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Hep C & Harvoni: 11 Facts About Your Treatment

Medically reviewed on Apr 06, 2017 by L. Anderson, PharmD

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, inflammation, scarring, liver cancer, and liver transplant - have been the focus of rapidly evolving research over the last few years.

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. Newer oral treatment regimens aim to be more tolerable, interferon-free, and with shorter treatment times - some as short as 8-12 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?

Harvoni is Gilead's NS5A inhibitor (ledipasvir) and nucleotide polymerase (NS5B) inhibitor (sofosbuvir). Harvoni is a fixed-dose combination containing 90 mg of ledipsavir and 400 mg of sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

It's also approved for patients with HCV/HIV-1 co-infection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.

Harvoni prevents hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given once a day for 8, 12, or 24 weeks, depending upon your HCV status. 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 (such as Pegasys, PegIntron, Sylatron or Intron A) 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.

Get to Know Your Genotype

Before you can be treated for HCV, you'll need to know your genotype. 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) if HCV risk behaviors like injection drug use continue.

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 (1-855-769-7284) 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 one of the first-line recommended treatments for HCV in guidelines, and in general, it's an easy regimen. Harvoni treatment results in hepatitis C cures in roughly 95-99 percent (95-99 out of every 100) of patients.

Your treatment regimen and length will vary according to your liver condition and whether or not you have received prior treatments. Most patients 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, 1% (1 out of 100) or less of patients stopped treatment due to side effects. The most common side effects occurring in greater than 10% of patients included headache, fatigue, and asthenia (lack of energy). Other common side effects reported by the manufacturer and observed in at least 5% of patients were nausea, insomnia and diarrhea.

A study published in Jan. 2017 from the Institute for Safe Medication Practices (ISMP) raises concerns about increased liver side effects with the newer HCV agents. An FDA safety database review shows cases of severe liver injury, liver failure, and deaths with these drugs. However, one manufacturer states that they have seen no link of elevated liver disease and drug treatment from post-marketing reports. In addition, these drugs are prescribed for high-risk patients who may develop liver disease despite treatment. The study does not prove that the treatments cause liver damage, as it was not a randomized, controlled trial.

Co-Infection with HIV

Roughly 30% 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 percent.

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 screen performed each time they start or stop a medication. Patients should tell their doctor and pharmacist about all the medicines they take, including prescription, over-the-counter, vitamins, and 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 that induce P-glycoproteins, such as St. John's Wort and rifampin may alter drug levels of Harvoni, so these should be avoided.

Do NOT stop medications on your own and remember to get that drug interaction screen.

Show Me the Money

There's no question that Harvoni is a blockbuster drug - at $95,000 per treatment regimen. According to Modern Healthcare, Gilead's revenue from Harvoni totaled $2.6 billion in the three months that ended June 30, 2016, down 29% from the same time in 2015. HCV treatment competition is stiff in the marketplace. However, the approval of Epclusa in June 2016 - which treats all major forms of hepatitis C virus - will provide a boost in sales for Gilead.

What about the future of Hep C and the new antivirals? It should be strong. Millions of people worldwide are still untreated or undiagnosed for HCV, with a need to be cured.

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 percent. 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. However, some experts state that these drugs are game changers: 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. However, 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, the center of the healthcare system; don't forget that.

So what are your thoughts about the new HCV oral treatments? Have you used them and what are your experiences? Consider joining the Drugs.com 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 and Harvoni. You CAN conquer HCV - empower yourself with health knowledge you need and stay well.

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

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Sources

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  • Newer Hepatitis C Drugs May Pose Health Risks: Study. Drugs.com. January 2017. Accessed 4/6/2017 at https://www.drugs.com/news/newer-hepatitis-c-may-pose-health-risks-study-64240.html

  • Rubenfire A. Lower Harvoni sales dampen Gilead's second-quarter profit. Accessed 4/6/2017 at http://www.modernhealthcare.com/article/20160725/NEWS/160729943
  • Pockros P, et al. Direct-acting antivirals for the treatment of hepatitis C virus infection. Up To Date. Accessed 4/6/2017 at https://www.uptodate.com/contents/direct-acting-antivirals-for-the-treatment-of-hepatitis-c-virus-infection#H1509303523
  • Gilead Announces U.S. FDA Priority Review Designation for sofosbuvir/velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection. Drugs.com. Jan. 4, 2016. Accessed 4/6/2017 at https://www.drugs.com/nda/sofosbuvir_velpatasvir_160104.html
  • American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Summary of Recommendations for Patients Who Are Initiating Therapy for HCV Infection by HCV Genotype. Updated July 6, 2016. Accessed 4/6/2017 at http://www.hcvguidelines.org/node/72
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