Thursday, June 16, 2022

Drugs Used To Treat Hepatitis C

How Many Victorians Are Affected By Hepatitis C And Who Is Affected

New and experimental oral drugs to treat hepatitis C.

Hepatitis C is the most common blood borne virus in Australia with approximately 230,000 people currently living with hepatitis C in Australia and around 65,000 in Victoria.

The population most at risk of acquiring hepatitis C are people who currently inject drugs including people from Aboriginal and Torres Strait Islander and culturally and linguistically diverse backgrounds, prisoners, older people, and young injectors and/or new initiates to injecting drug use.

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.

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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Helpful Tips While Taking Hepatitis C Medications

  • Always follow your health care providers’ advice, particularly the instructions on taking your medicine.
  • If you have to cancel an appointment, call your provider and schedule a new one as soon as possible.
  • Take good care of yourself. Eat well, drink 8 to 10 glasses of water each day, and try to get a full night’s sleep.
  • Learn about the hepatitis C medications you are taking. This includes special risks and warnings.
  • If taking ribavirin, use sunscreen, wear long sleeves and a hat, and limit sun exposure.
  • Write down your doctor’s name and phone number. Carry this information with you at all times.
  • Write the names and amounts of the medicines you are taking. Carry this information with you at all times.

Treatments For Hepatitis C

Harvoni Hepatitis C Drug Photograph by George Post

The goal of treatment is a virological cure . This is defined as undetectable viral RNA in plasma 24 weeks after treatment has finished. A sustained virological response prevents the development of cirrhosis. In patients who already have cirrhosis, a sustained virological response reduces the risks of liver failure and hepatocellular carcinoma.

The approved treatment combinations for hepatitis C in Australia are summarised in Tables 2 and 3. Currently, all PBS-subsidised regimens involve peginterferon plus ribavirin.

TABLE 3 TGA-approved interferon-free regimens for hepatitis C
Viral genotype

F0-3 METAVIR fibrosis stage 0-3

F4 METAVIR fibrosis stage 4

* Not listed on the Pharmaceutical Benefits Scheme at the time of writing.

Response rate was defined as proportion of patients with a sustained virological response measured at 3 or 6 months after the end of treatment.

8 weeks may be considered in treatment-naïve patients with no cirrhosis and a baseline viral RNA concentration < 6 x 106 IU/mL.

§ 24 weeks is recommended for patients who have failed treatment with peginterferon + ribavirin with or without a protease inhibitor.

# 24 weeks is recommended for patients who have had a previous null response to peginterferon + ribavirin, defined by a decrease in the viral RNA level of < 2 log10 IU/mL at week 12 or < 1 log10 IU/mL at week 4 during previous peginterferon + ribavirin treatment.

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Reducing Infections Among Injecting Drug Users

Among injecting drug users, the sharing of needles and syringes is the key risk factor for acquiring HCV infection, although there is considerable evidence of a potentially high risk of infection associated with sharing drug-preparation equipment such as cookers, filters, swabs and water . However, there is good evidence to show that retention in opioid substitution treatment reduces injection frequency , and that it is most effective in reducing HCV transmission when used alongside interventions that support safer injection practices . Two studies that examined the independent and combined effects of needle and syringe programmes and opioid substitution treatment on HCV incidence concluded that the combined effect of these two interventions resulted in the greatest reductions in HCV transmission .

Modelling studies have been used to explore the potential effectiveness of different hepatitis C interventions, and these indicate that it may be difficult for opioid substitution treatment and high-coverage needle and syringe programmes to greatly impact on hepatitis C prevalence. Modelling the scale-up of both interventions for the United Kingdom shows that they are unlikely to lead to substantial reductions in the prevalence of chronic hepatitis C after 10 years, unless both interventions cover 80% or more of the injecting population .

What Drugs Cure Hepatitis C Infection

    Most hepatitis C is currently treated with all-oral medical regimens of “direct-acting antivirals” or DAAs. DAAs is a term used to distinguish these hepatitis C drugs from an older generation of injected medicines that act indirectly on the immune response to the hepatitis C virus. DAAs act directly on the virus to block different steps in its life cycle. There are several DAAs that are used in combinations that have been scientifically proven to cure hepatitis C. They are not interchangeable, and some are only available combined in one pill or dose pack as a specific combination. DAAs are not used as single-drug therapy because of the high risk of the virus developing resistance and because they work best in combinations. The choice of which regimen to use depends upon the genotype of the virus, the level of liver fibrosis , and any drug resistancethat may be present .

    Examples of combination DAAs with cure rates between 91%-100% include:

    • Harvoni
    • Zepatier
    • Mavyret

    Genotype 1a and 1b are the commonest genotypes in the United States. Of all the genotypes, genotype 3 has been the most difficult to treat with DAAs alone and required the use of ribavirin, which has significant side effects. All genotypes can now be treated with oral DAAs without ribavirin. Some genotypes may still require the use of injected pegylated interferon and/or ribavirin if there is no response to DAAs.

