Newly Diagnosed

For anyone who has been diagnosed with a serious disease what follows is often fear of the unknown. As the weeks turn into months the realization sinks in that you have a heath crisis on your hands. Quickly you find yourself seeking out information, looking for the right answers and asking yourself a few familiar questions; What can I do to improve my condition? Can this disease be treated, if so, when should I start treatment, or should I wait ?

For the millions of people who have been diagnosed with hepatitis C, the same questions need to be answered.

In this blog post links are provided to help you understand more about hepatitis C, from necessary tests needed to distinguish between active or a previous HCV infection, to current FDA approved therapies to treat the virus, and so much more.

History Of HCV
2016
Nezam Afdhal | TEDxOxford

Need To Talk To Someone ?
Launched in 2015
Hepatitis C CareLine, providing individualized, sustained assistance to patients diagnosed with Hepatitis C. The CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.

Who Should Get Tested

New Hepatitis C Infections Nearly Tripled over Five Years
The rising number of hepatitis C infections are primarily a result of increasing injection drug use associated with America’s growing opioid epidemic, according to the federal Centers for Disease Control and Prevention. Over five years, the number of new infections has nearly tripled, reaching a 15-year high. The highest number of new infections are among 20- to 29-year-olds.

Where Can I find a specialist to treat HCV?
Testing, Diagnosis and Treatment

The Disease
Following initial infection with HCV, approximately 75 to 85% of persons develop chronic infection. Among those with chronic infection, approximately 20 to 30% will eventually develop cirrhosis. Patients who have HCV-related cirrhosis have a 2 to 7% per year risk of developing either end-stage liver disease or hepatocellular carcinoma.

Virus-caused hepatitis has become a leading cause of death and disability in the world, killing more people in a year than AIDS, tuberculosis or malaria, a report said today.

​Viral hepatitis-related mortality increased by 63% over a 23-year period, whereas mortality from other infectious diseases, such as HIV, tuberculosis and malaria have decreased, according to newly published data in The Lancet.
Who Should Be Treated?
Cirrhosis is the most important risk factor for hepatocellular carcinoma (HCC) regardless of the etiology of cirrhosis. Compared to individuals who are anti-hepatitis C virus (HCV) seronegative, anti-HCV seropositive individuals have a greater mortality from both hepatic as well as nonhepatic disease processes. The aim of this paper is do describe the burden of HCV infection and consider treatment strategies to reduce HCV-related morbidity and mortality. 
​Read the complete 2016 article, here.

In The News
2017
TWO NEW COMBINATION DRUGS APPROVED FOR HCV GENOTYPES 1–6
 Mavyret (AbbVie) and Vosevi (Gilead Sciences)

Mavyret
Glecaprevir/pibrentasvir (Mavyret—AbbVie) is the first 8-week treatment approved for all chronic hepatitis C virus (HCV) genotypes 1–6 in adult patients without cirrhosis or with mild cirrhosis who have not been previously treated, including patients with moderate to severe kidney disease and those on dialysis. It is also approved for adult patients with HCV genotype 1 infection who have been previously treated with an NS5A inhibitor or an NS3/4A protease inhibitor (but not both). Previously, the standard treatment length was 12 weeks or more.

The most common adverse reactions in clinical trials were headache, fatigue, and nausea. The agent is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and those taking the drugs atazanavir and rifampin.

Vosevi
A fixed-dose combination tablet containing two previously approved drugs, sofosbuvir and velpatasvir, and a new drug, voxilaprevir, was approved under the trade name Vosevi (Gilead Sciences) to treat adults with HCV genotypes 1–6 without cirrhosis or with mild cirrhosis. It is the first approved treatment for patients who have been previously treated with the direct-acting antiviral (DAA) drug sofosbuvir or other drugs for HCV that inhibit the NS5A protein. Treatment recommendations differ depending on viral genotype and prior treatment history. The drug is contraindicated in patients taking rifampin.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV-coinfected adult patients who were undergoing or had completed treatment with HCV DAAs and were not receiving HBV antiviral therapy. Patients should be screened for evidence of current or prior HBV infection before starting treatment with either Mavyret or Vosevi.
Source - September 2017Volume 23, Issue 9, Pages 12–13

August 2017
Treatment with DAAs reduces the risk of mortality in the first 18 months after the completion of treatment
Michael Carter
Published:10 August 2017
The study – published in Clinical Infectious Diseases – matched people who received therapy with all-DAA regimens with untreated controls. Mortality rates in the first 18 months after therapy were significantly lower among people who received DAAs. After controlling for other factors, treatment with DAAs was associated with a 57% reduction in the risk of death.

