Newest treatment for hepatitis c. Revolutionary Treatments for Hepatitis C: Exploring the Latest FDA-Approved Medications

26.06.202310.06.2023 by alexxlab

What are the newest drugs for treating hepatitis C. How do these medications work to combat the virus. Which hepatitis C genotypes can be treated with the latest approved drugs. What are the advantages of the newest hepatitis C treatments over older options.

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The Evolution of Hepatitis C Treatment: A New Era in Antiviral Therapy

Hepatitis C treatment has undergone a remarkable transformation in recent years. The introduction of direct-acting antivirals (DAAs) has revolutionized the landscape of hepatitis C therapy, offering patients more effective and better-tolerated treatment options. These innovative medications target specific steps in the hepatitis C virus (HCV) life cycle, leading to higher cure rates and shorter treatment durations compared to older interferon-based regimens.

The latest FDA-approved drugs for hepatitis C represent the cutting edge of antiviral therapy. These medications have demonstrated impressive efficacy across multiple HCV genotypes, often achieving sustained virologic response (SVR) rates exceeding 95%. This means that the vast majority of patients treated with these newer drugs can expect to be cured of their hepatitis C infection.

Mavyret: A Versatile Pan-Genotypic Treatment Option

Mavyret (glecaprevir/pibrentasvir) stands out as one of the most versatile new treatments for hepatitis C. This combination medication, approved by the FDA in 2017, offers several advantages:

Pan-genotypic activity: Effective against all six major HCV genotypes
Short treatment duration: Most patients require only 8 weeks of therapy
High barrier to resistance: Effective in patients with certain prior treatment experience
Broad patient population: Approved for adults and children as young as 3 years old

How does Mavyret work to combat hepatitis C? The medication combines two potent antiviral agents:

Glecaprevir: An NS3/4A protease inhibitor that blocks viral replication
Pibrentasvir: An NS5A inhibitor that interferes with viral assembly and release

This dual mechanism of action allows Mavyret to effectively suppress HCV replication and clear the virus from the body. The drug’s efficacy in treating all HCV genotypes makes it a valuable first-line option for many patients, simplifying treatment decisions for healthcare providers.

Vosevi: A Powerful Salvage Therapy for Difficult-to-Treat Cases

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) represents another significant advance in hepatitis C treatment. Approved by the FDA in 2017, Vosevi is primarily used as a rescue therapy for patients who have failed previous DAA-based treatments. Key features of Vosevi include:

Triple combination therapy: Incorporates three potent antiviral agents
High efficacy in treatment-experienced patients: Effective against HCV with resistance-associated substitutions
Pan-genotypic activity: Treats all six major HCV genotypes
Once-daily dosing: Simplifies treatment adherence

The components of Vosevi work synergistically to combat hepatitis C:

Sofosbuvir: A nucleotide analog NS5B polymerase inhibitor that blocks viral replication
Velpatasvir: An NS5A inhibitor that interferes with viral assembly and release
Voxilaprevir: An NS3/4A protease inhibitor that inhibits viral protein processing

By targeting multiple steps in the HCV life cycle, Vosevi can overcome resistance mechanisms that may have developed during previous treatment attempts. This makes it an invaluable option for patients with limited treatment alternatives.

Epclusa: Expanding Treatment Options for Patients with Decompensated Cirrhosis

Epclusa (sofosbuvir/velpatasvir) has emerged as a crucial treatment option for hepatitis C patients, particularly those with advanced liver disease. FDA-approved in 2016, Epclusa offers several notable advantages:

Pan-genotypic activity: Effective against all six major HCV genotypes
Once-daily, single-tablet regimen: Simplifies treatment adherence
Approved for use in decompensated cirrhosis: Expands treatment options for patients with advanced liver disease
Broad age range: Approved for adults and children as young as 3 years old

How does Epclusa differ from other new hepatitis C treatments? Its unique features include:

Efficacy in decompensated cirrhosis: When combined with ribavirin, Epclusa can effectively treat patients with more advanced liver disease
Ribavirin-free option: For patients without cirrhosis or with compensated cirrhosis, Epclusa can be used without ribavirin, reducing potential side effects
High barrier to resistance: The combination of sofosbuvir and velpatasvir provides a robust defense against viral resistance

The approval of Epclusa for use in patients with decompensated cirrhosis represents a significant advancement, as these individuals often have limited treatment options and are at high risk for liver-related complications.

