How long is harvoni treatment?

Today’s Meds

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.

Length of treatment

The standard length of treatment is 12 to 24 weeks, depending on genotype, viral load, liver condition and prior treatment experience and response. In some cases, 8 weeks may be considered in patients without cirrhosis who have pre-treatment HCV RNA (viral load count) less than 6 million IU/mL.

The treatment timeline will depend on your HCV-RNA (virus load count), SVR (sustained virologic response) meaning if the virus is detected in your blood over a period of time, your liver condition, and severity of side effects.

For treatment with Epclusa, Vosevi, or Mavyret; These treatments work for all genotypes 1-6:

Standard treatment time is 12 weeks.

For Genotype 1a:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Harvoni for 12 weeks**

or

Viekira Pak + Ribavirin for 12 weeks (w/o cirrhosis) or 24 weeks (with cirrhosis)

or

Daklinza for 12 weeks

or

Zepatier for 12 weeks

For Genotype 1b:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Harvoni for 12 weeks**

or

Viekira Pak for 12 weeks (w/o cirrhosis) or use with Ribavirin for 12 weeks (with cirrhosis)

or

Daklinza for 12 weeks

or

Zepatier for 12 weeks

For Genotype 2:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Sovaldi + Ribavirin for 12 to 16 weeks (with cirrhosis)

For Genotype 3:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Sovaldi + Ribavirin for 24 weeks

Or

Daklinza (Daclastavir+ Sofosbuvir) Bristol- Myers Squibb (BMS) without Ribavirin for 12 weeks

For Genotype 4:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Harvoni for 12 weeks

Or

Viekira Pak (without Dasabuvir) + Ribavirin for 12 weeks

Or

Sovaldi + Ribavirin for 24 weeks

or

Zepatier with or without Ribavirin for 12 weeks

For Genotype 5:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Harvoni for 12 weeks

or

Sovaldi + Ribavirin + Peg Interferon for 12 weeks

For Genotype 6:

Epclusa for 12 weeks

or

Vosevi for 12 weeks

or

Mavyret for 12 weeks**

or

Harvoni for 12 weeks

**denotes 8 weeks of treatment may be considered in patients without cirrhosis who have pre-treatment viral load (RNA) less than 6 million/IUmL

The above treatment and duration recommendations for all genotypes are from the Amercian Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of American (IDSA).

Blood tests are generally done every 4 weeks throughout treatment to check your viral load and blood levels.

Important to Remember

It’s important to know and have confidence in your treatment. These medications have gone through extensive clinical research and trials and have proved to be effective. Be patient with this process. Your journey to health is worth it.

Before Treatment Begins

Preparation time typically takes 4 weeks prior to beginning treatment. Your doctor will order baseline tests to be done prior to beginning treatment.

UT Southwestern Clinical Center for Liver Disease states it typically takes four weeks to get insurance approval and receive the medications. Even if you have given interferon injections and taken ribavirin in the past, you must attend the nurse teaching session based on the dosing schedule, and receive information on drug interactions and side effects. Patients can receive their first dose at the end of the mandatory nurse teaching session.

If possible, it is good to take a family member or friend with you to the teaching session, write down your questions and the answers. They can help support you and also learn what to expect with the treatment. You have a big support team with your doctors, nurses, medical staff, family and friends. Additional resources are also available for you to get the help you need.

Epclusa, made by Gilead Sciences

Harvoni, made by Gilead Sciences

Sovaldi made by Gilead Sciences

Viekira Pak made by AbbVie

Daklinza by Bristol-Myers Squibb (BMS)

Merck, makers of Zepatier

UT Southwestern Clinical Center for Liver Disease

Mayo Clinic

Center for Disease Control & Prevention

American Liver Foundation

See Resource & Support Listings for additional references and help.

A decades-long search for better treatments for a debilitating liver disorder is finally coming to fruition. Later this year the U.S. Food and Drug Administration is expected to approve a new pill that can cure hepatitis C—a chronic infection that afflicts about 170 million people worldwide and annually kills 350,000 people, including 15,000 in the U.S.—faster and with fewer side effects than current remedies.

The breakthrough treatment comes, however, at a price that may place it out of reach for all but the wealthiest or best-insured patients. It will contain two drugs, one of which is already available at $1,000 per dose, or $84,000 for a complete 12-week course. The dual-drug combination will likely cost even more, which has prompted outrage from physicians and patient advocates alike, as well as plans from insurers to ration the combination when it becomes commercially available.

Over the coming months, physicians, patients, economists and insurance companies will no doubt hotly debate whether the treatment is worth the full asking price. There is little doubt, however, that the medication’s effectiveness is unprecedented and that its development is a significant achievement. A closer look at the complex chemical problems that needed to be solved to develop the cure shows why.

Fast and Invisible
Cures sometimes result from happy accidents—think penicillin mold growing in an overlooked petri dish. More often they require years of research into what is causing the problem in the first place. Understanding the science behind the new hepatitis C treatment starts with deciphering the meaning of the virus’s name.

“Hepatitis” is a general term that refers to severe swelling or inflammation of the liver in response to certain drugs, toxins, excessive alcohol or infections—whether from bacteria or viruses. The letter C refers to the third in a series of viruses that researchers have isolated that specifically target and damage the liver. By the mid-1970s investigators had developed blood tests to identify hepatitis A, which typically spreads when infected individuals improperly handle food or water, and hepatitis B, which is often transmitted during sexual intercourse, the sharing of needles or contact with contaminated blood.

