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Hep C & Harvoni: 11 Facts About Your Treatment

Medically reviewed by L. Anderson, PharmD. Last updated on Apr 28, 2018.

HCV and Harvoni: Interferon-Free

New treatments for chronic hepatitis C virus (HCV) -- the blood-borne infectious disease that can lead to:

  • chronic liver disease
  • liver inflammation and scarring
  • liver cancer
  • eventual liver transplant

have been the focus of rapidly evolving research.

In the past, treatment options for HCV were burdened by lack of an all-oral regimen, unpleasant side effects with interferon, and treatment courses often exceeding one year. Today, oral treatment regimens aim to be more tolerable, interferon-free, and with shorter treatment times -- some as short as 8 to 12 weeks. But how are these drugs used?

Here's a quick rundown of Harvoni (ledipasvir and sofosbuvir), the first approved all-oral, ribavirin and interferon-free HCV treatment.

What Exactly is Harvoni?

HCV treatment has come a long way -- very quickly. In fact, in 2012 the typical treatment for hepatitis C involved a combination of an injectable antiviral interferon and ribavirin. These regimens led to a cure in only about half of patients, took at least 6 months to complete, and often failed due to intolerable side effects.

Harvoni is Gilead's NS5A inhibitor (ledipasvir) and nucleotide polymerase (NS5B) inhibitor (sofosbuvir). Harvoni prevents hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given by mouth once a day for 8, 12, or 24 weeks, depending upon your HCV status.

Harvoni is a combination drug containing 90 mg of ledipsavir and 400 mg of sofosbuvir for the treatment of adults with chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.

It's also approved for adults with:

  • HCV/HIV-1 co-infection
  • HCV genotype 1 and 4 liver transplant recipients, without cirrhosis or with compensated cirrhosis, in combination with ribavirin
  • genotype 1-infected patients with decompensated cirrhosis (with ribavirin)

Harvoni can be used in children 12 years of age and older or weighing at least 35 kg (77 pounds) with genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis.

Get to Know Your Genotype

Before you can be treated for HCV, you'll need to know your genotype. A genotype is a particular gene set carried by an individual.

There are six different genotype classifications for HCV, and at least 50 subtypes, based on the genetic material in the RNA. Generally, patients are only infected with one genotype, but genotypes can mutate quickly and become drug resistant. Superinfection -- infection with more than one genotype -- is possible (but rare).

Effectiveness of drugs vary based on which HCV strain a patient is infected with; for example:

  • Harvoni, (ledipasvir/sofosbuvir) approved in 2014, can be used for genotype 1, occurring in roughly 70% of infected patients, as well as types 4, 5 and 6.
  • Epclusa, a new "pan-genotypic" once-daily HCV drug was approved in June 2106. Epclusa (sofosbuvir/velpatasvir) (SOF/VEL) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination that treats all major HCV genotypes 1 through 6.

Prior to HCV Treatment

In addition to determination of HCV genotype, previous treatment failures (if any), presence of cirrhosis (liver disease) or kidney disease, possible drugs interactions and side effects, cost and insurance coverage need to be discussed with your doctor.

Newer HCV treatments are costly and you should investigate how they will be paid for before treatment. The Harvoni manufacturer Gilead may be able to offer copay coupons or other assistance to patients who cannot afford their medication.

Selection of HCV treatment can be a complicated decision that often requires the expertise of a clinical specialist. Be sure to discuss your treatment plan with your primary care physician to determine if specialist care is needed. Tell your doctor if you have a history of liver disease, kidney problems, HIV, or if you're pregnant, breastfeeding or planning a pregnancy.

Harvoni: A First-Line Choice

Harvoni is a recommended treatment for HCV in guidelines, and in general, it's an easy regimen. Harvoni treatment results in hepatitis C cures in roughly 95 to 99% of patients (95 to 99 out of every 100 patients).

Your treatment regimen and length will vary according to your liver condition and whether or not you have received prior treatments.

  • Most patients who have never had treatment, and without liver disease, will only have to take Harvoni for 12 weeks.
  • Some patients with low amounts of virus in their blood may only need to take Harvoni for 8 weeks.
  • Patients who have received other HCV drug treatments in the past without success may need to extend the Harvoni regimen to 24 weeks.
  • People at risk for more severe liver disease may need to combine Harvoni with ribavirin, another antiviral medication, but only for 12 weeks. If Harvoni is given with ribavirin, also be sure to follow the ribavirin prescribing information.