View current research articles: Cure - Achieving sustained virologic response (SVR) in hepatitis C

April 2016
Where Can I find current information on treating HCV?
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.
The guidelines will have a complex algorithm for practitioners around the country to follow and see what's the right treatment, for the right patients, for the right about of time. The document is easy to comprehend, which benefit patients considering HCV therapy. When new HCV drugs are approved, and new real world data is established, the guidelines are updated. In July/2016 the HCV Guidelines were updated to reflect the recent approval of Epclusa (Sofosbuvir/Velpatasvir).
Stay current with all guideline updates, click here.

Treatment Action Group (TAG)
February 2017
New Fact Sheets On Hepatitis C Drugs And Genotypes
Treatment Action Group announces - New and Updated HCV Treatment Fact Sheets Now Online
New fact sheets include; HCV Genotypes, Epclusa and an updated fact sheet on Viekira XR and Technivie. Check the site often for the most recent updates.
Begin here....
HCV Guideline - Links

Starting Treatment
For patients that have not been treated - Treatment-Naïve Patients

Starting Treatment
For patients that have treated before without success

HCV Advocate
The "Peoples Website" also known as HCV Advocate is a great place for reviewing easy to understand conference coverage, basic information as well as updates on newly FDA approved drugs. Click here to find out what's new.

Recently HCV Advocate launched an incredible new; HCV Medications Blog with easy to find information; listed clearly by HCV genotype. ​Easy to navigate, easy to read.

Each month HCV Advocate puts out a newsletter with helpful articles about living with or treating the virus. An overview of approved drugs or agents still under investigation is offered as well.

Index Of All Hepatitis C Newsletters - Published Monthly
Catch up on current HCV information, breaking news or learn about clinical studies, read personal stories from people who are living with or treating the virus. 
Start here.........

HEPATITIS C SYMPTOMS
When you are first exposed to the hepatitis C virus and become infected, you are said to have "acute hepatitis C". Most people have no symptoms of infection during this time.

In 70 to 80 percent of people, the infection becomes chronic. The word "chronic" implies that the infection will be prolonged, or even lifelong, unless you get treatment that cures the infection.

Many people with chronic hepatitis C have no symptoms, even if there is serious liver damage. Of those who do develop symptoms, the most common symptom is fatigue; other less common symptoms include nausea, lack of appetite, muscle or joint aches, weakness, and weight loss.

Many individuals with hepatitis C are asymptomatic. They are not aware that they have an infection. However, they will probably experience some symptoms as the condition progresses, because of the increasing damage to the liver. For this reason, it is extremely important to diagnose hepatitis C infection in its early stages to minimize or avert potential serious complications.

Related

Conditions that may be associated with HCV

Extrahepatic Manifestations
Review this series of great articles on the extrahepatic manifestations of HCV.
Published in Journal of Advanced Research
Volume 8, Issue 2, March 2017, Pages 85–87

Index Of Articles
Begin here...

Updates on the blog - Other Conditions Related To HCV

Transmission Of Hepatitis C
How is hepatitis C spread? Who's at risk?
Hepatitis C virus (HCV) is transmitted through contact with an infected person's blood. The following list outlines sources of hepatitis C transmission
-Sharing needles and syringes (IV drug abuse);
-Other possible risk behaviors: tattoos, body piercing, living and medical care in a developing country, folk medicine, intranasal cocaine;
-Extensive surgical procedures
-Unknown--up to 5% of patients have no identifiable risk factors;
-Sexual transmission is rare; the risk of sexual transmission to an individual is probably less than 3% when a person is in a stable monogamous relationship;
-Vertical transmission from mother to baby
-Reused needles in a medical or health care setting.

In The News

Transmission - Baby Boomers
The Stigma Stops Here
May 30 2016
Listen

A new report indicates the hepatitis C (HCV) epidemic peaked between 1940 and 1965 with reused medical syringes to blame, not injection drug use or high risk sexual practices among baby boomers, as has often been claimed.
Researchers and advocates alike hope this new information will help dispel some of the stigma attached to having hep C — particularly for older adults — and encourage more people to get tested and connected with potentially life-saving treatment. The research is further proof that anyone born between 1945 and 1964 should be tested for HCV, even if they feel like they've never been at risk. Published in The Lancet Infectious Diseases journal, the research shows that the hepatitis C epidemic can be traced to hospital transmissions caused by the practice of reusing needles in medical settings.

