor appetite, weight loss, fatigue, and just plain feeling sick. One is said to be cirrhotic when they have liver cirrhosis.

Liver Damage: In about a month, the liver can heal from small amounts of damage, such as the damage caused by a Tylenol overdose. More and more studies are also finding that the liver can repair itself after damage has been done.

Update: Currently, exciting research is being done to figure out just how much a liver can heal after hep C treatment. It looks like the liver may be able to heal itself after treatment. Non-scientific information here.

More information can be found in Understanding Cirrhosis of the Liver: First steps for the newly diagnosed, an easy-to-read resource that was put together by CATIE and the Canadian Association of Hepatology Nurses.

Liver Fibrosis
A Liver fibrosis is the early stage of liver scarring. It happens when a liver tries to heal itself and in the process creates scar tissue that can’t do the work of normal liver cells. Fibrosis doesn’t cause symptoms but can lead to portal hypertension or liver cirrhosis. A liver biopsy is used to diagnosis it. Fibrosis can be stopped and some of the changes reversed if the underlying condition is treated.

Liver Fibrosis Stages
There are five stages of liver fibrosis, stage 0 to stage 4. Stage 0 means a liver is normal and doesn’t have fibrosis. Stage 4 is liver cirrhosis. BC PharmaCare requires a patient to have liver fibrosis stage 2 or higher in order to qualify for hep C treatment coverage. At stage 2, one may not know that their liver is damaged and may not be experience symptoms such as yellow skin or eyes or abdominal pain.

Notice of Compliance (NOC)
Receiving a notice of compliance allows the treatment to be sold in Canada with official approval. If a drug has a notice of compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. At this stage private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).

Null or Partial Response/rs
There are two forms of virologic non-response that are important to distinguish from each other: null response and partial response. Null response is when treatment doesn’t suppress the virus. Partial response saw decreased of hep C at 12 weeks but undesirably high HCV RNA levels in the blood at week 24. Both types of patients went through unsuccessful hep C treatments.

PCR Test/HCV RNA
This test tells if the virus is present in one’s body and confirms the diagnosis of hepatitis C. The PCR test will also tell how much virus (viral load) there is and may, depending on the type of PCR test ordered, tell the genotype (strain) of hep C a person has.

PharmaCare Limited Coverage Drugs
BC PharmaCare’s limited coverage drugs are treatments that require patients to meet criteria pre-defined by PharmaCare to get their costs covered. Actual coverage depends on rules of the patient’s PharmaCare plan, including any annual deductible requirement. The hep C treatments covered by PharmaCare are all Limited Coverage Drugs that require Special Authority.

PharmaCare Special Authority
PharmaCare Special Authority grants coverage of a drug, medical supply, or medical device that otherwise would not be covered or that would only be partially covered. Coverage is provided for patients with specific medical circumstances and the actual reimbursement depends on the patient’s PharmaCare plan rules, including any annual deductible requirements. To receive coverage, Special Authority approval must be in place before the patient purchases the prescription. Coverage cannot be provided retroactively. The hep C treatments covered by PharmaCare are all Limited Coverage Drugs that require PharmaCare Special Authority.

Relapse
When treatment has been successful but over time the virus has come back.

SVR
SVR stands for Sustained Viral Response. There is a time period, right after hep C treatment has been completed, when the HCV RNA, or the hep C virus, isn’t detectable in one’s blood. If the virus remains consistently undetectable over time, the chances of it coming back, or relapsing, are extremely low (less than 1%). When this happens, a SVR is thought to have been achieved.

Achieving SVR is the goal of hep C treatments. It is considered to be an hep C infection “cure”, a successful treatment. When it is achieved, the hep C virus can’t be detected in the blood, can’t be spread, and the progression of liver damage may stop or may slow down.

Currently, hep C treatments in clinical trials are usually listed with SVR12s or SVR24s. The numbers after ‘SVR’ are the number of weeks that the virus must remain undetectable for the treatment to be declared successful. For example, if SVR24 95% is listed for a treatment, it means that 24 weeks after that treatment has been completed, 95% of patients had such low levels of HCV RNA within them that they were declared cured. If SVR12 95% is listed, it means the same thing but after only 12 weeks of testing for the virus instead of 24 weeks.

CADTH has stated that based on input from hep C experts, a difference of 5% or less in treatment SVRs is considered unlikely to reflect a difference of clinical importance.

Treatment-Experienced / Previously Treated Patients
Patients who have already unsuccessfully tried to cure their hep C with usually pegylated interferon or an older generation of hep C treatment.

Treatment-Naive Patients/Patients who have never tried treatment
Patients who have never tried to cure their hep C.

Viral Load
The amount of virus (hep C RNA) in a given volume of blood. Viral loads during treatment are not predictive of whether or not a sustained virological response (SVR) will be achieved.

Viral Load Test
A Viral Load Test looks at the amount of virus (hep C RNA) in a given volume of blood. IU/ml is that given volume of blood used in reporting the test results and means International Units per milliliter. If one takes Sovaldi or Harvoni, the test is often preformed within 6 months prior to the start of treatment, at the end of treatment, and 12 and/or 24 weeks after treatment. If one is treated with pegylated interferon and ribavirin, testing recommendations are:

  • 6 months prior to the start of treatment
  • Week 4 viral load monitoring (genotype 2)
  • Week 4 and 12 viral load monitoring (genotype 3)
  • 12 weeks after completion
  • 24 weeks after completion

For example, while taking Galexos (simeprevir), patients with a level of < 25 IU/ml at 4 weeks of treatment, are prescribed an additional 36 weeks as shorter treatment durations have higher relapse rates. More information about viral load testing and genotyping was put together by the BC Centre for Disease Control in June 2015.

If you have any other terms to suggest, please let the Hep C Treatment Information Project know and we will update this list!

Further Links and Resources

  • Hepatitis Information in Different Languages by Hepatitis Education Canada
  • Hepatitis C: English by Hepatitis Education Canada is a page all about hepatitis C/hep C/HCV and links to information about prevention, harm reduction, symptoms, testing, and support
  • Resources has links to more information about hep C symptoms and living well with hep C
  • Hep C Drug Pipeline summarizes the treatments that are currently making their way through the hep C drug pipeline towards approval
  • Comparing Hep C Treatments compares the hep C treatments currently covered by BC’s PharmaCare and many other healthcare systems

References:

British Columbia Health. (2015). About PharmaCare. Retrieved June 12, 2015, from http://www2.gov.bc.ca/gov/topic.page?id=1062124B36EF47E28CEBF11067DF4CD8

Hep editorial team. (2015, January 12). Hepatitis C: The Basics: How is it diagnosed, and what tests are used? Retrieved June 12, 2015, from http://www.hepmag.com/articles/2512_18753.shtml

Merck. (2015). The Merck Manuals. Retrieved June 12, 2015, from https://www.merckmanuals.com

World Health Organization. (2015). Hepatitis C: The hepatitis C virus. Retrieved June 12, 2015, from http://www.who.int/mediacentre/factsheets/fs164/en/