Harvoni Dosing and Side Effects

The dosage of Harvoni is one tablet taken orally once daily with or without food. It's best to get in a routine and take it the same time every day. Don't change your dose or stop taking your medicine unless directed to do so by your doctor.

Usually, the side effects that occur with Harvoni are mild. In fact, in clinical studies, only 1% (1 out of 100) or less of patients stopped treatment due to side effects. The most common side effects occurring in greater than 5% to 10% of patients included:

  • headache
  • fatigue
  • asthenia (lack of energy)
  • nausea
  • insomnia
  • diarrhea.

In addition, all patients should be tested for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Harvoni. As noted in a Harvoni boxed warning, HBV reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.

Co-Infection with HIV

Up to one-third of patients with HCV also have HIV in the US. Co-infection can increase the risk for advanced liver disease (cirrhosis), end-stage liver disease, and liver cancer.

In November 2015, the FDA approved Harvoni to be used in patients co-infected with HIV. The dosing regimens in HIV/HCV co-infected patients are the same as for patients without HIV, and HCV cure rates (SVR12) are in the range of 96%.

However, there are important drug interactions with Harvoni, including with various HIV treatments, such as any medicine containing tenofovir (Truvada, Viread, Atripla, Complera, Stribild).

Patients should discuss these interactions with their doctor and pharmacist and have a drug interaction review performed each time they start or even stop a medication. Patients should tell their doctor and pharmacist about all the medicines they take, including:

  • prescription
  • over-the-counter
  • vitamins
  • herbal supplements.

Serious Drug Interaction Concerns

A slowed heart rate (bradycardia) can occur in patients who take Harvoni in combination with amiodarone (Cordarone, Pacerone), a drug used to control the heart's rhythm. Bradycardia may be more serious in patients also taking beta blockers with amiodarone and Harvoni, or those with underlying heart disease and/or advanced liver disease.

  • The manufacturers do not recommended that amiodarone and Harvoni be given together. If you have no other options for treatment, your doctor will monitor your heart function closely.
  • Harvoni should not be used with other drugs that also contain sofosbuvir.
  • Medicines such as St. John's Wort and rifampin may alter drug levels of Harvoni, so these should be avoided.
  • If you take the blood thinner warfarin, frequent monitoring of your international normalized ratio (INR) values is recommended.

Do NOT stop medications on your own and remember to get a drug interaction review with each new or discontinued drug.

Show Me the Money

There's no question that Harvoni is a blockbuster drug - at $95,000 per treatment regimen. In fact, all of the new CV oral agents are very expensive, and usually out of the reach for patients without adequate insurance. If you are not able to afford your medications, be sure to contact the manufacturer and ask about any available Patient Assistance Programs.

It may be worthwhile to check with your health insurance before you and your doctor decide upon Harvoni as your treatment of choice, as many insurance companies may have other preferred regimens that you may have to try first, or use instead.

Millions of people worldwide are still untreated or undiagnosed for HCV, with a need to be cured. These drugs are important to bring a cure to HCV, but they must be financially accessible, as well.

Cost Versus Benefit

The hepatitis C franchise has been a strong money-maker for pharma, particularly with the advent of the all-oral, direct-acting antivirals that boast cure rates of up to 99%.

But the $95,000 per 12-week treatment price tag for Harvoni is a hard pill to swallow. Many consider the costs of these new drugs unsustainable for patients, payers or the healthcare system as a whole. However, most insurance companies include at least one direct-acting HCV antiviral on their formulary.

It's important to consider the costs of HCV to society -- by 2024 this figure may top $9 billion. Some experts state that these drugs are game changers, and most patients would agree. But still, there are roadblocks:

  • Oral, direct-acting antivirals for HCV will save millions in healthcare costs related to liver cancer, liver transplants and overall HCV care, and that their benefit is well worth the cost.
  • Some patients aren't able to access these drugs because insurance guidelines often prohibit their use until a later stage of HCV disease, or their deductibles or co-insurance are too high.
  • Manufacturers may be able to give financial support, so check other avenues for patient assistance.

What Are Your Thoughts?

You are the consumer, the patient, and the center of the healthcare system.

So what are your thoughts about the new HCV oral treatments? Have you used them and what are your experiences? Consider joining the Hepatitis C Virus Support Group to voice your opinion and lend facts to the discussion.

You can also ask questions, browse answers, and stay up-to-date with the latest news and FDA drug approvals, including the latest HCV antivirals.

You can conquer HCV, and empower yourself with health knowledge you need to stay well.

Finished: Hep C and Harvoni: 11 Facts About Your Treatment

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