Soon after, researchers realized that a third form of viral hepatitis was silently spreading around the globe and that it was more likely than hepatitis A or B to result in permanent liver damage. By 1989 they had identified the virus that caused the condition. They also determined that the virus’s genes mutate very fast—a process that has generated several equally successful varieties, called genotypes, and rendered an effective vaccine impossible to create so far. Hepatitis B virus, in contrast, does not evolve as quickly, and a vaccine against it has been available since the 1980s. Infection with hepatitis A virus, which usually causes symptoms within days, can also be prevented with a vaccine.

Standard treatment for hepatitis C has long been a synthetic, injectable version of interferon, one of the immune system’s most powerful proteins, plus the antiviral drug ribavirin. The combination helps 25 to 75 percent of patients, depending on the genotype of the virus. But the side effects, including severe flulike symptoms, fatigue, depression and anemia, are often intolerable. In addition, the virus often becomes resistant to medication, allowing the disease to worsen.

Toward a Cure
Developing effective treatments against the virus required researchers to understand the structure of the various proteins that formed its outer shell, as well as the precise sequence of its genetic material, which is made up of RNA—a process that took the better part of the 1990s and involved researchers working around the globe in government, academia and industry.

With this information in hand, scientists still faced a long and costly phase of trial and error. They chose what looked like a promising target for treatment: an enzyme known as a protease that the virus depends on to make copies of itself. After several false starts, researchers at Vertex Pharmaceuticals, in collaboration with others, developed a protease inhibitor known as telaprevir, while scientists at Schering-Plough (which merged with Merck in 2009), created one called boceprevir. In clinical trials, 60 to 75 percent of patients receiving the standard treatment—ribavirin and interferon—as well as the two new drugs had no detectable signs of the virus in their bloodstream, compared with 44 percent or fewer patients receiving the typical treatment alone.

The FDA approved the new drugs in 2011, but the sense of triumph felt by many in the medical community soon gave way to disappointment. The medications had harsh side effects and worked only for those patients with a particular genetic variant of the virus known as genotype 1, which is the most common type in the U.S. and Canada but rare in many other countries with hepatitis C epidemics. Moreover, the continued need for interferon and ribavirin, with their attendant side effects, was a huge drawback.

As enthusiasm for telaprevir and boceprevir waned, other viral proteins emerged as promising drug targets. What scientists had learned from their earlier research, however, was that inactivating an enzyme or protein was not enough. To stop hepatitis C, any effective drug also had to incorporate itself into the virus’s genetic code, where it would need to halt the virus’s ability to make new copies of its genes and thus to make new virus. In addition, to avoid potentially debilitating side effects, the medication had to get to the liver quickly and directly, bypassing as many other organs as possible.

A company called Pharmasset had been looking at a group of drugs known as nucleotide analogues, which met some of these criteria, since the mid-2000s. Constructed by stitching molecules that resemble the building blocks of DNA and RNA with a molecule made of phosphorus plus oxygen (known as a phosphate), these compounds inserted themselves into the virus’s genes, where they promptly fell apart, interfering with viral replication.

Researchers then ran into a few big biochemical problems. Because the nucleotide analogues were water-soluble, they could not traverse the fatty lining of the intestine (fats and water do not mix) to reach the bloodstream and then the liver. In addition, the phosphate group carried a double negative electrical charge, further restricting its ability to move across the intestine’s electrically neutral membrane. Finally, other enzymes in the liver easily dislodged the phosphate group from the nucleotide analogue, rendering the compound ineffective.

Michael Sofia, then at Pharmasset, solved the problems by adding two compounds known as esters to the analogue. This addition both shielded the negative charges and made the drug greasy, enabling it to leave the gut. Once inside liver cells, the enzymes that had initially interfered with the phosphate group hit the ester molecules instead, leaving the active drug free to do its job. The new formulation was named sofosbuvir in Sofia’s honor; the company was purchased, in 2011, by Gilead for $11 billion.

In a large study, 295 out of 327 patients treated with sofosbuvir, as well as ribavirin and interferon, showed no signs of the virus in their blood after 12 weeks. In a more advanced trial, 12 weeks of sofosbuvir plus ribavirin yielded the same results as 24 weeks of interferon plus ribavirin: 67 percent of patients had no evidence of the virus in their blood (although side effects such as fever and depression were fewer among patients who did not receive interferon). The FDA approved sofosbuvir in late 2013 as a treatment for hepatitis C in combination with ribavirin.

Still, investigators pushed to make further improvements. During sofosbuvir’s development, they had studied other drugs that inhibited different viral proteins and that might eliminate the need for continued use of interferon and ribavirin. So they ran another study of sofosbuvir plus one such complementary drug, daclatasvir, made by Bristol-Myers Squibb. The result: nearly all patients were cured of the disease, with far fewer side effects than before. Since then, Gilead has run three additional studies of sofosbuvir paired with a different drug, ledipasvir. The combination cured at least 94 percent of patients with genotype 1 disease.

It is this combination, mixed in a single daily pill, that industry watchers expect the FDA to approve by October 2014. It heralds a new era of curative treatment for patients with hepatitis C. Similar drugs that work equally well for all genotypes are now in the final stages of clinical development.

Financial Resistance
Because the soon to be released combination pill cures hepatitis in just 12 weeks—eliminating the need for and the expense of treating an otherwise chronic illness—it may end up costing less overall than previous treatments. (Gilead is not expected to announce the retail price of the pill until it receives FDA approval.) Of course, that does not mean that patients will be to afford it.

