Treatment FAQ

why does it take so long to be approved hcv treatment

by Mr. Francis Denesik Published 2 years ago Updated 2 years ago

How long does HCV treatment take?

Treatment is usually 8-12 weeks long but can be as much as 16 weeks long in certain situations. Some patients with more damage to their liver may require 24 weeks of treatment, but this is uncommon. The duration depends on the medication, and specific HCV factors in particular patients.

How long does it take to get HCV results?

Antibodies are chemicals released into the bloodstream when someone gets infected. Test results can take anywhere from a few days to a few weeks to come back. Rapid anti-HCV tests are available in some health clinics and the results of these tests are available in 20 to 30 minutes.

What is the newest treatment for hep C?

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 (Harvoni); sofosbuvir (Sovaldi); daclatasvir (Daklinza); and ribavirin (Ibavyr).

Is 8 12 weeks a cure for hep C?

Clinical trials involving about 2300 adults with any of the 6 HCV genotypes showed that 92% or more who received the combination for 8, 12, or 16 weeks had no detectable virus in their blood 12 weeks after treatment ended, suggesting their infections were cured.

How long does it take for Hep C to cause liver damage?

After many years some people will have minimal liver damage with no scarring while others can progress to cirrhosis (extensive scarring of the liver) within less than ten years. On average it takes about twenty years for significant liver scarring to develop.

Can Hep C come back after treatment?

It's possible, but rare, for hepatitis C infection to reappear after apparently successful treatment. Relapses usually occur in the first few months after blood testing to confirm that the virus is no longer detectable. Sometimes, however, a relapse becomes evident much later.

What is the 8 week treatment for hep C?

The FDA expanded approval of a hepatitis C drug that shortens treatment time to eight weeks. AbbVie's Mavyret tablets treat compensated cirrhosis in patients with chronic hepatitis C who weigh at least 99 pounds. Before approval of this drug, the standard treatment time was at least 12 weeks.

What happens after hep C is cured?

After you clear your hep C (being cured) you won't have any immunity to protect you from catching it again. You can lower your risk of catching hep C again by avoiding blood-to-blood contact with other people.

Can chronic hep C be cured?

Today, chronic HCV is usually curable with oral medications taken every day for two to six months. Still, about half of people with HCV don't know they're infected, mainly because they have no symptoms, which can take decades to appear.

How long can you live without hep C treatment?

Like the human papillomavirus (HPV), early acute hepatitis C can clear on its own without treatment; this happens about 25% of the time. However, it's more likely that the virus will remain in your body longer than six months, at which point it's considered to be chronic hepatitis C infection.

Does hep C treatment make you sick?

Treatment for hepatitis C keeps changing quickly. The standard treatment was typically interferon along with other drugs -- usually ribavirin and either boceprevir (Victrelis) or telaprevir (Incivek). But many people have a hard time with interferon's side effects, which include fatigue, fever, chills, and depression.

What is the best treatment for hep C?

Hepatitis C is treated using direct-acting antiviral (DAA) tablets. DAA tablets are the safest and most effective medicines for treating hepatitis C. They're highly effective at clearing the infection in more than 90% of people.

What is the aseptic technique for HCV?

All health-care personnel, including those who are HCV positive, should follow a strict aseptic technique as described by the National Institute for Occupational Safety and Health and the CDC, including appropriate hand hygiene, use of protective barriers, and safe injection practices.

How long does it take for antibodies to show up in a blood test?

The window period for acute HCV infection before the detection of antibodies averages 8 to 11 weeks, with a reported range of 2 weeks to 6 months.

How rare is hepatitis C?

Now that more advanced screening tests for hepatitis C are used in blood banks, the risk of transmission to recipients of blood or blood products is considered extremely rare, at <1 case per 2 million units transfused.

What is the risk of cirrhosis in the following year?

Patients who develop cirrhosis have a 1%–4% annual risk of developing hepatocellular carcinoma and a 3%–6% annual risk of hepatic decompensation; for the latter patients, the risk of death in the following year is 15%–20% ( 7 ).

Can hepatitis C cause liver enzymes to fluctuate?

Yes. It is common for patients with chronic hepatitis C to have fluctuating liver enzyme levels, with periodic returns to normal or near normal levels. Liver enzyme levels can remain normal for over a year despite chronic liver disease ( 28 ).

Can HIV be transmitted through sex?

Although less frequent, HCV can also be spread through: Sex with an HCV -infected person (an inefficient means of transmission, although HIV-infected men who have sex with men [MSM] have increased risk of sexual transmission) Sharing personal items contaminated with infectious blood, such as razors or toothbrushes.

Does dental surgery spread hepatitis C?

As long as Standard Precautions and other infection-control practices are consistently implemented, medical and dental procedures performed in the United States generally do not pose a risk for the spread of hepatitis C.

How does hepatitis C therapy help?

Proper adherence to Hepatitis C therapy will increase your chance of being cured and decrease the long-term complications of Hepatitis C. Adhering to other aspects of your treatment plan is also important.