Is hepatitis C transmitted sexually?
According to studies in the Journal of the American Medical Association, a low sexual transmission rate of hepatitis C was suggested. Of the 62 patients studied, none of the monogamous heterosexual partners had developed the hepatitis C antibody. In general, the probable risk of heterosexual transmission of hepatitis C is less than 3%.
It is recommend that all patients in a non-monogamous relationship use a condom or spermicide and patients in a monogamous relationship use a barrier method only if they are anxious or concerned about transmission.

All non-monogamous individuals should use safe sex practices.

For patients with hepatitis C, testing of spouses, babies and significant others is recommended by Centers for Disease Control(CDC). Please discuss these issues with your physician.

The HCV partners study
Sexual transmission of hepatitis C virus among monogamous heterosexual couples: The HCV partners study.

Links


Is hepatitis C transmitted by breast milk to infants?
There is no substantial evidence that hepatitis C is transmitted through breast milk, however, a few studies have been performed that tested breast milk and very rarely is hepatitis C found in the breast milk--even using the most sensitive tests such as PCR. The CDC has issued a statement explaining that mothers who have HCV can breast feed, but should avoid it if there are sores around the nipple.

In an editorial published with the paper online September 24 in The Journal of Infectious Diseases, Dr. Ravi Jhaveri from the University of North Carolina in Chapel Hill says "the results provide a plausible explanation for why breastfeeding is not a risk factor for HCV transmission. This is reassuring for us as practitioners when we counsel our HCV patients that it is safe for them to breastfeed."

Can hepatitis C be transmitted to other members of my family (household contacts)?
There is a slight risk of hepatitis C transmission among household contacts, so family members should not share items such as razors or toothbrushes that may transmit blood or secretions. Women who have hepatitis C and are menstruating as well as men or women with hepatitis C and sores in the genital area should avoid sexual contact. The CDC recommends that spouses or partners of a hepatitis C patient be tested for hepatitis C.

Can a pregnant woman give hepatitis C to her baby?
A report in New England Journal of Medicine suggested a 7% transmission rate of hepatitis C from mother to child at birth. Though this is a high estimate, the possibility of transmission must be considered when a woman with hepatitis C is deciding whether to have children.

For infants who have received the hepatitis C virus from their mother, brief elevations of liver enzymes may occur, but no chronic liver disease has been reported. There have been no reports of cirrhosis in newborns, infants or child due to mother-to-child hepatitis C infection. It is recommended that all babies born to mothers with HCV be tested annually until age three with antibody tests.

In The News
July 2016

October 2013
Infants who get hepatitis C from their mothers during childbirth may inherit a viral strain that replicates more quickly than strains found in non-pregnant hosts, according to a new study published Oct. 27 in Nature Medicine. The findings, from a team in The Research Institute at Nationwide Children's Hospital, are the first to describe how a virus that has infected 180 million people worldwide takes advantage of immune changes during pregnancy

Women with AIDS and hepatitis C are at high risk for transmitting the virus to their babies, and research has shown that these women consistently transmit the virus to their babies at birth.

Is hepatitis C transmitted by insects?
There is no documented transmission of hepatitis C through insects. The virus, however, is related to a group of viruses including yellow fever and Dengue, and those are known to have been spread by insects.

Exams and Tests
February 3, 2017

Lab Results 101: Liver Function Tests
Dr. Pullen
The first thing to know is that what is commonly called liver function testing (LFTs) has little if anything to do with the function of the liver.  They are really tests that are clues to liver injury or disorders, but not really liver function.  Still the name is likely here to stay, so liver function testing is what you will hear discussed.  In the common test ordered at your doctor’s office, called the Comprehensive Metabolic Panel (CMP), several tests are included that give information about the liver.
Continue reading...

2017
All About Fibroscan
A non-invasive test to measure liver inflammation and fibrosis

Hepatitis C Testing
In The News
People with HCV Should Be Tested for HBV Before Starting Antiviral Therapies
The updated information can be found in the Monitoring Patients Who Are Starting Hepatitis C Treatment, Are On Treatment, or Have Completed Therapy section of the Guidance.