Comparative Efficacy: How Do the Newest Hepatitis C Treatments Stack Up?

When evaluating the latest hepatitis C treatments, it’s essential to consider their comparative efficacy across different patient populations and HCV genotypes. While all of the newest medications demonstrate high cure rates, some key differences emerge:

Pan-genotypic activity: Mavyret, Vosevi, and Epclusa are all effective against all six major HCV genotypes, simplifying treatment decisions
Treatment duration: Mavyret often allows for shorter treatment durations (8 weeks) compared to Vosevi and Epclusa (12 weeks) in many patient populations
Prior treatment experience: Vosevi excels in treating patients who have failed previous DAA-based therapies
Cirrhosis status: Epclusa stands out for its approved use in patients with decompensated cirrhosis when combined with ribavirin

How do these newer treatments compare to older hepatitis C medications? The advantages of the latest drugs include:

Higher cure rates: SVR rates often exceeding 95% across genotypes
Shorter treatment durations: 8-12 weeks compared to 24-48 weeks with older interferon-based regimens
Improved tolerability: Fewer side effects and better quality of life during treatment
Simplified regimens: Once-daily dosing and fewer pills improve adherence

These advancements have transformed hepatitis C from a chronic, often progressive disease to a curable infection for the vast majority of patients.

Safety Profiles and Potential Side Effects of New Hepatitis C Medications

While the newest hepatitis C treatments offer significant improvements in efficacy and tolerability, it’s crucial to understand their safety profiles and potential side effects. How do these medications compare in terms of adverse events?

Mavyret: Generally well-tolerated, with headache and fatigue being the most common side effects
Vosevi: Common side effects include headache, fatigue, diarrhea, and nausea
Epclusa: Headache and fatigue are the most frequently reported adverse events

Are there any serious safety concerns with these new hepatitis C treatments? While rare, some important considerations include:

Hepatitis B reactivation: Patients with current or prior HBV infection should be monitored for potential HBV reactivation during and after DAA therapy
Drug interactions: DAAs may interact with other medications, particularly those metabolized by the liver
Use in specific populations: Dosing adjustments or additional monitoring may be necessary for patients with severe renal impairment or those taking certain concomitant medications

Overall, the safety profiles of these newer hepatitis C treatments represent a significant improvement over older interferon-based regimens, which were associated with more frequent and severe side effects.

Patient Selection and Individualized Treatment Approaches

With multiple highly effective treatment options now available, selecting the most appropriate regimen for each patient has become increasingly important. What factors do healthcare providers consider when choosing a hepatitis C treatment?

HCV genotype: While the newest treatments are pan-genotypic, some regimens may be preferred for specific genotypes
Prior treatment history: Patients who have failed previous therapies may require specific treatment approaches
Cirrhosis status: The presence and severity of cirrhosis can influence treatment selection
Comorbidities: Other medical conditions and potential drug interactions must be considered
Patient preferences: Factors such as pill burden, treatment duration, and cost may impact treatment adherence and success

How do these considerations translate into individualized treatment approaches? Some examples include:

Treatment-naÃ¯ve patients without cirrhosis: Mavyret for 8 weeks is often the preferred first-line option
Patients with decompensated cirrhosis: Epclusa plus ribavirin for 12 weeks is typically recommended
DAA-experienced patients: Vosevi for 12 weeks is often the treatment of choice
Patients with severe renal impairment: Mavyret may be preferred due to its minimal renal elimination

By carefully considering these factors, healthcare providers can optimize treatment outcomes and minimize the risk of treatment failure or adverse events.

The Future of Hepatitis C Treatment: Emerging Therapies and Research Directions

While current hepatitis C treatments offer high cure rates and improved tolerability, research continues to push the boundaries of antiviral therapy. What are some of the emerging trends and potential future developments in hepatitis C treatment?