David Thomas, director of the division of infectious diseases at Johns Hopkins University, considers the price an impediment to health care around the globe, despite the potential savings. Many people in the U.S. with hepatitis C are poor, and several hundred thousand are incarcerated. “Medication that costs more than $100,000 won’t make a big impact in prisons in Russia or for drug users in Pakistan,” Thomas says. Within the U.S., copayments may put the treatment out of reach.

The price tag has also struck a nerve among insurers and other third-party payers. “We’ve never had such a high-cost drug for such a large population,” says Brian Henry, a spokesperson at Express Scripts, which manages benefits for more than 3,500 companies. “Treatment for one hepatitis C patient now can take up a huge portion of a small business’s budget for drug spending.”

The manufacturer insists that cost will not prevent access. As it has for its HIV drugs, Gilead plans to provide patient assistance within the U.S., to license the drug (for a fee) to select generic manufacturers outside the U.S., and to lower prices in low- and middle-income countries. In Egypt, which has the world’s highest rate of hepatitis C, sofosbuvir costs $300 for a 28-day supply.

At the FDA meeting to review sofosbuvir for approval, Sofia listened to testimony from a patient who had been cured by the new drugs at practically the last minute. “Stories like this,” Sofia says, “put everything one does in perspective.” How many other patients get to tell such stories remains to be seen.

Harvoni (ledipasvir + sofosbuvir)

Summary

Harvoni is a direct-acting antiviral medication used to treat hepatitis C. It is a combination of two medications, sofosbuvir and ledipasvir. These two medications are co-formulated into one tablet. Harvoni is approved in Canada for the treatment of chronic hepatitis C in people over the age of 18 years with genotype 1 through 6 of the hepatitis C virus. Recommended use depends on the genotype. Harvoni is also approved in Canada for the treatment of chronic hepatitis C in children 12 years or older with genotype 1 of the hepatitis C virus. It is taken once a day with or without food for eight, 12 or 24 weeks. Harvoni has few side effects. Side effects are generally mild and temporary; they include tiredness and headache. Direct-acting antivirals are highly effective and cure over 95% of people with hepatitis C.

What is Harvoni?

Harvoni is a direct-acting antiviral medication that is used to treat hepatitis C. It is a combination of two direct-acting antivirals: sofosbuvir, which is an NS5B (hepatitis C virus non-structural protein 5B) nucleotide polymerase inhibitor, and ledipasvir, which is an NS5A (hepatitis C virus non-structural protein 5A) inhibitor.

Harvoni is approved in Canada for the treatment of chronic hepatitis C in people over the age of 18 years with genotype 1 through 6 of the hepatitis C virus. Recommended use depends on the genotype. Harvoni is also approved in Canada for the treatment of chronic hepatitis C in children 12 years or older with genotype 1 of the hepatitis C virus.

How does Harvoni work?

Harvoni directly blocks the ability of the hepatitis C virus to make copies of itself in the liver. Sofosbuvir interferes with the reproduction of the genetic material of the hepatitis C virus and ledipasvir works by interfering with a protein needed by the virus. Together, they greatly reduce and then stop the production of new copies of the hepatitis C virus. Over time, these actions eliminate the hepatitis C virus from the body.

Does Harvoni cure people of hepatitis C?

Direct-acting antivirals are highly effective and cure more than 95% of people with hepatitis C. Harvoni is one of these highly effective direct-acting antiviral medications.

A cure for hepatitis C is also known as a sustained virological response (SVR). A person is cured if the hepatitis C virus is no longer detected in the blood 12 weeks after the end of treatment.

If a person is cured of hepatitis C, they can be re-infected if they are exposed to the hepatitis C virus again.

How do people with hepatitis C use Harvoni?

Harvoni is taken as one tablet, once a day, for eight, 12 or 24 weeks. The length of treatment depends on a number of factors including the genotype of the virus, past treatment experience and the absence or presence of severe liver injury. Treatment generally lasts 12 weeks. People who have never been treated before, who do not have cirrhosis and who have a hepatitis C viral load below 6 million IU/ml may be eligible for eight weeks of treatment.

Each tablet is available as a fixed-combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir. Harvoni can be taken with or without food.

People with certain viral genotypes or with severe liver injury may need to take Harvoni with ribavirin. Ribavirin is another type of antiviral medication; it is not a direct-acting antiviral. Information about ribavirin is included in a separate fact sheet.

How important is it to stick to treatment?

All medications work best when they are taken exactly as prescribed and directed. People taking Harvoni should take their pills every day, as prescribed by their healthcare provider. It is very important to finish the entire course of treatment. This gives the treatment the best chance of working to cure hepatitis C.

What can be done about missed doses?

When a person taking Harvoni misses a dose and it is within 18 hours of when it should have been taken, it is important to take the missed dose immediately or as soon as possible. If it has been more than 18 hours since a dose was supposed to have been taken, that dose should be skipped and the next dose should be taken at the appropriate time. A double dose should not be taken. A person should continue their treatment until all doses have been taken.

If a person finds it difficult to stick to treatment, it is important to discuss this with their nurse or doctor. Tips for sticking to treatment can be found in CATIE’s Hepatitis C: An In-depth Guide.

Warnings

1. Risk of hepatitis B virus reactivation in patients co-infected with hepatitis C and hepatitis B viruses

The U.S. Food and Drug Administration (FDA) recommends that all people starting hepatitis C treatment with direct-acting antiviral medications should be tested for hepatitis B before starting treatment.

