Hepatitis C: New Drug Treatment ‘is A Breakthrough’
A new treatment for hepatitis C “cured” 90% of patients with the infection in 12 weeks, scientists said.
The study is a “major breakthrough” and marks a “turning point” in hepatitis C treatment, said experts.
More than 200,000 people are infected with hepatitis in the UK, and deaths from the infection have increased threefold since 1996.
Only 3% of patients in the UK currently opt for the existing treatment, which only works half of the time.
Antiviral Medication For Hepatitis B
Doctors may recommend antiviral medication for people with chronic hepatitis B, which occurs when the virus stays in your body for more than six months.
Antiviral medication prevents the virus from replicating, or creating copies of itself, and may prevent progressive liver damage. Currently available medications can treat hepatitis B with a low risk of serious side effects.
NYU Langone hepatologists and infectious disease specialists prescribe medication when they have determined that without treatment, the hepatitis B virus is very likely to damage the liver over time. People with chronic hepatitis B may need to take antiviral medication for the rest of their lives to prevent liver damage.
There are many different types of antiviral medications available, and your doctor recommends the right type for you based on your symptoms, your overall health, and the results of diagnostic tests. A doctor may take a wait-and-see approach with a person who has a healthy liver and whose blood tests indicate a low viral load, the number of copies of the hepatitis B virus in your bloodstream.
Someone with HIV infection or AIDS may have a weakened immune system and is therefore more likely to develop liver damage. The U.S. Centers for Disease Control and Prevention strongly recommends that people with HIV infection who are diagnosed with hepatitis B immediately begin treatment with antiviral medication.
Antiviral Medication For Hepatitis C
For people with hepatitis C, the goal of treatment with antiviral medication is to prevent the virus from replicating, or copying itself, and to eliminate the virus from the bloodstream. If the hepatitis C virus has been in the body for more than six months, the infection is considered chronic. Without treatment, most people with acute hepatitis C develop the chronic form of the disease.
Your doctor decides which antiviral medicationor combination of medicationsto prescribe based on the results of a blood test called a genotype test. There are six genotypes, or strains, of the hepatitis C virus, and people with certain genotypes respond more quickly to medical treatment.
For many years, the standard treatment for chronic hepatitis C consisted of the antiviral medications pegylated interferon and ribavirin. Ribavirin is taken by mouth every day, and interferon is an injection that you or a caregiver can administer once a week at home.
In 2013 and 2014, the U.S. Food and Drug Administration approved a group of new medications for the treatment of hepatitis C. These medications, which include sofosbuvir, are very effective and have fewer side effects than older medications, particularly interferon.
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Who Can Prescribe The New Drugs
A section 85 listing on the Pharmaceutical Benefits Scheme will allow general practitioners, as well as specialists, to prescribe the new treatments. This means that people with hepatitis C will be able to be treated by a general practitioner in the community. However, people with more advanced care needs, such as cirrhosis, may still need to see a specialist.
Nonstructural 5b Polymerase Inhibitors
The RdRp is vital to HCV replication, acting to catalyze RNA synthesis and genome replication. Nucleoside inhibitors arrest RNA synthesis, while nonnucleoside inhibitors bind and disrupt the RdRp function.
The nucleoside inhibitors are analogues that are incorporated into the viral RNA genome by the RdRp, causing termination of further replication, and competitively bind the active polymerase site. Single mutations can lead to resistance however, there is some evidence that mutations also seem to decrease viral fitness. This class of NS5B polymerase inhibitors has a high barrier to resistance and works broadly against genotypes with intermediate potency. Sofosbuvir was the first available NS5B nucleoside inhibitor .
Nonnucleoside inhibitors inhibit the RdRp by binding an allosteric site in a noncompetitive fashion, which changes the biochemical activity of the polymerase. They have a low barrier of resistance. Beclabuvir, an indole derivative, binds the thumb I subdomain on the RdRp with potent activity but has reduced activity against HCV genotypes 2 and 6 infections. Dasabuvir, a benzothiadiazine derivative, binds the palm I site on the RdRp, causing changes to the active site and preventing transcription., Deleobuvir and radalbuvir are additional nonnucleoside inhibitors .
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What Is Hepatitis C Again
Hepatitis C is a liver infection caused by the hep C virusand the disease is quite common. Its the most common chronic blood-borne infection in the United States. According to the U.S. Department of Health and Human Services, anywhere from 2 million to 2.8 million Americans live with chronic hepatitis C. That number could be much higher, given that many people who have hep C are asymptomatic and unaware that they are even infected.