Shorter treatment durations: Researchers are exploring ultra-short treatment courses (4-6 weeks) for certain patient populations
Novel drug combinations: New DAA combinations are being investigated to further improve efficacy and reduce the potential for resistance
Simplified treatment algorithms: Efforts are underway to develop pan-genotypic, ribavirin-free regimens suitable for all patient populations
Improved access and affordability: Research into more cost-effective treatment options and generic formulations continues

What potential breakthroughs may shape the future of hepatitis C treatment? Some areas of active research include:

Host-targeting agents: Drugs that modulate the host immune response to HCV infection
Long-acting formulations: Injectable or implantable medications that could provide sustained antiviral activity over extended periods
Combination therapies with immunomodulators: Exploring synergistic effects between DAAs and immune-based therapies
Preventive vaccines: Ongoing efforts to develop an effective hepatitis C vaccine to prevent initial infection

As research progresses, the goal remains to further simplify treatment regimens, improve outcomes for difficult-to-treat populations, and ultimately work towards the global elimination of hepatitis C as a public health threat.

What are the new drugs for the treatment of hepatitis C?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Feb 23, 2022.

The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), and Epclusa (sofosbuvir and velpatasvir).

Mavyret, Vosevi, and Epclusa are all FDA-approved for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).

Mavyret is used to treat patients 3 years of age and older. Mavyret is also approved for patients 3 years and older with HCV genotype 1 infection, who have previously been treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

Vosevi is indicated for use in the treatment of adult patients. It is used as a re-treatment option in patients who have been previously treated with an NS5A inhibitor-containing regimen (GT1-6), or a regimen containing sofosbuvir without an NS5A inhibitor (GT1a or GT3).

Epclusa is approved for use in adults and children 3 years of age and older. Epclusa is also approved in adults and children 3 years of age and older for the treatment of HCV genotype 1, 2, 3, 4, 5 or 6 in patients with decompensated cirrhosis (for use in combination with ribavirin).

Latest FDA Approvals for Hepatitis C

Drug	Type	Dosage Form	Company	Hepatitis C Indications	Patient Population
Mavyret (glecaprevir and pibrentasvir) FDA Approved 2017	glecaprevir NS3/4A protease inhibitor pibrentasvir NS5A inhibitor	tablets, pellets (children 3 to less than 12 years old weighing less than 45 kg)	AbbVie Inc.	genotypes 1,2,3,4,5,6	adults and children 3 years of age and older
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) FDA Approved 2017	sofosbuvir nucleotide analog NS5B polymerase inhibitor velpatasvir NS5A inhibitor voxilaprevir NS3/4A protease inhibitor	tablets	Gilead Sciences, Inc.	genotypes 1,2,3,4,5,6	adults
Epclusa (sofosbuvir and velpatasvir) FDA Approved 2016	sofosbuvir nucleotide analog NS5B polymerase inhibitor velpatasvir NS5A inhibitor	tablets; oral pellets (for children less than 6 years old)	Gilead Sciences, Inc.	genotypes 1,2,3,4,5,6	adults and children 3 years of age and older
Zepatier (elbasvir and grazoprevir) FDA Approved 2016	elbasvir NS5A inhibitor grazoprevir NS3/4A protease inhibitor	tablets	Merck	genotypes 1 or 4; is used with ribavirin in certain patient populations	adults and children 12 years of age and older or weighing at least 66 lb (30 kg)
Harvoni (ledipasvir and sofosbuvir) FDA Approved 2014	ledipasvir NS5A inhibitor sofosbuvir nucleotide analog NS5B polymerase inhibitor	tablets and oral pellets	Gilead Sciences, Inc.	genotypes 1, 4, 5 or 6; is used with ribavirin in certain patient populations	adults and children 3 years and older
Sovaldi (sofosbuvir) FDA Approved 2013	sofosbuvir nucleotide analog NS5B polymerase inhibitor	tablets and oral pellets	Gilead Sciences, Inc.	genotypes 1, 2, 3 or 4; must be given in combination with other antiviral medications (ribavirin; peginterferon alfa)	adults (type 1-4) and children 3 years and older (type 2-3)
Discontinued Products
Viekira XR, Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) FDA Approved 2016 (discontinued)	dasabuvir non-nucleoside NS5B palm polymerase inhibitor ombitasvir NS5A inhibitor paritaprevir NS3/4A protease inhibitor ritonavir CYP3A inhibitor	extended release tablets; tablets (co-packaged)	AbbVie Inc.	genotypes 1a or 1b	adults
Daklinza (daclatasvir) FDA Approved 2015 (discontinued)	daclatasvir NS5A inhibitor	tablets	BMS	genotypes 1 or 3	adults
Technivie (ombitasvir, paritaprevir, and ritonavir) FDA Approved 2015 (discontinued)	ombitasvir NS5A inhibitor paritaprevir NS3/4A protease inhibitor ritonavir CYP3A inhibitor	tablets	AbbVie Inc.	genotype 4	adults
Olysio (simeprevir) FDA Approved 2013 (discontinued)	simeprevir NS3/4A protease inhibitor	capsules	Janssen Pharmaceuticals, Inc.	genotypes 1 or 4	adults
Incivek (telaprevir) FDA Approved 2011 (discontinued)	telaprevir NS3/4A protease inhibitor	tablets	Vertex Pharmaceuticals Inc.	genotype 1	adults
Victrelis (boceprevir) FDA Approved 2011 (discontinued)	boceprevir NS3/4A protease inhibitor	capsules	Merck	genotype 1	adults