What to do if you think you have hepatitis C?

If you think you are at risk of having Hepatitis C, talk to your current healthcare provider about getting tested. Once you’ve been diagnosed with Hepatitis C infection, you may want to see a specialist. Specialists who work with people with Hepatitis C include the following healthcare providers:

Why is it important to adhere to your treatment plan?

Once you begin treatment for your Hepatitis C infection, you’ll want to do everything you can to make it a success. Adherence to your Hepatitis C medication regimen is an important predictor of successful treatment.

Can hepatitis C be detected again?

Relapse: The Hepatitis C virus becomes undetectable on treatment, but then is detectable again, either during treatment or after treatment is stopped. Incomplete treatment: Treatment ended earlier that the prescribed duration. The goal of treatment is to have an SVR. This is when you are considered cured.

Can hepatitis C be too high?

Some medicines interact with Hepatitis C medications, which can affect the level of either one – meaning that the level of the Hepatitis C medicine or your other medicine may become too high or too low. There can be risks of toxicity if too high, or the medication may be less effective if too low.

Can you take other medicines for hepatitis C?

Take other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. They may affect how well your hepatitis C treatment works, and your hepatitis C treatment may affect the way other medicines work.

Is it important to know about hepatitis C?

Many hepatitis C medications have important considerations that you should be aware of before starting a course of treatment for your HCV infection. Some considerations are specific to a particular drug, while others are more general in nature.

What are the different types of HCV drugs?

Classes of drugs to treat HCV 1 Nonstructural 3/4A protease inhibitors. Protease inhibitors block NS3/4A serine protease, inhibiting functional viral proteins from being created. 2 Nonstructural 5A complex inhibitors. Although the exact antiviral action of NS5A inhibitors is unclear, they are thought to cause faulty HCV assembly by inhibiting hyperphosphorylation of the NS5A protein and altering the protein's location from the endoplasmic reticulum. 3 Nonstructural 5B polymerase inhibitors. There are two distinct classes of these drugs: nucleos (t)ide inhibitors and nonnucleoside inhibitors. Nucleos (t)ide inhibitors are analogues that are incorporated into the viral RNA genome by RNA-dependent RNA polymerase (RdRp). This causes termination of further replication and competitively binds the active polymerase site. This class of NS5B polymerase inhibitors has a high barrier to resistance and works broadly against genotypes with intermediate potency. On the other hand, nonnucleoside inhibitors are small molecules that inhibit the RdRp by binding an allosteric site in a noncompetitive fashion, which changes the biochemical activity of the polymerase.

How many people in the world have HCV?

According to the World Health Organization, 130 million to 150 million people worldwide are infected with HCV, and this population is expected to increase by an average of 3 million to 4 million cases annually.

Can HCV go undetected?

Hepatitis C virus (HCV) infection can lead to cirrhosis and its related complications, hepatocellular carcinoma (HCC), liver failure and death. Once one of the leading indications for liver transplantation, HCV frequently goes undetected, mainly because it can take decades for symptoms to appear. In an article recently published in Gastroenterology and Hepatology, Mayo Clinic author Hugo E. Vargas, M.D., and co-author Jennifer L. Horsley-Silva, M.D., provided a comprehensive overview about HCV infection and treatment. Dr. Vargas addresses some of these issues in the questions and answers that follow.

How is hepatitis C transmitted?

Hepatitis C is transmitted from one person to another through blood-to-blood contact. Today, the most common routes of transmission include: 1 being born to a mother with hepatitis C 2 sharing needles or syringes that have been used to inject recreational drugs 3 being accidentally stuck with a used needle while working as a healthcare provider

How many people die from hepatitis C?

Without antiviral treatment, an estimated 67 to 91 percent of people with hepatitis C-related liver scarring die from liver cancer, liver failure, or other liver-related causes.

Is it safe to delay hepatitis C treatment?

It can take time for chronic hepatitis C to cause serious symptoms. But that doesn’t mean it’s safe to delay treatment. Starting treatment early may lower your risk of developing complications from the illness, including liver scarring and liver cancer.

What is one time hepatitis C testing?

One‑time hepatitis C testing regardless of age or setting prevalence among people with recognized conditions or exposures : People with HIV. People who ever injected drugs and shared needles, syringes, or other drug preparation equipment, including those who injected once or a few times many years ago. People with selected medical conditions, ...

What test should I take for hepatitis C?

Hepatitis C testing should be initiated with a Food and Drug Administration (FDA)‑approved anti‑HCV test. People testing anti‑HCV positive /reactive should have follow-up testing with an FDA‑approved nucleic acid test (NAT) for detection of HCV RNA.

When did people receive clotting factor concentrates?

people who received clotting factor concentrates produced before 1987. people who received a transfusion of blood or blood components before July 1992. people who received an organ transplant before July 1992. people who were notified that they received blood from a donor who later tested positive for HCV infection.

How many cases of HBV reactivation in DAA?