There have been a small number of reports of reactivation of hepatitis B virus infection when direct-acting antivirals like Harvoni are used to treat hepatitis C infection in people who are co-infected with hepatitis B virus. Reactivation of hepatitis B virus can, in some cases, cause serious complications. People considering the use of Harvoni should speak with their doctor or nurse about their hepatitis B virus infection status.

2. Cardiovascular effects

The manufacturer of Harvoni, Gilead Sciences, states that there have been cases of problems in some people who have taken the heart drug amiodarone and medicines containing sofosbuvir. Harvoni contains sofosbuvir. Therefore, Gilead recommends that Harvoni not be used by people who take amiodarone.

3. Breastfeeding/Chestfeeding

People with infants and who are taking Harvoni should not breastfeed or chestfeed their children. It is not known whether the medication is present in human milk.

4. People aged 12–18 years without genotype 1 virus and all children under the age of 12 years

The effectiveness of treatment with Harvoni for people aged 12 to 18 years who are infected with a genotype of the hepatitis C virus other than genotype 1 has not been determined. The safety and effectiveness of treatment with Harvoni for children under the age of 12 years has also not been determined.

5. Special populations

People with any of the following conditions should speak with their doctor or nurse about the most appropriate hepatitis C treatment options for them:

  • pregnancy or planning a pregnancy while on treatment for hepatitis C
  • liver issues other than hepatitis C
  • liver transplant
  • severe kidney injury or on dialysis
  • co-infection with hepatitis B
  • co-infection with HIV
  • rare hereditary condition of galactose (milk sugar) intolerance

Harvoni is generally safe and highly effective. Anyone who is considering treatment with Harvoni should discuss all of their medical conditions with their doctor or nurse.

Side effects

The most common side effects of Harvoni are:

  • fatigue (extreme tiredness)
  • headache

In most cases these side effects are mild or moderate and gradually resolve.

Drug interactions

Some prescription drugs, over-the-counter drugs, herbs, supplements and street drugs can interfere with the absorption and/or the effectiveness of Harvoni. This is called a drug interaction.

Some drugs taken for other conditions can interact with Harvoni, increasing or decreasing the level of one or both drugs in the body. Increased levels can lead to new or more severe side effects. Decreased levels may mean that the drug won’t be as effective.

It is important that people discuss all medications, supplements, herbs and street drugs they are taking with their doctor, nurse or pharmacist. If a person has more than one doctor or pharmacist, it is possible for drug interactions to get missed. Using the same pharmacy for all prescriptions can be helpful.

This fact sheet is not comprehensive and lists only some of the potential and actual drug interactions with Harvoni. Speak with a pharmacist to find out more about drug interactions with Harvoni.

The manufacturer of Harvoni does not recommended taking Harvoni with the following medications and medicinal supplements:

  • medication to treat irregular heartbeat, such as amiodarone
  • anti-seizure medications, such as carbamazepine (Tegretol), phenobarbital and phenytoin (Dilantin)
  • tuberculosis medication, such as rifampin
  • the HIV medication tipranavir (Aptivus) + ritonavir (Norvir)
  • the hepatitis C medication simeprevir (Galexos)
  • the cholesterol-lowering medication rosuvastatin (Crestor)
  • any medicinal herbs, especially St. John’s wort (Hypericum perforatum), which is an herb used to treat depression, or hyperforin or hypericin, which are active ingredients in St. John’s wort

When Harvoni is taken with the following medications it could potentially cause significant drug interactions:

Availability

Harvoni, manufactured by Gilead Sciences, has been approved by Health Canada and is available in Canada. Pharmacists are a good source of information about public and private health insurance coverage for Harvoni.

The “Treatment coverage in your region” section of CATIE’s Hepatitis C: An In-depth Guide contains information about provincial and territorial drug coverage.

Acknowledgement

We thank Curtis Cooper, MD, FRCPC, for expert review.

Gilead Sciences. Harvoni (Ledipasvir/Sofosbuvir). Product monograph. June 27, 2019.

Pros and Cons of New Hepatitis C Drugs

Hepatitis C treatment is getting faster, simpler, and more effective.

Patients on the new hepatitis C medication, Harvoni, need only pop one pill per day. Some can be cured in as little as eight weeks. And patients who take Viekira Pak, a new combination pill, for 12 to 24 weeks, don’t need an added injection. This is a huge difference from just a few years ago, when hepatitis C patients had to take ribavirin pills and interferon injections for almost a year, and most weren’t cured.

“Harvoni is very easy to take, it doesn’t have any significant side effects,” says David Bernstein, MD, chief of hepatology for the North Shore LIJ Health System in Manhasset, N.Y. “The only thing that you see is some patients get an occasional mild headache, which is easily treatable with aspirin or Tylenol.”

Prior interferon-containing combo treatments had side effects that included anemia, depression, and flu-like symptoms among others.

Here’s the problem: The newer hepatitis C drugs are super-expensive. Harvoni rings in at $1,125 per pill, or $94,500 for a 12-week course of treatment, and other new medications are nearly as pricey. Insurers are scrambling to figure out how to pay for treatment without breaking the bank. Many say they will only cover costly therapies for the sickest patients. In comparison, the cost 11 out of 12 cancer drugs the FDA approved in 2012 for cancer chemotherapy was over $100,000 for a one-year treatment course.