For more information, see Oral Hepatitis C Treatments: The Evolving Landscape

References

Zepatier prescribing information. Updated 12/2021. Merck. Whitehouse Station, NJ. Drugs@FDA. Accessed Feb. 23, 2022 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208261s007lbl.pdf

Mavyret (glecaprevir and pibrentasvir) [product information]. AbbVie Inc., North Chicago, IL. Accessed Sept. 10, 2021 at https://www.rxabbvie.com/pdf/mavyret_pi.pdf

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) [product information]. Gilead Sciences Inc., Foster City, CA. Updated 11/2019. Accessed Feb. 11, 2021 at https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/vosevi/vosevi_pi.pdf

Epclusa (sofosbuvir and velpatasvir). [product information]. Gilead Sciences Inc., Foster City, CA. Updated 07/2020. Accessed June 14, 2021 at https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf

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Medical Disclaimer

Hepatitis C Treatment Options

Written by Kelli Miller

Medically Reviewed by Neha Pathak, MD on October 26, 2022

How They Work
Today’s Meds

Hepatitis C is the No. 1 cause of liver cancer and liver transplants. It’s brought on by a virus you can catch if you come into contact with contaminated blood. You could get it from an unclean tattoo needle, for example. Sometimes, it spreads during sex.

It’s curable. But curing it hasn’t always been easy or comfortable. For decades, you needed painful shots of a medicine called interferon and a pill called ribavirin. These drugs didn’t target the virus that made you sick. Instead, they amped up your immune system so you’d fight it the way you do when you get the flu.

But the treatment didn’t always get the virus out of your body. Cure rates hovered around 50%. And people who stuck with the yearlong treatment — not all did — had to live with chemo-like side effects.

These days, more and more people can get rid of the virus by simply taking a pill, at home, for just a few weeks. There are several ways to do it without having to get shots.

Here’s a closer look at some of the drugs and a peek at those on the horizon.

There’s no one-size-fits-all option. There are many different types, or “genotypes,” of hepatitis C. Type 1 is the most common. This is important to understand when you talk to your doctor. Not all meds work on all types. Which medicine is best for you also depends on how much liver scarring (cirrhosis) you have.

Your doctor might call these new drugs direct-acting antivirals. They zoom in on the virus that’s making you sick. Each drug works in a slightly different way. But in general, the medicine interferes with proteins that help the virus grow or spread.