The following tests are done to help diagnose, manage and treat hepatitis C:

​The Tests
Diagnosis of HCV infection is based on the detection of  anti-HCV antibodies by enzyme immunoassay.
Anti-HCV test detects the presence of antibodies to the virus, indicating exposure to HCV. This test cannot distinguish between someone with an active or a previous HCV infection. Usually, the test is reported as "positive" or "negative." There is some evidence that if the test is "weakly positive," it may be a false positive. The Centers for Disease Control and Prevention (CDC) suggests that weakly positive tests be confirmed with the HCV RIBA test before being reported.

HCV recombinant immunoblot assay (RIBA) test is an additional test ordered to confirm the presence of HCV antibodies. In most cases, it can tell if the positive anti-HCV test was due to exposure to HCV (positive RIBA) or represents a false signal (negative RIBA). In a few cases, the results cannot answer this question (indeterminate RIBA). Like the anti-HCV test, the RIBA test cannot distinguish between a current or past infection.

Can you have a "false positive" anti-HCV test result?
Yes. A false positive test means the test looks as if it is positive, but it is really negative. This happens more often in persons who have a low risk for the disease for which they are being tested. For example, false positive anti-HCV tests happen more often in persons such as blood donors who are at low risk for hepatitis C. Therefore, it is important to confirm a positive anti-HCV test with a supplemental test as most false positive anti-HCV tests are reported as negative on supplemental testing.

Can you have a "false negative" anti-HCV test result?
Yes. Persons with early infection may not as yet have developed antibody levels high enough that the test can measure. In addition, some persons may lack the (immune) response necessary for the test to work well. In these persons, research-based tests such as PCR may be considered. . How long after exposure to HCV does it take to test positive for anti-HCV? . Anti-HCV can be found in 7 out of 10 persons when symptoms begin and in about 9 out of 10 persons within 3 months after symptoms begin. However, it is important to note that many persons who have hepatitis C have no symptoms..

Hepatitis C RNA assays to determine virus levels (called viral load)
Viral Load Test
How long after exposure to HCV does it take to test positive with Qualitative HCV RNA test =PCR?
It is possible to find HCV within 1 to 2 weeks after being infected with the virus

Unlike antibody tests, HCV RNA tests directly measure for the presence of the hepatitis C virus. HCV RNA tests may be qualitative or quantitative.

Qualitative HCV RNA tests are used to diagnose hepatitis C. Your doctor might choose to perform an HCV RNA test instead of the ELISA, especially if you are at high-risk for hepatitis C. The HCV RNA test will be positive in as little as 1 to 2 weeks after exposure.

A positive HCV RNA test means a person has hepatitis C infection.

Quantitative HCV RNA tests allow your doctor to determine exactly how much virus is in the blood. This is referred to as the viral load.

Recap
There are two types of viral-load tests: qualitative and quantitative.
Qualitative testing checks whether there is hepatitis C virus in the bloodstream (detectable or undetectable).
Quantitative testing measures the amount of hepatitis C virus in the bloodstream. These tests are used during and after HCV treatment to see if it is working and whether a person is cured.​

Viral Load
The viral load is usually expressed as units per milliliter or copies per milliliter. In patients with chronic hepatitis C infection, viral loads vary widely from 50,000 to 5 million copies per milliliter. A higher viral load may not necessarily be a sign of more severe or more advanced disease but it does correlate with likelihood to respond to treatment. HCV RNA tests can also be used to monitor response to hepatitis C treatment. For example, if the viral load decreases during treatment, this suggests that treatment is working and should be continued, referred to as response guided treatment . Conversely, if the viral load remains the same, it suggests that the patient is not responding to treatment.

Viral Load - Familiar Treatment Terms
Response guided treatment - Or viral load monitoring during treatment is intended to enable the physician to determine the duration of combination therapy based on a patients viral response.

Full Text
​October 25, 2016
Directly acting antiviral (DAA) combination therapies for chronic hepatitis C virus (HCV) infection are highly effective, but treatment decisions remain complex. Laboratory testing is important to evaluate a range of viral, host, and pharmacological factors when considering HCV treatment, and patients must be monitored during and after therapy for safety and to assess the viral response. In this review, we discuss the laboratory tests relevant for the treatment of HCV infection in the era of DAA therapy, grouped according to viral and host factors.

Terms Used In Response guided treatment
(RVR)-Rapid Viral Response; Is an undetectable viral load four weeks into treatment. In SOC-standard therapy if you have an RVR your chance of cure is better than 78% and 92% and your doctor may recommend that you shorten your treatment.

(cEVR) Complete early viral response- Is an undetectable viral load 12 weeks into treatment. If you have a complete EVR you have a good chance of being cured .

