Combination Therapy For Chronic Hepatitis C Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|First Posted : March 6, 2013Results First Posted : April 11, 2017Last Update Posted : June 8, 2017|
- Study Details
– GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the body. Researchers want to see whether GS-7977 can be combined with any of the other three drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.
– To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection.
Individuals at least 18 years of age who have chronic HCV infection and have never been treated for it.
Individuals at least 18 years of age who have chronic HCV infection and have not responded to interferon therapy.
Individuals at least 18 years of age who have chronic HCV infection with advanced liver disease and have never been treated for HCV
|Drug: SofosbuvirDrug: LedipasvirDrug: GS-9669Drug: GS-9451||Phase 2|
Will A Specialist Need To Be Involved
In order to prescribe, general practitioners including physicians with expertise in viral hepatitis, will be required to first consult with a gastroenterologist, hepatologist or infectious diseases physician to ensure patients with liver disease or other complex needs are appropriately referred to specialist care. A face to face consult with the specialist is not required and patients with complex needs will likely be referred to specialist care where appropriate.
Patients affected by hepatitis C with severe or advanced liver disease may still need to access the treatments under the care of a specialist – such as a gastroenterologist, hepatologist, or an infectious disease physician with experience in treating chronic hepatitis C infection.
Understanding Hepatitis C Genotypes
There is a range of medications for hepatitis C because no single drug works for everyone.
Medications may vary depending on the amount of liver scarring a person has and the viruss genotype.
A genotype refers to the genes that make up the hepatitis C virus. All genotypes cause similar liver damage, but the long-term effects may differ.
Hepatitis C has seven genotypes. Doctors represent these types by using the numbers 1 to 7. The genotype is type 1 hepatitis C. There are also subgroups within these groups, such as hepatitis 1a and 1b.
Knowing which genotype a person has is crucial in getting the proper treatment.
suggests ribavirin effectively treats several genotypes, but it does not work on its own. So the doctor will prescribe another medication to take with ribavirin to treat hepatitis C.
Other facts about ribavirin include:
- Treatment duration depends on other drugs a person is taking.
- The dosage depends on the persons body weight.
- A person will need their blood levels frequently checked while taking the medication to monitor efficiency and toxicity.
- Ribavirin may also cause congenital anomalies. Avoid ribavirin while pregnant or if trying to conceive.
Combination drugs tend to be effective for most or all hepatitis C genotypes.
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What Are The New Hepatitis C Treatments And When Will They Be Available
Recent advances in antiviral treatment have led to the development of new highly effective drugs for the treatment of all types of hepatitis C.
The new hepatitis C treatments are sofosbuvir with ledipasvir sofosbuvir daclatasvir and ribavirin .
These new treatments will be available on the Pharmaceuticals Benefits Scheme from 1 March 2016.
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First Regimen To Treat All Six Major Hcv Genotypes
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis . For patients with moderate to severe cirrhosis , Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C, said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDAs Center for Drug Evaluation and Research.
The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis . Results demonstrated that 9599 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis , of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.
Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.
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Factors That Affect Treatment Success
A number of factors can help predict how well hepatitis C treatment is likely to work for you.
Before starting treatment, it is important to have a test to see what genotype of hepatitis C you have. This determines which DAAs will work and predicts treatment response. Some DAAs are pangenotypic or active against all genotypes.
There are at least six major hepatitis C genotypes. Genotype 1 is the most common type in the UK, Europe and the US. It has two subtypes, 1a and 1b. Genotype 1 was hard to treat with interferon-based therapy, but it can be successfully treated with all approved DAAs. However, genotype 1a is harder to treat than 1b.
How well something works . See also efficacy.
Hepatitis C genotype 2 is less common worldwide. It responded best to interferon-based treatment, but is susceptible to fewer DAAs than genotype 1. Genotype 3 is the most common type in the Indian sub-continent and south-east Asia, but it is also found in the UK. Genotype 3 has been the hardest to treat with DAAs, but newer pangenotypic drugs are highly effective against it.
Genotype 4 is the most common type of hepatitis C in the Middle East and North Africa, but it has also been seen in hepatitis C outbreaks in the UK and Europe. Genotype 4 generally responds to the same DAAs as genotype 1. Genotype 5 and 6 are less common and less well studied.