Most of the time, these meds remove all traces of the virus from your blood within 12 weeks. This is called sustained virologic response (SVR), and it’s what doctors look for to tell if you’re cured. How long you’ll need treatment can vary. It may range from 8 to 24 weeks.

Research is moving rapidly on treatments for hep C. As a result, what doctors will recommend for each case may change. Researchers may continue to come up with new treatments, and some of the combinations of medications below may change as they make new discoveries.

As always, it’s best to discuss your treatment options with your medical team.

Daclatasvir (Daklinza): Approval of this drug meant no more shots for the 1 in 10 people infected with hepatitis C virus (HCV) types 1 and 3. You take this pill once a day with sofosbuvir (Sovaldi). You might get a headache or feel a little tired. Tell your doctor if you feel super-sluggish. The FDA warns it can sometimes seriously slow your heart rate, which may require you to get a pacemaker.

Elbasvir and grazoprevir (Zepatier): This once-a-day pill treats HCV types 1 and 4. It may also offer new hope for people with hep C who also have cirrhosis, HIV, late-stage kidney disease, and other hard-to-treat conditions. Like the other antivirals, the side effects are mild. You might have a slight headache or bellyache, or you might feel tired.

Glecaprevir and pibrentasvir (Mavyret): Three pills daily can treat all types of hep C. Side effects are mild and can include headache, fatigue, diarrhea, and nausea.

Ledipasvir and sofosbuvir (Harvoni): This once-a-day pill launched a revolution in hep C treatment. It was the first interferon-free med for people with type 1. A year later, the FDA also gave the thumbs up for people with HCV types 4, 5, and 6 to use it. Side effects are mild. You might feel tired or have a slight headache. Some people have a bellyache, diarrhea, and trouble sleeping.

Ombitasvir, paritaprevir, and ritonavir, with dasabuvir (Viekira Pak):Doctors say this treatment works well for people with HCV type 1. You can even take it if you have some liver scarring, as long as your liver still can do its job. Your doctor might call this compensated cirrhosis. You take two pills once a day and another pill twice a day.

Some people find this clunky, but others say it beats getting shots. Side effects include feeling itchy, weak, tired, or having trouble sleeping. This medicine might cause severe liver damage in people with advanced cirrhosis.

Simeprevir (Olysio)and sofosbuvir (Sovaldi):The FDA said these two drugs could be given together to treat people with HCV type 1. Before that, you had to take the pills with interferon or ribavirin. Sofosbuvir can cause fatigue, headache, and tummy troubles and make it hard for you to sleep. Simeprevir may cause dry skin and a rash and make you more sensitive to sunlight.

Sofosbuvir and velpatasvir(Epclusa):This can treat all types of hep C with a single tablet. Common side effects are headache and fatigue. There are certain drugs that shouldn’t be taken with it, as the combination can slow your heartbeat. As always, check with your doctor.

Sofosbuvir, velpatasvir, and voxilaprevir (Vosevi):This can also treat all types of hep C with one tablet that you take each day. Typically, your doctor will only prescribe this if you don’t have cirrhosis and after other treatments have not worked. The most common side effects are headache, tiredness, diarrhea, and nausea.

Top Picks

The latest drugs for the treatment of hepatitis C

Standard therapy with interferon and ribavirin has made it possible over the past 10 years to save a huge number of patients with viral hepatitis C from severe complications – cirrhosis and liver cancer. This therapy made it possible to declare viral hepatitis C CURED DISEASE, however, under the condition of timely treatment and the absence of drug resistance in the virus (patients who do not respond to therapy).

In general, approximately 50% of patients with genotype 1 virus could expect a complete recovery with a course of treatment of 48 weeks, and 70-90% with genotypes 2 and 3 with a course of treatment of 24 weeks. With unsuccessful treatment, the course of therapy could be extended up to 72 weeks.

A large number of side effects and a deterioration in the quality of life during treatment significantly limited the possibility of obtaining a result, required constant monitoring and correction of treatment from the doctor, up to canceling therapy or prescribing additional expensive drugs.