“Really curing hepatitis C is now within reach for a majority of the patients that we see,” says Andrew Aronsohn, MD, an assistant professor of medicine at The University of Chicago Medicine and an expert on hepatitis treatment. “The big issue revolves around cost and access to care.”

Several other new hepatitis C treatments are awaiting FDA approval. “The hope is that with lots of competition and more drugs out there, the price will go down,” says Dr. Aronsohn. “That’s certainly what we’re hoping for.” A potential problem with using the new drugs is how to know which will be best for an individual patient, when compared to other new treatments.

Hepatitis C Treatments

Here’s a rundown of US Food and Drug Administration-approved treatments for hepatitis C, from newest to oldest.

Viekira Pak: Approved December 2014. Viekira Pak is an interferon-free, all oral cure for hepatitis C for patients who have genotype 1 infections, including those with cirrhosis. The combination is ombitasvir, paritaprevir, and ritonavir pills, combined with dasabuvir pills. It is sometimes used with ribavirin. Patients take the drug for 12 to 24 weeks, and it cures over 95 percent.

Harvoni: Approved October 2014. Harvoni is a combination of sofosbuvir (Sovaldi) and ledipasvir. The drug cured more than 90 percent of patients with hepatitis C type 1, the most common form in the United States, after 12 weeks of treatment. Some patients who have not taken antiviral drugs before can be cured in eight weeks. “It’s quite a transformative medication,” Dr. Bernstein says.

Sovaldi: Approved December 2013. Sovaldi is also a once-a-day pill, taken in combination with ribavirin or interferon. A course of treatment lasts 12 weeks, versus 24 to 48 weeks for older treatments. Some doctors have been prescribing an off-label combination (meaning not specifically FDA-approved) of Sovaldi with Olysio (simeprevir) to avoid side effects associated with the older drugs. The two-drug combo costs roughly $150,000 for a course of treatment. Patients with hepatitis C genotype 2 and genotype 3 are currently treated with a combo of Sovaldi and ribavirin, while patients with genotype 4 — who are very rare in the United States — must still be treated with interferon and ribavirin.

Olysio (simeprevir): Approved November 2013. Olysio is a once-a-day pill and, like Sovaldi, approved for use in combination with interferon and ribavirin. It is approved for treating hepatitis C genotype 1. The drug combination cured 80 percent of those with hepatitis C in 24 weeks, including patients who failed earlier drug treatments.

Telaprevir (Incivek/)/Boceprevir (Victrelis): Approved May 2011. Telaprevir and boceprevir were the first new treatments available for hepatitis C in 20 years. These drugs were also the first to directly attack the hepatitis C virus. Both are protease inhibitors, and prevent the virus from making copies of itself. Either must be taken along with ribavirin and interferon, but the course of treatment for the triple combo takes 24 weeks, versus 48 weeks for the interferon/ribavirin only regimen. Cure rates are about 80 percent with the telaprevir-based combo, while the boceprevir-based combo cures about two-thirds of patients.

Ribavirin: Approved in 1998. Patients take this oral medication twice a daily, and it must be used in combination with interferon. Side effects include a serious form of anemia that can make heart disease worse and lead to a heart attack. A course of interferon/ribavirin therapy lasts 48 weeks, and will cure about 40 percent to 45 percent of patients.

Interferon: Approved in 1991. Interferon is a human-made copy of an infection-fighting substance produced by immune-system cells. Patients must take it by once-weekly injection. Side effects can be severe, and include depression, irritability, flu-like symptoms, and blood abnormalities. When the drug was used on its own to treat hepatitis C, patients had to take it for 12 to 18 months. This lengthy treatment cleared the virus in just 20 percent of patients.

RELATED: How to Pay for Costly Hepatitis C Drugs

Hepatitis C Treatment Side Effects

Like most drugs, hepatitis C medications may cause side effects. Before 2014, the drugs used to treat chronic hepatitis C virus (HCV) infection had many side effects, some of which were severe. The newest HCV drugs have fewer and milder side effects. Also, treatment lengths are shorter; less exposure to the medicines reduces the risk of side effects. The majority of people who used the new medicines in clinical trials experienced mild side effects. However, even though the risks are low, it is wise to know about potential side effects before starting a drug, along with tips that may help reduce the risk.
Although it is rare, side effects can develop into potentially life-threatening problems, especially if they are ignored or dismissed. The best way to handle side effects is to intervene early, reducing or stopping problems before they get out of control. Tell your health care provider about any side effects you may be having. You or your provider can report suspected adverse reactions to the U.S. Food and Drug Administration (FDA) at 800.332.1088 or to the drug manufacturer.
Here is a list of common side effects for approved HCV medications, along with tips for managing them if they occur. Because most HCV drugs are combined with other medications, review the side effects for all the medicines you are taking.
Approved hepatitis C drugs:

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir + velpatasvir)
  • Harvoni (ledipasvir + sofosbuvir)
  • Mavyret (glecaprevir + pibrentasvir)
  • Pegasys (peginterferon)
  • Ribavirin (Brand names include Copegus, Moderiba, Ribasphere)
  • Sovaldi (sofosbuvir)
  • Vosevi (sofosbuvir+velpatasvir+voxilaprevir)
  • Zepatier (elbasvir + grazoprevir)

Daklinza (daclatasvir)
Approved to treat genotypes 1 and 3 HCV, Daklinza is prescribed with Sovaldi (sofosbuvir), with and without ribavirin.