Ribavirin Can Cause Birth Defects
Ribavirin may cause birth defects if its taken before or during pregnancy. If you or your partner are taking ribavirin, its important to avoid pregnancy while taking the drug. In addition, pregnant people should not have sexual intercourse with a person assigned male at birth who is taking ribavirin.
If you are planning to try to become pregnant, it is important to wait until after you have stopped taking ribavirin. People assigned female at birth must wait 9 months after stopping ribavirin before starting a pregnancy. People assigned male at birth must wait 6 months after stopping the drug before they attempt pregnancy with their partner.
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What Are The Symptoms Of Hepatitis C
Most people infected with hepatitis C have no symptoms. Some people with an acute hepatitis C infection may have symptoms within 1 to 3 months after they are exposed to the virus. These symptoms may include
If you have chronic hepatitis C, you most likely will have no symptoms until complications develop, which could be decades after you were infected. For this reason, hepatitis C screening is important, even if you have no symptoms.
What Does It Mean To Have A Successful Treatment What Is A Sustained Virologic Response
In an untreated state, the hepatitis C virus infects the cells of the liver and then continuously lives there, making copies of itself that circulate in the bloodstream. Antiviral medications can destroy the ability of the virus to reproduce, so the amount of virus in the bloodstream then decreases. The amount of virus in the blood is measured by aviral load.
Treatment is successful when the viral load drops toundetectablelevels, which means the virus cannot be detected in the bloodstream at all. The viral load becomes undetectable during treatment and remains undetected after treatment has ended. If there is still no detectable virus in the blood 12 weeks after the end of the treatment, the treatment was successful. This is called a Sustained Virologic Response .
A patient who has achieved an SVR is considered to be cured of the hepatitis C virus.
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A Hidden Epidemic Of Hepatitis C
Hepatitis C is the most common infectious disease in injecting drug users, among whom it is usually transmitted through the sharing of injecting equipment such as needles and syringes. Most of those who become infected go on to develop chronic HCV infection, which can lead to severe health problems in individuals and place a major burden on health care systems. Yet hepatitis C is both preventable and curable, and interventions in this field, particularly the development of new medicines to treat hepatitis C, are making rapid progress.
Hepatitis C virus infection is highly prevalent in injecting drug users across Europe, with national infection rates for this group ranging from 18% to 80%. However, infected individuals often show no noticeable symptoms, and many are unaware that they are carrying the virus, leading to it being referred to as a hidden epidemic. Injecting opioid users in Europe constitute an ageing population, which includes many who have been living with hepatitis C for 15 to 25 years. The natural history of chronic hepatitis C virus infection and the ageing cohort effect in this population mean that a large burden of advanced liver disease can be expected over the next decade.
Barriers To Accessing Hepatitis C Treatment
In spite of recent improved treatment outcomes for hepatitis C patients, available data show treatment uptake continues to be very low among injecting drug users. The literature highlights a number of possible reasons for this. Service providers cite concerns around adherence, risk of exacerbation of psychiatric disorders and the potential for reinfection after treatment as reasons for not assessing or treating hepatitis C in injecting drug users . On the part of patients, the lack of access of people who inject drugs to testing still constitutes a key-barrier to entering a care pathway. In addition, poor knowledge about hepatitis C and treatment availability, the absence of noticeable symptoms and the perceived side-effects of treatment are named as barriers for accessing hepatitis C care. Finally, until recently, current drug injecting was an exclusion criterion for receiving government-funded hepatitis C antiviral treatment in a number of European countries. This obstacle, however, is now being removed, with most clinical guidelines revised to allow for the treatment of hepatitis C in injecting drug users.
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Treatment For People With Hiv And Hepatitis C Co
In the UK, standards for HIV treatment and care are set and monitored by the British HIV Association , the professional association for HIV doctors and other healthcare professionals. The most recent guidelines on HIV and hepatitis co-infection were produced in 2017 . Experts now agree that treatment recommendations for people with HIV and hepatitis C should be the same as for everyone else with hepatitis C, so your treatment will follow national guidelines for hepatitis C treatment.
Like everyone else living with HIV, people with HIV and hepatitis C co-infection are advised to start antiretroviral treatment soon after being diagnosed with HIV. People with co-infection may particularly benefit from early treatment because having well-controlled HIV and restored immune function reduces the risk of liver disease progression.