Recent discoveries in molecular cell biology of the four structural and non-structural proteins and the Hepatitis C virus RNA specific structure (IRES), as well as host factors on which the hepatitis C virus is dependent, have led to the development of a new generation of direct antiviral agents. They are directed precisely at these targets and suppress the activity of the virus with high efficiency.

Clinical practice includes NS3/4A protease inhibitors such as telaprevir, boceprevir, and the latest generation drugs simeprevir
and sofosbuvir. These nucleoside analogs are used in combination with standard therapy with pegylated interferon and ribavirin (triple therapy). Triple therapy can significantly increase the effectiveness of treatment, especially in groups of patients who are difficult to treat.

However, the efficacy of triple therapy is significantly limited in patients who have previously failed treatment with peginterferon and ribavirin, as well as the inability of a large number of patients to complete the course of therapy due to serious side effects of interfron.

The first step in interferon-free therapy for patients with genotype 2 is the introduction of the recently approved combination of the nucleoside analog sofosbuvir plus ribavirin.

The first clinical trials of sofosbuvir in combination with and without ribavirin with genotype 1 showed high efficiency in obtaining a sustained virological response in patients of different groups:

– never received antiviral therapy;

– not responding to antiviral therapy;

– with relapse after successful AVT;

– with compensated liver cirrhosis, who received and did not receive AVT.

In all groups, as a result of 12 (or 24) weeks of therapy, results from 94 to 100% sustained virological response were obtained. Side effects were minor (fatigue, headache) and discontinuation of therapy did not occur in any patient in the group without ribavirin.

There was no relapse or virological breakthrough in any of the groups.

MEDICAL SCIENCE HAS NEVER BEEN SO CLOSE TO THE COMPLETE DESTRUCTION OF THE HEPATITIS C VIRUS.

THE ADVANCES OF PHARMACEUTICAL SCIENCE HAVE NEVER REACHED SUCH PROMISING RESULTS:

“THE NEXT GENERATION OF PEOPLE WILL LIVE WITHOUT VIRAL HEPATITIS C.” /M.R.MANNS/

Important to know!

What are the causes of hepatic steatosis?
What is hepatic steatosis?
What is liver fibroscan?
How is hepatitis C transmitted?

American scientists have developed a cure for hepatitis C

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24 April

American scientists have developed a cure for hepatitis C, which has successfully passed the second phase of clinical trials, showing its effectiveness among patients.

Hepatitis C is a viral disease that affects the liver, which can lead to cirrhosis and, as a result, death. This disease is treatable, but the drugs currently used do not work for all patients and, in addition, cause many side effects. There are six types of hepatitis C virus. The most common genotype of the virus in the United States, Europe and Russia – the first – cannot be cured in a significant proportion of patients.

Scientists from the University of Texas at San Antonio have developed a drug that suppresses the reproduction of the virus. It is a combination of sofosbuvir and ledipasvir. Of the three standard phases of clinical trials, the drug has already passed the first (for safety and side effects) and the second phase (testing the drug for efficacy).

To test the drug for effectiveness, scientists selected 100 volunteers diagnosed with hepatitis C of the first genotype: both those who were not treated and those who were treated, but unsuccessfully. For 12 weeks, the subjects, divided into five groups, took a tablet with a combination of sofosbuvir and ledipasvir. In one group, ribavirin, the standard drug used to treat hepatitis C, was added to this combination.

As a result of the experiment, 97% of the participants had a sustained virological response – the elimination of the hepatitis C virus from the body. However, scientists are in no hurry to introduce the drug into treatment programs. Further clinical trials are required to determine the exact dose of the drug, as well as the contribution of ribavirin to treatment.

Based on materials from ria.ru

IMPORTANT!

The information in this section should not be used for self-diagnosis or self-treatment. In case of pain or other exacerbation of the disease, only the attending physician should prescribe diagnostic tests. For diagnosis and proper treatment, you should contact your doctor.
For a correct assessment of the results of your analyzes over time, it is preferable to do studies in the same laboratory, since different laboratories may use different research methods and units of measurement to perform the same analyzes.

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