  • Diarrhea
  • Fatigue
  • Headache
  • Nausea

Epclusa (sofosbuvir + velpatasvir)
Approved to treat genotypes 1 through 6 HCV, Epclusa may be prescribed with ribavirin in those with decompensated cirrhosis.

  • Fatigue
  • Headache

Harvoni (ledipasvir + sofosbuvir)
Approved to treat genotypes 1 and 4 HCV, may be prescribed with ribavirin.

  • Diarrhea
  • Fatigue
  • Headache
  • Insomnia
  • Nausea

Mavyret (glecaprevir + pibrentasvir)
Approved to treat genotypes 1 through 6 HCV.

  • Fatigue
  • Headache
  • Nausea

Pegasys (peginterferon)

Newer drugs known as direct-acting antivirals (DAAs) are replacing peginterferon (PEG). PEG may be used as an alternative treatment when other treatments fail to work.

PEG is usually prescribed with two other HCV medications, ribavirin and a DAA. With over 40 potential side effects, PEG is the HCV medication with the highest risk.
These are the most common side effects:

  • Cough, runny nose, sore throat
  • Depression, irritability, moodiness, anxiety
  • Dizziness
  • Dry mouth, skin, eyes
  • Fatigue, weakness
  • Flu-like symptoms (chills, fever, joint and muscle aches)
  • Gastrointestinal disorders (abdominal pain, decreased appetite, diarrhea, nausea)
  • Hair loss
  • Headache
  • Injection site reaction
  • Insomnia
  • Neutropenia (low white cells)
  • Pain (back, joint, muscle)
  • Thrombocytopenia (low platelets)

Ribavirin (Brand names include Copegus, Moderiba, Ribasphere)
Ribavirin is prescribed with one or more other HCV medications. In many cases, newer drugs are replacing the need for ribavirin.
Warning: Ribavirin causes birth defects in animals, so it cannot be used by women who are pregnant or by the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy while taking the drug. As a result, men and women who are having intercourse must use two forms of birth control during HCV treatment and for the next six months afterward, since ribavirin can remain in the bloodstream after people stop taking it.

  • Anemia, hemolytic (low red cells)
  • Dizziness/lightheadedness*
  • Fatigue*
  • Impaired concentration*
  • Increased heart rate*
  • Insomnia
  • Loss of appetite
  • Mood issues (anxiety, depression, irritability, moodiness)
  • Nausea
  • Rash/itching/dry skin
  • Shortness of breath*
  • Taste perversion (dysgeusia)
  • Upset stomach (dyspepsia)
  • Weakness*

*Symptom of anemia
Sovaldi (sofosbuvir)
Sovaldi is prescribed with one or more other HCV medications.

  • Fatigue
  • Headache
  • Nausea

Vosevi (sofosbuvir + velpatasvir + voxilaprevir)
Approved to treat genotypes 1 through 6 HCV.

  • Diarrhea
  • Fatigue
  • Headache
  • Nausea

Zepatier (elbasvir + grazoprevir)
Approved to treat genotype 1 and 4 HCV. Zepatier may be prescribed with or without ribavirin.

  • Anemia (when used with ribavirin)
  • Diarrhea
  • Fatigue
  • Headache (when used with ribavirin)
  • Insomnia
  • Nausea

Last Reviewed: January 4, 2019

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What Are the Side Effects of Hepatitis C Treatment?

The main types of HCV medications prescribed today are direct-acting antivirals (DAAs) and ribavirin. In rare cases where DAAs are not accessible, interferons may be prescribed.

DAAs

Today, DAAs are the standard of care for those with chronic hepatitis C. Unlike previous treatments, which could only help people manage their condition, DAAs can cure HCV infection at a much higher rate.

These drugs may be available as individual drugs or as part of a combination therapy. All of these medications are taken orally.

Individual DAAs

  • dasabuvir
  • daclatasvir (Daklinza)
  • simeprevir (Olysio)
  • sofosbuvir (Sovaldi)

Combination DAAs

Ribavirin

Ribavirin is a medication used in combination with other drugs to treat HCV. It used to be prescribed primarily with interferons. Today it’s used with certain DAAs against resistant HCV infection. Ribavirin is often used with Zepatier, Viekira Pak, Harvoni, and Technivie.

Interferons

Interferons are medications that used to be the primary treatment for HCV. In recent years, DAAs have taken over that role. That’s largely because DAAs cause far fewer side effects than interferons do. DAAs are also able to cure HCV with higher frequency.

Title: Healthy habitsWhile side effects are an understandable concern during treatment for hepatitis C, you should also focus on being in good health. You should eat a well-balanced, nutritious diet and make sure to drink plenty of water to avoid dehydration. It’s also important to avoid smoking and alcohol since these habits can have a very negative effect on the health of people with hepatitis C.

Hepatitis C Treatment: ‘Why miss out’

The theme for 2018’s National Hepatitis Awareness Day was ‘Why miss out’. This refers to the new treatment for Hepatitis C that, from 2016, became available to all Australians living with a positive diagnosis of HCV at an affordable price ($6.40 if a holder of a government concession card or $39.50 full script price per month). The new generation of direct action anti-viral medication is showing a cure rate of 90 – 95%, has very few side effects, and for most people duration of treatment is as little as 8 – 24 weeks. Previous generations of medication had a much lower success rate and the side effects and suitability meant many people were ineligible for treatment.