You cant catch it from kissing, holding hands, or even if someone sneezes in your face. Hep C is passed on when infected blood gets into your bloodstream, which can happen in different ways, but typicals modes of transmission are:
Sharing needles or sharing straws to snort drugs
Working in healthcare
Sharing razors, toothbrushes, or nail clippers with an infected person
Getting a body pierce or tattoo in an unsterile environment
Getting a blood transfusion or organ transplant before the virus was discovered in 1989, or prior to 1992, when blood wasnt as thoroughly screened
Being born to a mother who had hep C when she was pregnant
While 30% of people who have hep C clear the infection through their own immune system, 70% dont, and treatment is crucial. When its left to linger, hep C can lead to serious liver complications.
Nonstructural 5a Complex Inhibitors
The NS5A complex plays a role in HCV RNA replication regulation as well as viral assembly and packaging, and directly interacts with the RNA-dependent RNA polymerase . The exact antiviral action of NS5A inhibitors is unknown they are theorized to inhibit hyperphosphorylation of the NS5A protein and alter the proteins location from the endoplasmic reticulum, likely causing faulty HCV assembly. Ledipasvir, ombitasvir, daclatasvir , elbasvir, velpatasvir, odalasvir, samatasvir, ravidasvir, ruzasvir, and pibrentasvir currently make up the class of NS5A inhibitors . Ledipasvir is one of the most potent inhibitors of the NS5A complex, but may have lower activity in HCV genotypes 2 and 3 infections.,, Ombitasvir is approved in combination with paritaprevir, ritonavir, and dasabuvir as part of the 3D regimen for the treatment of HCV genotypes 1 and 4 infections, but also has a higher pill burden, which could affect compliance. Velpatasvir has antiviral activity against HCV replicons in genotypes 1 through 6. NS5A complex inhibitors have high potency, multigenotypic coverage, and generally a low barrier to resistance. Newer agents in this class have the promise to increase the resistance threshold.
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What Happens If Hep C Meds Dont Work
In rare cases , the body wont respond to either medication. If this happens, your doctor may prescribe a more potent combination of antivirals such as those found in Vosevi.
This medication blends three anti-viral meds: sofosbuvir, velpatasvir, and voxilaprevir. Because its more powerful, it may have a higher burden of side effects like headache, fatigue, diarrhea, and nausea.
Dosage entails one pill taken once a day with food for 12 weeks. Your doctor may also keep you on the meds longer to clear the infection.
Fda Oks New Drug To Treat All Forms Of Hepatitis C
Associated PressAug. 4, 2017
U.S. regulators have approved the first drug to treat all forms of hepatitis C in as little as eight weeks.
The pill combination from AbbVie was approved Thursday by the Food and Drug Administration for adults without significant cirrhosis, a type of liver disease, and many patients who were not cured by prior treatment.
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Why Are The New Hepatitis C Treatments Better
The new treatments are highly effective with a cure rate of 95-97 per cent. Treatment time is reduced to 12 weeks, drugs are tablets and there are very few side effects.
This is a major change from just a few years ago, when hepatitis C treatment time was from six to twelve months, with toxic side effects, and only a 50 percent chance of being cured.
This means that people newly diagnosed with hepatitis C, as well as those who have been living with chronic hepatitis C for many years, will now have access to a fast, effective and well-tolerated cure.
Hepatitis C: New Treatments Emerge In 2014 That Will Have Profound Implications For Payers
Groundbreaking hepatitis C therapies represent a new era in treatment. But their cost is unprecedented, meaning health plans and PBMs are facing difficult formulary decisions.
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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The New Drugs Directly Target The Hepatitis C Virus
Older hep C medications were less effective at eliminating the infection from the body because they didnt impact the virus itself. Instead, they boosted the immune systems ability to clear the virus, explains Dr. Reau. That was also why they caused more side effects in general.
Thats all changed. The new antiviral medications directly target the virus and kill its ability to replicate, says Reau, allowing the body to effectively clear the residual bits and pieces of the virus.
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.
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Incomplete Or Failed Response To Treatment
Some people with autoimmune hepatitis have an incomplete response to treatment, meaning that treatment helps but does not lead to remission. If you have an incomplete response to treatment, you may need to take different medicines to help prevent liver damage.