The U.S. Food and Drug Administration (FDA) issued a drug safety warning on October 4, 2016 in which they identified 24 cases of confirmed reactivation of HBV infection in persons receiving DAA medications for treatment of HCV. [ 18] The FDA warning was based on a number of cases reported to the FDA and from published literature. [ 19, 20, 21, 22, 23, 24] The FDA has published findings that summarized a total of 29 patients (5 from the United States) with confirmed HBV reactivation during DAA therapy; their summary was based on published reports and cases detected via their Adverse Event Reporting System database between November 2013 and October 2016. [ 25] The following summarizes key findings from this report:

Can you be immune to HCV if you have an SVR?

All patients who achieve an SVR should clearly understand they are not immune to HCV and can become reinfected with HCV. [ 15, 34, 35, 36] The AASLD-IDSA HCV Guidance stratifies the follow-up for persons who achieve an SVR based on the degree of hepatic fibrosis and the risk of HCV reinfection.

Can you take ribavirin with a negative pregnancy test?

Accordingly, ribavirin should not be started unless there is a documented report of a negative pregnancy test immediately prior to planned initiation of ribavirin.

How long does it take for hepatitis C to cure?

Hepatitis C infection is cured if the virus is undetectable 12 weeks after the completion of a course of direct-acting antiviral treatment. This is known as a sustained virologic response (SVR). Cure rates are very high; around 97% of people who start a course of treatment are cured and viral rebound after completing treatment is very rare.

What is sustained virologic response?

A sustained virologic response is associated with a reduction in fibrosis (liver scarring). Stopping viral replication stops inflammation in the liver and permits liver cells to be renewed. Although sustained virologic response is agreed by liver experts to signify that hepatitis C virus (HCV) infection has been cured, ...

Does hepatitis C remain in the body after treatment?

Does hepatitis C virus remain in the body after successful treatment? Persistence of very low-level hepatitis C infection after a sustained virologic response to hepatitis C treatment is an extremely rare event and is not associated with any liver damage, Spanish researchers report in Nature Scientific Reports this week.

Does hepatitis C show up in serum?

Hepatitis C virus was not detected in serum samples at any visit, but the participant did test positive for HCV antigenomic strand at the second visit. At subsequent visits HCV antigenomic strand was not detected.

Is viral persistence rare?

The investigators conclude that viral persistence after achieving sustained virologic response is a rare event, but evaluation of people who have achieved sustained virologic response using ultrasensitive tests may be warranted before organ and blood donation, and for women who wish to have children after being cured of hepatitis C .

How long does it take to cure hepatitis C?

Thanks to advances in medicine, hepatitis C can be fully cured in the vast majority of people within just eight to 12 weeks of treatment, according to the Centers for Disease Control and Prevention (CDC).

How long does it take for hepatitis C to go away?

If you experience symptoms of hepatitis C (and many people don’t), it may take a few weeks or months after you finish your treatment to feel better — if you notice any changes at all.

How to avoid getting re-infected with hepatitis C?

To avoid getting re-infected, it’s important to take all the steps you’d take to avoid the virus in the first place. For example, don’t share razors or syringes, and avoid sharing toothbrushes with people who’ve been diagnosed with hepatitis C. It’s also a good idea to ask your partner to be tested for hepatitis C.

Can you drink alcohol after hepatitis C?

You may not be able to keep drinking. For some people, it’s a good idea to avoid alcohol after you’ve been cured of chronic hepatitis C, mainly because adult beverages might tax your damaged liver and cause additional liver damage.

Can you live after hepatitis C treatment?

7 Things to Know About Life After Hepatitis C Treatment. Yes, the virus has been cleared from your body — but depending on whether you have liver damage, you may still need some additional follow-up appointments. Even if you've been cured of hepatitis C, you might need to take additional steps to protect your health.

Can over the counter medications cause liver failure?

Try to avoid over-the-counter medications and supplements. Some supplements, herbs, and over-the-counter drugs can cause liver damage and potentially even liver failure, Menon notes, particularly herbal remedies and body-building supplements.

Can you get hep C again?

You can still get hep C again. Hepatitis C is unlike many viruses you may be familiar with, since you can still become re-infected even after you’ve been cured. And, unfortunately, there is no vaccine on the horizon. “The antibody you get from hepatitis C is not protective,” says Menon.

Treatment

  • Hepatitis C virus is treated with all-oral medications. These pills, called antiviral 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 hepa…
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Medical uses

  • Ribavirin (without interferon) 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 n…
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Mechanism

  • 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 a viral load (also called HCV RNA).
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Symptoms

  • The medications will usually cause a very big drop in the viral load within the first two weeks. Some patients will see their viral load become undetectable very early, such as by the fourth week. For other patients, it can take longer until their viral load becomes undetectable.
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Results

  • 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.
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Access

  • For more about hepatitis C treatment, see our patient information , contact the Centers for Disease Control and Prevention (CDC) Hepatitis Toll-Free Information Line at 1-888-4 HEPCDC (1-888-443-7232), or visit the CDC website at http://www.cdc.gov/hepatitis/index.htm .
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