In 2016 an estimated 227,306 people were living with chronic Hepatitis C. Of this number, it is estimated that 80% have been diagnosed and 47% of those diagnosed have had complete diagnosis using the World Health Organisations criteria.1 In 2016, diagnosis of HCV increased by 12% which may reflect more people being tested due to the availability of the new treatment.2

Hepatitis

Hepatitis is a liver infection caused by a virus. There are three main types:

  • Hepatitis A (HAV) – a short lived liver infection caused by contaminated food or water. This virus is short lived (1 – 3 weeks) and in most cases has no long-term effects. There is an effective vaccine against HAV.
  • Hepatitis B (HBV) – transmitted via blood or other body fluids including in some cases mother to baby. Most adults who are exposed to the virus clear the infection after 4 – 6 weeks however children exposed to the virus often have HBV for life and have an increased risk of liver disease later in life. There is currently no cure for HBV but treatment to prevent liver damage is available. Hepatitis B can be vaccinated against and HBV vaccine is now on the childhood vaccination schedule.
  • Hepatitis C (HCV) – transmitted via blood to blood. Symptoms rarely displayed until many years after infection when person may present with liver damage. Previously, a diagnosis of HCV resulted in life long infection and an elevated risk of liver disease and cancer. HCV is now curable.3

A bit more about Hepatitis C

Hepatitis C is transmitted via blood to blood contact. Prior to 1990 people who received a blood transfusion may have been at risk of contracting Hepatitis C if the blood contained Hepatitis C. All donated blood is now screened for the presence of the virus. People who have or do inject drugs carry a significant burden of and risk of new infection. Access to clean injecting equipment via needle and syringe programs has reduced the rate of new infections however the burden of disease for those already infected remains high. There are no restrictions on access to treatment applied to people who still inject drugs.

Barriers to successful treatment

In Australia the current testing to treatment pathway has a high dropout rate. This is partially due to the time and number of appointments necessary prior to beginning treatment, the cost and the accessibility to a high risk marginalised community. Other barriers to successful treatment include diagnosis burden and lack of cultural safety. A positive diagnosis of HCV also carries with it a significant stigma. People with a diagnosis often report a history of negative interactions with health care practitioners if they disclose their positive HCV status which, in turn, further decreases treatment potential.

New rapid test kits have been used internationally which reduce the number of steps between testing and treatment. The introduction of this new test in Australia will make testing more available in venues where people who inject drugs are more likely to engage (needle and syringe programs/opioid substitution prescribing clinics) and may help to engage a difficult to reach population group. Further to this, training of nurse practitioners to prescribe may help potentially increase uptake of treatment and help minimise drop-out rates. 4

New Hepatitis C treatment

Treatment for Hepatitis C has undergone a revolution in recent years. With the introduction of a new generation of direct action anti-viral medication that are easy to take and with few side effects than previous available treatments.

The World Health Organisation (WHO) has set targets to have 90% of all chronic hepatitis C infections globally diagnosed and 80% of those eligible for treatment to be virus free by 2030.1 Australia is currently the only country that is on track to achieve this if access to diagnosis and treatment continues to follow the current trends.1

Hepatitis C Cure Rate: Know the Facts

For many years, one of the only effective treatment options was the drug interferon. This drug required many injections over a period of six months to a year. The drug also produced unpleasant symptoms. Many people who took this drug felt like they had the flu after their treatment. Interferon treatments were only effective about half the time, and they couldn’t be given to people with advanced HCV because it could worsen their health.

An oral drug called ribavirin was also available at this time. This drug had to be taken with interferon injections.

More modern treatments include oral medications that shorten the time needed to be effective. One of the first to emerge was sofosbuvir (Sovaldi). Unlike other early treatments, this drug didn’t require interferon injections to be effective.

In 2014, the U.S. Food and Drug Administration (FDA) approved a combination drug made up of ledipasvir and sofosbuvir (Harvoni). It’s a once-daily medication in a class of drugs called direct-acting antivirals. These drugs work on the enzymes that help the virus multiply.

Treatments approved after Harvoni were designed to target people with different genotypes. A genotype can refer to a set of genes or even one gene.

Researchers have found that different drugs are more effective based on a patient’s genotype.

Among the drugs approved from 2014 on are simeprevir (Olysio), to be used in combination with sofosbuvir, and daclatasvir (Daklinza). Another combination drug, composed of ombitasvir, paritaprevir, and ritonavir (Technivie) was also very effective in clinical trials. One percent of people taking Technivie experienced elevated liver enzyme levels. This abnormal liver function was seen primarily in women taking birth control pills. Other drugs are available based on genotype and prior treatment history.

Interferon injections had a cure rate of about 40 to 50 percent. Newer pill treatments have cure rates of nearly 100 percent. In clinical trials, Harvoni, for example, achieved a cure rate of about 94 percent after 12 weeks. Other drugs and combination medications had similarly high cure rates in that same time frame.

Harvoni during pregnancy, nursing, and in children:

It is not known whether Harvoni causes harm to unborn babies. If you are pregnant or planning pregnancy, talk with your health care provider about the risks and benefits of HCV treatment. It is not known whether Harvoni passes into breast milk. Harvoni is under study in children (ages 3 to 18).

Ribavirin causes birth defects, and it can be fatal to unborn babies. Ribavirin should not be used by pregnant women, or by male partners of pregnant women. Ribavirin stays in a person’s body for months. Women and their male partners should avoid pregnancy for six months after they have stopped taking ribavirin. Using two forms of birth control to prevent pregnancy while taking ribavirin—and for six months afterwards—is recommended. Nursing during treatment with ribavirin is not recommended. (See the Ribavirin Fact Sheet for more information)

There is a ribavirin pregnancy registry at: http://www.ribavirinpregnancyregistry.com.