Some people may fail to respond to treatment, meaning that the inflammation and liver damage of autoimmune hepatitis keep getting worse. Your doctor may recommend additional blood tests and higher doses of medicines. If liver damage leads to complications, you may need treatment for complications.
How Do You Treat Hepatitis C
Treatment for hep C has come a long way. Patients used to require weekly interferon injections that required a course of six months to a year. Now, meds are in the form of a tablet thats taken over just a few weeks. Better yet, 80% of patients taking hep C meds report no side effects. Those who do experience them say theyre extremely mild and can be managed with OTC medications.
The beauty of todays treatments is that they can cure even chronic hep C cases that have been around for decades. Though these meds can eliminate the virus from a patients system, they cant cure damage already done to the liver or reverse liver cancerthose more serious complications will often require a separate course of treatment.
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How Much Will It Cost Patients To Access The New Drugs
The Pharmaceutical Benefits Scheme listing means that hepatitis C patients will only pay the normal co-payment for the new drugs. The co-payment is currently worth $6.20 for patients with concessional healthcare cards and $38.30 for general patients without concessional healthcare cards, per drug, per month. For some patients needing three drugs, for example, the co-payment will therefore be $114.90 per month, or $18.60 per month concession.
More information on co-payment charges can be found on the Commonwealth Department of Healths website
A Promise Of A Cure With A Cost
These new medicines are expensive. Researchers believe that as more come to the marketplace, prices will drop to stay competitive. If you have life-threatening liver damage due to the hepatitis C virus, you might be eligible for “compassionate care” rates, which can greatly reduce your out-of-pocket cost. Ask your doctor or case manager or directly contact the drug manufacturers.
Remember, there is no one-size-fits all treatment for chronic hepatitis C. Which medication is best for you depends on many things, including:
- The amount of liver damage
- Your previous treatments
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What Can People Do To Help The Medications Work Best
- Take the medications every day
- Stay in touch with pharmacy to be sure that all refills are ready on time
- Take the medications exactly as prescribed
- Do not skip doses
- Get all blood tests done on time
- Go to all visits with providers as recommended
- Tell the provider about all other medications that are being taken – including over-the-counter medicines, vitamins, herbs, and supplements
- Complete the entire course of medication
What Are Genotypes And Do They Matter
Six different genotypes of hepatitis C have been identified. Genotypes 1 and 3 are the most common causes of hepatitis C in Australia and make up 90 per cent of all cases. They are important because they help determine the treatment you need. Unlike in the past, however, your genotype is not important in terms of the chance of cure. With the treatment drugs, all six genotypes have a very high chance of cure.
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Is Hep C Curable
The latest drugs available for hepatitis C have high success rates when it comes to curing the condition.
In conversations with your doctor, you can discuss the full range of treatment options. Some of these are combination drugs.
But its important to note that not every medication may be effective for you, even if its for the right genotype.
Another Potential Curative Drug For People With Chronic Hepatitis C Will Be Made Available On The Nhs
New draft guidance published today from NICE recommends elbasvir-grazoprevir – one of the newer hepatitis C antiviral drugs that can offer patients more effective treatment.
In clinical trials, elbasvir-grazoprevir showed cure rates above 90% for people with genotypes 1 and 4. The cure rate is dependent on the genotype, treatment history and presence of liver damage.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said:Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment.
Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin.
A 12-week course of treatment with elbasvir-grazoprevir usually costs £36,500 per patient, but the NHS will pay less than this as the company has offered a confidential discount.
Taken once daily, the tablet could treat around 4,000 patients in the first year, alongside other options already available for hepatitis C.
Professor Longson continued:Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced.
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How Is Hepatitis C Treated
Hepatitis C virus is treated with all-oral medications. These pills, calledantiviral medications, are usually taken once per day. These antiviral medications are extremely good at attacking the virus and preventing it from multiplying.
Antiviral medications were not the original treatment for hepatitis C. Before 2014, the only treatment for hepatitis C was called interferon and ribavirin, taken as weekly injections under the skin, plus pills. Interferon treatment caused many unpleasant side effects and was not usually successful. Then a new generation of medications became available. These antiviral treatments are extremely successful at curing the virus and have very minimal side effects.
Ribavirin is still sometimes prescribed to be taken along with the new antiviral medicines, but it has become more and more uncommon that ribavirin is needed at all. Ribavirin has some mild-moderate side effects. Ribavirin is a pill taken twice per day, as 2 or 3 pills in the morning plus 2 or 3 pills at night, depending on the patient’s body weight. Most patients do not need ribavirin.