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      How Much Does Hepatitis C Treatment Cost

        It is impossible to say what the exact cost is for the various regimens, but it is in the tens of thousands of dollars. In general, out of pocket cost would be very high for the average person, and most people are treated through a health insurer, federal health benefits, or veteran’s benefits. The cost of hepatitis C and the care of its complications, however, is much higher over a person’s lifetime, and the roughly estimated savings is believed to make treatment a good health and financial investment. Liver transplantation alone may cost several hundred thousand dollars for the procedure alone, followed by several hundred thousand for the medications needed in the first 6 months afterward.2 This does not include the many complications of liver transplantation.

        Because negotiations are confidential business contracts, little is known about how much is actually paid for medical treatments by these drugs. One example is the medication sofosbuvir. Estimated costs for a standard 12-week treatment with sosobuvir was $84,000 in the US. Actual costs to individuals depend upon price contracts between pharmaceutical companies and health insurers, as well as government and private organizations. Thus, an individual with healthcare coverage may only pay a monthly co-pay.4

        Direct Acting Antiviral Agents

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        This is the class of drugs acting against viral and host proteins involved in HCV life cycle. The major inhibitors of NS3 viral protein are telaprevir and boceprevir. Telaprevir was approved and recommended for use with PegIFN- and ribavirin in genotype-1 patients. This was classified as triple therapy. Since telaprevir treatment is reported to be effective against the resistant mutants in the short term duration, it was decided to use it for long-term and subsequently approved for the treatment. It is important to note here that the long term use of these drugs often leads to drug resistance including T54A/S, R155K/T, V36A/M, V55A, and A156/S/T/V, etc. Simeprevir is another NS3 protease inhibitor classified as second generation drug. This drug is a reversible inhibitor of NS3/4A protease. Danoprevir and faldaprevir are also second-generation HCV NS3/4A protease inhibitors and used in patients infected HCV genotype-1. In addition to these drugs, there are various other NS3 protease inhibitors like Vaniprevir , Narlaprevir , Asunaprevir , VX 985, and MK-5172 which are used for treatment of HCV infection. There is every possibility that these drugs may be approved for therapeutic use against HCV infection.

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        Preemptive Hcv Treatment Before Immunotherapy Or Chemotherapy

        Pregnancy

        The risk of vertical transmission in mothers with an HCV monoinfection is 5% and is not diminished by cesarean section. Mothers are not advised against breastfeeding either.

        There is an urgent indication for preemptive antiviral treatment in patients with a chronic hepatitis B infection before they undergo certain types of immunotherapy or chemotherapy . There is insufficient evidence at present for any recommendation of an analogous procedure for patients with chronic hepatitis C.

        More Pills On The Way

        Within the next year, the FDA should approve three or four drugs that can cure hepatitis C by mouth, not needle. And even more are expected in the next 2 years. Like Harvoni, all will combine two or more types of medicine in each pill.

        âIt’s a cocktail therapy – a number of drugs that target different viral proteins,â says virologist Stephen J. Polyak, PhD. He’s a research professor in the department of laboratory medicine at the University of Washington in Seattle. âThe harder that you can hit a virus and knock it down, hit it in multiple places, the more you can keep it suppressed.â

        Because the hepatitis C virus can mutate, one type of medicine can’t cure the disease on its own — two or more are needed.

        âThey all attack the virus in different sites,â Boyer says. âYou can’t give a single drug for hepatitis C it will just mutate and become resistant.â

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        How Will My Provider Monitor Me During The Treatment

        Your provider will meet with you during treatment to review how well you are tolerating treatment and review laboratory results. Laboratory tests help keep tabs on your health, track the viral load, and determine your response to treatment. You will be given specific dates to go get your blood tested at the lab during and after the treatment.

        The Treatment Of Acute Hepatitis C

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        Antiviral drugs

        The basis of current, interferon-free treatment is a combination of directly acting antiviral drugs with high antiviral efficacy, resistance barriers, and different sites of attack.

        In the multicenter German Acute HCV IV trial, six weeks of treatment with sofosbuvir/ledipasvir resulted in a sustained viral eradication rate of 100% in patients acutely infected with HCV genotype 1 . It should be noted, however, that the combination of sofosbuvir and ledipasvir is available in Germany only in packages of 28 tablets, so that taking a single tablet per day for six weeks is unreasonable in terms of drug economics. Until further data are available, patients with acute hepatitis C should be treated for eight weeks, analogously to the recommendations for previously untreated patients with acute hepatitis C. As the rate of HCV transmission to health care workers via needle stick injury is very low, no post-exposure prophylaxis is recommended in this situation .

        Polymerase inhibitors

        RNA-dependent RNA polymerase inhibitors are categorized as either nucleotide inhibitors or non-nucleoside inhibitors . The generic names of all HCV polymerase inhibitors end in -buvir.