Access to Harvoni

Access may be restricted by public and private payers. The criteria differ depending on the type of coverage and the state it is issued in. Support Path is Gilead’s patient assistance program for Harvoni. People with private insurance may be eligible for assistance with copayments. Uninsured people may be eligible for medication at no charge. Information about Support Path is available online at: http://www.gilead.com/responsibility/us-patientaccess/ support%20path%20for%20sovaldi%20and%20harvoni. Information about Support Path is also available by phone at 1.855.769.7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time), or online at: https://www.harvoni.com/support.

This fact sheet is current as of April 2016. Always check for updated information.

“They ask for more tests and they ask for specific tests,” Bordon said.

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At tens of thousands of dollars per patient, insurance providers want to make as sure as possible that each patient will be cured quickly.

“We asked for Zepatier next,” Tia said. Another no. Finally, Bordon and Tia’s provider settled on Epclusa, one of the newer of the new hepatitis C drugs.

Tia started taking Epclusa last year. She followed directions carefully.

“I had to stop drinking wine,” she said. “I had to go cold turkey — no wine for three months. That’s a long time.”

But even so, after a few weeks, it became clear it wasn’t working.

Tia wasn’t despondent, but she was disappointed and a little fearful.

More tests followed. Was it resistance? Had the virus in her body somehow evolved to defy the drug’s effects? Was it a supplement she took?

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Often, patients don’t take hepatitis drugs as they should. Drug users may sell the valuable pills, or patients may forget a few doses, allowing the virus to mutate. Tia did not fall into either category.

Bordon now thinks it was likely one of the many “natural” supplements that Tia had been taking interfered with the drug’s action, making it less effective and allowing virus to survive in her body.

“Supplements can screw up hepatitis C treatments,” said Dr. Douglas Dieterich, director of the Institute of Liver Medicine at the Icahn School of Medicine at Mount Sinai in New York.

“They can cause drug toxicity. They can interfere with liver enzymes which can reduce the levels of the drugs. The most common one is St. John’s wort.” St. John’s wort is a plant that many people use to treat depression symptoms, but it’s metabolized in the liver in a way that can interfere with many pharmaceutical drugs.

Tia had no idea that herbal or “natural” supplements could do this.

“It was part of her normal life to take all these supplements,” Bordon said.

Barriers to treatment

Now, Tia would have to try a different hepatitis C drug. There are several on the market, but that was where she ran into policy wars. Many insurers are reluctant to pay for a second round of treatment.

“They don’t want to pay for it unless you fight,” Tia said.

Salo said there are some reasons for this reluctance, not the least the cost. If every Medicaid patient in a state showed up at once asking for treatment, “it would bust the budget,” he said.

Medicaid is a state-federal health insurance plan for people with low incomes and no other source of health insurance. Some states, such as New York and California, put a lot into their plans while others have smaller budgets.

“A lot of states put restrictions in place and said let’s try to prioritize the sickest first,” Salo said. “States were trying to buy themselves time to give time for the price to come down.”

The prices of the hepatitis C drugs are coming down as more companies develop their own versions and competition kicks in. AbbVie’s Mavyret is priced at $26,400 for a treatment round, a price that has pressured other companies to lower their prices.

“Now that there are multiple drugs on the market, prices have obviously been driven down,” Dieterich said. “The insurance companies have contracted with pharma and they have their preferred products,” he added.

But still, he said, insurance companies and state Medicaid programs often put up barriers if they can.

“There are always plans that are trying to get out of it…by having alcohol tests or marijuana tests. Even if you are smoking marijuana, they’ll exclude them,” Dieterich said.

Last October, the AIDS Institute, which also represents patients with hepatitis, said 31 states and Washington, D.C. decline to treat patients until they have moderate or worse liver damage.

Or they balk at treating patients, like Tia, whose first course of treatment fails.

People can be cured of hepatitis C but they are not immune from getting it again. Some states fear that people who had been infected through risky behavior, such as injecting drugs, might get re-infected, and they’d end up treating the same patients over and over.

That is a shortsighted policy, argued Alyson Harty, clinical nurse manager for Mt. Sinai’s liver institute.

“Even if a patient doesn’t need a transplant, the cost of cirrhosis care for a patient that’s in and out of the hospital over even a year is way more than the cost of treatment,” she said.

And the cure rate is high. “In my office, more than 93 percent of patients treated for hepatitis are cured,” Bordon said.

‘We are going to beat this’

In Tia’s case, Bordon ran the requested tests. He filed an appeal with the insurance company providing Tia’s Medicaid coverage.

“This is crazy,” Tia said as she waited to hear if she would be covered. “I called back again and again. How can an insurance company say they’ll only cover one treatment in a patient’s lifetime?”

Because she had developed some cirrhosis, a board finally determined she was eligible to receive a second round of treatment. She was sick enough to qualify for Vosevi, a combination of three hepatitis C drugs that’s approved for cases like hers.

She started taking it in April and is feeling optimistic. “I am hoping my liver will regenerate,” she said.

Bordon said indications are that Tia’s will, and the medication is knocking down the virus, he said. She’ll be taking the pills for three months.

Two weeks in, Tia had good news. “The virus is almost undetectable,” she said.

“I feel good,” she added. “I have a plan. We are going to beat this.”

Update: As of July 20, after six weeks of treatment, a blood test could not detect any hepatitis virus in Tia’s blood.

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