Current guidelines recommend that everyone with HIV and HCV co-infection should start hepatitis C treatment with DAAs. Treatment is especially urgent if you have moderate or worse liver fibrosis . But everyone with HIV and hepatitis C co-infection can benefit from early hepatitis C treatment because their liver disease may progress faster than it would in an HIV-negative person. Where there is a waiting list for treatment, people with HIV and hepatitis C co-infection are likely to be prioritised, especially if you have moderate or severe fibrosis.
You Can Have It And Not Know It
What is Hepatitis C?
Hepatitis C is a liver disease caused by the hepatitis C virus . HCV is far more infectious than HIV. Presently, there is no vaccine to prevent HCV infection.
In 2011, it is estimated that over 220,000 people in Canada were infected with HCV. In 2012, 10,180 new cases of hepatitis C were reported in Canada. It has been estimated that over 40% of people living with chronic hepatitis C dont even know they are infected.
About 15 to 25 percent of adults will recover within 6 months of becoming infected . The remaining 75 to 85 percent are unable to clear the virus and will become chronically infected. Chronic hepatitis C is treatable and in some instances can be cured.
Why is hepatitis C a health concern?
Many people infected with HCV do not know they have the virus because symptoms can take two to six months to appear and the majority of people will not develop symptoms. During this time, they can spread the infection to others. You may not know you have this infection until damage has already been done to your liver. Potential complications from chronic hepatitis C include cirrhosis of the liver, liver failure, liver cancer and premature death.
Why do I need my liver?
How is hepatitis C virus spread?
The most common risk factors for HCV infection include:
What are the symptoms of hepatitis C?
How can I find out if I have hepatitis C?
How can I protect myself and others against HCV?
What if I have hepatitis C?
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What Other Drugs Will Affect Harvoni
When you start or stop taking Harvoni, your doctor may need to adjust the doses of any other medicines you take on a regular basis.
If you also take an antacid: Wait at least 4 hours after taking the antacid before you take ledipasvir and sofosbuvir.
If you also take a stomach acid reducer: You may need to wait 12 hours after taking the stomach acid medicine before you take ledipasvir and sofosbuvir. This includes cimetidine, famotidine, nizatidine, ranitidine, Axid, Pepcid, Tagamet, Zantac, and others.
Many drugs can interact with ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Some of the main differences between hepatitis B and C are:
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Hepatitis C is an infectious disease that generally causes only mild or no symptoms initially, but the virus quickly goes on to reside in the liver of about 85% of people who get infected. Chronic HCV can lead to scarring of the liver and ultimately to cirrhosis, which may only become apparent after many years. In some cases, those with cirrhosis will also develop liver failure or liver cancer.
It is estimated that 150 to 200 million people, or about 3% of the world’s population, are living with chronic HCV. About 3 to 4 million people are infected per year, and more than 350,000 people die yearly from HCV-related diseases. In 2010, an estimated 196,000 deaths occurred from liver cancer secondary to the HCV infection.1
In the United States, there are approximately 3.2 million people with chronic HCV infection. Interestingly, the baby boomersthose born between 1945 and 1965represent the largest segment of the US population with this infection, the majority of whom were likely infected during the 1970s and 1980s when rates were highest.2
On December 6, 2013, sofosbuvir was approved by the FDA. Sofosbuviran oral therapy, taken as tabletsis used as part of a regimen for the treatment of chronic HCV infection caused by viruses of genotypes 1, 2, 3, or 4.
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Medical Treatment For Hepatitis A B & C
Treatment for hepatitis A, B, or C is based on which type of hepatitis is present in the bloodstream and the severity of the resulting liver damage. Depending on the results of diagnostic tests, our specialists at NYU Langone may recommend antiviral medication to stop the virus from replicating and protect your liver from further damage.
Symptoms Of Hepatitis C
Hepatitis C often doesnt have any noticeable symptoms until the liver has been significantly damaged. This means many people have the infection without realising it.
When symptoms do occur, they can be mistaken for another condition. Symptoms can include:
- flu-like symptoms, such as muscle aches and a high temperature
- feeling tired all the time
- loss of appetite
Read more about the complications of hepatitis C.
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