(pEVR) Partial early viral response - A drop in viral load of at least 2-log (e.g. from 600,000 IU/mL down to 6,000 IU/mL) at 12 weeks of treatment, but still detectable virus in your blood. In people with genotype 1 the chance of viral clearance is low and treatment is generally stopped.

(non-EVR) Non-response- No significant drop in viral load in the first 12 weeks of treatment.

What Is A 100-fold reduction in viral load ?
Changes in viral load are sometimes expressed in terms of logs: a 1-log change means a 10-fold increase or decrease; a 2-log change is a 100-fold increase or decrease.

What Is A 2 Log Drop?
Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL or lower.

Terms Used To Define Patients
Naïve- No prior treatment/first time treating HCV.

Relapsers - People whose viral load drops to an undetectable level with treatment but rises again after treatment ends.

Partial responders- People who have at least a 2 log10 (100-times) drop in viral load, but do not reach undetectable levels in the blood by week 24.

Null responders- People who failed to reduce their viral load by at least 2 log10 (100 times) after 12 weeks of prior treatment, which is the currently recommended Food and Drug Administration (FDA) definition for clinical trials of investigational hepatitis C treatments.

How Will I Know If Treatment Is Working?
The standardized term "SVR" was defined as being HCV RNA negative 6 months after finishing standard therapy. This surrogate endpoint used in clinical trials has been interpreted by researchers as a 'cure'.

Recently, both the Federal Drug Administration (FDA) and the European Medical Agency (EMA) have shortened the post-treatment follow-up period necessary to define an SVR by introducing the so called SVR12, defined as HCV RNA undetectability 12 weeks following therapy.
SVR - sustained viral response
In patients with chronic Hepatitis C virus (HCV) infection, a sustained viral response to treatment regimens 12 weeks after therapy (SVR12) is a good indicator that the response will be maintained until week 24 (SVR 24), based on an analysis of pooled clinical trial data published in the June issue of Gastroenterology. Therefore SVR12 can be used instead of SVR24 as a primary end point for registration trials.

A SVR24 (undetectable levels of HCV RNA in serum 24 weeks after completion of therapy) is considered to indicate successful treatment—most patients who achieve SVR24 maintain their serum-negative status and have reduced complications from liver disease and increased survival times. It is therefore the primary endpoint of HCV therapy trials for regulatory approval—efficacies of all HCV therapies approved by the US Food and Drug Administration have been based on the proportion of patients attaining SVR24. However, earlier time points could increase efficiency of drug development.

Jianmeng Chen et al. assessed data from 15 phase 2 and 3 trials, 3 pediatric studies, and 5 drug-development programs to determine the concordance between SVR24 and SVR12, and even SVR4. They analyzed data from groups of subjects who received various combinations and regimens with interferon, ribavirin, and direct-acting antiviral agents.

Of the 13,599 adult subjects in the database analyzed, 50.6% achieved SVR24 and 51.8% achieved SVR12. These appeared to be mostly the same patients—the positive predictive value of SVR12 for SVR24 was 98% and the negative predictive value was 99% among subjects with genotype 1 HCV infection. A similar level of concordance was observed in subjects with HCV genotype 2 or 3 infections, as well as in pediatric studies.

The positive predictive value of SVR4 for SVR24 was 91% and the negative predictive value was 98% in subjects with genotype 1 HCV infection. Chen et al. observed similar values regardless of subjects’ race, sex, treatment experience, genotype 1a vs 1b, or presence of cirrhosis.

Why is there such a high level of agreement between SVR12 and SVR24, and to a lesser extent SVR4 and SVR24? Chen et al. explained that 65% of subjects who relapsed had detectable viral load by week 4 after treatment and 95% had detectable viral load by week 12. So if the virus is going to reappear, in generally does so within 12 weeks after the treatment ends.

The authors conclude that individual patients should be followed for 24 weeks or longer after treatment to confirm their responses. But SVR12, which is currently used as supportive information for registration trial design, can also be appropriate for regulatory approval of treatment regimens.

Genotype-Test
  • Viral genotyping is used to determine the kind, or genotype, of the HCV virus present. Genotyping is often ordered before treatment is started to give an idea of the likelihood of success and how long treatment may be needed Treatment
2017
Treatment According To Genotypes - News and Updates
A better understanding of genotypes and treatment
​Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities.

Related - HCV Genotypes/Treatment
2016 News Archive

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