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        What Are The Symptoms Of Hepatitis C

        Symptoms of Acute Hepatitis C Infection

        The majority of newly-infected patients identified with HCV do not have symptoms. The minority of patients who have symptoms typically have complaints of

        Symptoms of Chronic Hepatitis C Infection

        Chronic hepatitis C usually causes no symptoms until very late in the disease. Over the years or decades, chronic inflammation may cause scarring . Extensive scarring in the liver is called cirrhosis.

        Becoming infected with another viral hepatitis or other exposures that damage the liver in addition to hepatitis C can increase liver damage or even cause severe hepatitis. Having HIV infection along with HCV accelerates the progression of chronic hepatitis C to end-stage liver disease, sometimes shortening the course to a few years instead of decades.

        What About Patients With Hepatitis C Who Also Have Hepatitis B

        Hepatitis B virus can flare in patients who are co-infected with hepatitis B and hepatitis C and are taking medication for hepatitis C. This has been reported as a potential risk for patients who are taking hepatitis C treatment and have underlying hepatitis B as well. The flare usually occurs within a few weeks after the patient starts taking medication for hepatitis C. Therefore, patients who have both hepatitis B and hepatitis C should be seen by a hepatitis expertbeforestarting treatment of the hepatitis C they may need to start taking hepatitis B treatment to avoid a hepatitis B flare.

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        Which Medications Are Used To Treat Hep C

        In the last several years, treatment for hepatitis C has changed dramatically, thanks to a class of drugs known as direct-acting antivirals . These meds target and eliminate proteins found in the virus. Theyre much gentler on the body than the more intrusive treatments of the past. Patients have fewer side effects and shorter treatment timessome in just eight weeks.

        The two most common medications prescribed are Mavyret and Epclusa , both of which include a cocktail of several antiviral meds in one pill. While theyre equally effective in curing the virus, the one your doctor chooses may depend on other meds youre taking or on your insurance company.

        Proinflammatory Cytokines Induce Depression

        Study Looks At Treating Injection Drug Users For Hepatitis C

        Mercifully, for patients with hepatitis C, treatment with the cytokine interferon IFN-alpha has been supplanted by more effective and tolerable treatment options. But during the years of its clinical hegemony, IFN-alpha provided a unique model system for understanding behavioral and biological responses to chronic inflammation relevant to depression. Results from many studies have been quite consistent in demonstrating that IFN-alpha exposure produces a widespread increase in depressive and anxious symptoms, with a sizable minority of patients meeting full criteria for major depressive disorder within a month of commencing treatment. As reviewed in Miller and Raison , IFN-alpha treatment also produces all known biological changes associated with MDD more generally, including increased circulating pro-inflammatory cytokines, disruption of the diurnal cortisol rhythm and induction of glucocorticoid resistance, altered sleep physiology, and changes in monoamine metabolism, with many of these changes associating with increased depression during treatment . Supporting these findings are studies showing that even a single exposure to inflammatory stimuli induces depressive symptoms and depressive-style social cognitions in healthy volunteers, with these effects being strongest in women .

        Anton Pozniak, in, 2010

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        Antiviral Treatment In Pregnancy

        The risk of vertical transmission in mothers with an HCV monoinfection is 5% and is not diminished by cesarean section . Mothers are not advised against breastfeeding either. Vertically acquired hepatitis C takes a mild course in childhood, with very slow progression of hepatic fibrosis . Antiviral treatment during pregnancy cannot be recommended, as there are insufficient data on the potential teratogenicity of DAAs.

        How Effective Is Hepatitis C Medication

        Todays treatments are incredibly effective. According to the FDA, they have a 90-to-100% cure rate in just two to three months. A few months after your prescribed course of treatment is finished, your doctor will order a blood test to measure how much viral genetic material is in your blood. If none is visible, then youre considered cured. Note: These medications arent vaccines. There is no vaccine for hep C. While researchers continue to work on a vaccine in order to reach the World Health Organization’s goal of reducing infections by 80% in 2030, they have yet to be successful. So if you engage in risky behaviors, the condition could come back. It’s in your hands to live your life fully, safely!

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        Pregnancy And Hepatitis C

        The new hepatitis C medicines have not been tested in pregnancy.

        You should not become pregnant while taking treatment as it could be harmful to unborn babies.

        If you’re pregnant, you must delay treatment until after your baby is born.

        Speak to your doctor before starting hepatitis C treatment if you’re planning to become pregnant in the near future.

        You’ll need to wait several weeks after treatment has ended before trying to get pregnant.

        Women taking ribavirin should use contraception during treatment and for another 4 months after the end of treatment.

        Men taking ribavirin should use a condom during treatment and for another 7 months after the end of treatment. This is because semen can contain ribavirin.

        If you become pregnant during treatment, speak to your doctor as soon as possible to discuss your treatment options.

        What Are Genotypes And Do They Matter

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        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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