Hep C and Harvoni: 11 Facts About Your Treatment
Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 25, 2022.
HCV and Harvoni: Interferon-Free
Many newer treatments for chronic hepatitis C virus (HCV) -- a blood-borne infectious disease -- have been the focus of ongoing research.
HCV can lead to:
- chronic liver disease
- liver inflammation and scarring
- liver cancer
- eventual liver transplant
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?
What Exactly is Harvoni?
Chronic hepatitis C virus (HCV) treatment has come a long way -- very quickly. In fact, in 2012 the typical treatment for HCV 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 comes as:
- oral tablets that contain ledipsavir and sofosbuvir: 45/200 mg or 90/400 mg strengths
- oral pellets that contain ledipsavir and sofosbuvir: 45/200 mg or 33.75 mg/150 mg. Harvoni oral pellets can be taken right in the mouth without chewing, or with food. Harvoni pellets are used in pediatric patients who cannot swallow the tablet formulation.
Harvoni is indicated for the treatment of adults and children 3 years of age and older with chronic hepatitis C virus (HCV):
- genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin
- genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
Review the complete Harvoni dosing here.
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 and sofosbuvir) can be used for genotype 1, occurring in roughly 70% of infected patients, as well as types 4, 5 and 6.
- Epclusa (sofosbuvir and velpatasvir) is a "pan-genotypic" once-daily HCV drug that was approved in June 2106 and is indicated for all HCV subtypes 1-6.
More about Epclusa
Epclusa (sofosbuvir / velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination that treats all major HCV genotypes 1 through 6:
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis for use in combination with ribavirin.
- It is approved for adults and children 3 years of age and older. Dosing in children is weight based. It is also used in patients with HCV/HIV-1 coinfection.
Epclusa is available as an oral tablet (400 mg/100 mg or 200 mg/50 mg) given once daily for 12 weeks (with or without ribavirin based on liver function), OR as an oral pellet formulation (200 mg/50 mg or 150 mg/37.5 mg per packet) for children who cannot swallow tablets. In children under 6 years of age, give the oral pellets with food to inprove palatability. Epclusa oral tablets are not used in patients weighing less than 17 kg.
What to ask my doctor?
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.
You'll also need to be tested for evidence of hepatitis B virus (HBV) infection before initiating HCV treatment with Harvoni.
- Many 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.
- In addition, many HCV treatments are covered by insurance or Medicare.
- Harvoni is now available as an authorized generic option for the higher strength tablet, but can still run over $10,000 per month for the cash price. Prices may vary and you can print discount coupons here. The brand name price is over $32,000 per month.
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 Treatment Option
Harvoni is one recommended first-line option for HCV in guidelines and clinical decision support resources. 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 genotype 1 patients with low amounts of virus in their blood (pretreatment HCV RNA less than 6 million IU/mL), and no cirrhosis, 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 and dosing information.
- Children 3 years of age and older will also take Harvoni (dose is based on their weight) for 12- or 24-weeks based on previous treatment experience and presence of liver disease. Harvoni oral pellets can be used by smaller children who cannot swallow the tablet formulation.
Other options include: Mavyret, Epclusa, Zepatier and others, based on liver function, age, and if it's your initial or later treatment.
Learn more: How should I give Harvoni pellets to my child?
Harvoni Dosing and Side Effects
Harvoni is given by mouth 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. Tablets or oral pellets are available. Do not chew Harvoni pellets.
The recommended dosage of Harvoni in children 3 years of age and older is based on their weight.
Usually, the side effects that occur with Harvoni are mild, but can vary based on your treatment regimen. 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 10% of patients include:
- asthenia (lack of energy)
In addition, all patients should be tested for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with Harvoni. As noted in a Harvoni boxed warning, HBV reactivation has been reported, in some cases resulting in fulminant hepatitis (severe and rapid liver disease), liver failure, and death.
Co-Infection with HIV
Up to one-third of patients with HCV also have HIV in the U.S. Co-infection can increase the risk for advanced liver disease (cirrhosis), end-stage liver disease, and liver cancer.
Harvoni is also approved 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%.
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:
- herbal supplements.
Drug Interaction Concerns with Harvoni
Harvoni has many possible drug interactions.
- Healthcare providers assess the potential for Harvoni drug interactions prior to prescribing.
- Patients should tell their doctor and pharmacist about all of the medications they take, including over-the-counter (OTC) medicines, herbal products, vitamins or any dietary supplements.
- Patients should remember to get a drug interaction review with each new or discontinued drug while taking Harvoni.
A slowed heart rate (bradycardia) can occur in patients who take Harvoni in combination with amiodarone (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.
- Use of Harvoni with amiodarone is not recommended. If you have no other options for treatment, your doctor will monitor your heart function closely.
Other drug interactions (this is not a complete list)
- Harvoni should not be used with other drugs that also contain sofosbuvir (Epclusa, Sovaldi, Vosevi)
- Medicines such as St. John's Wort (an herbal drug bought over-the-counter and used for depression) and rifampin (both are P-gp inducers) may alter drug levels of Harvoni, so using P-gp inducers with Harvoni is not recommended.
- If you take the blood thinner warfarin, frequent monitoring of your international normalized ratio (INR) values is recommended.
- Lab parameters may also need to be followed for glucose (blood sugar) control in certain patients as well as in patients that take drugs where small differences in blood concentrations can lead to toxicty or a lower therapeutic effect (these drugs have a narrow therapeutic index).
HCV: Show Me the Money
There's no question that Harvoni is a blockbuster drug. In fact, all of the new HCV oral agents are very expensive and usually out of reach for patients without adequate insurance. If you are not able to afford your medications, be sure to contact Gilead, the manufacturer and ask about any available Patient Assistance or CoPay Card Programs.
It may be worthwhile to check with your health insurance before you and your doctor decide upon Harvoni as your treatment of choice to be sure it is a preferred regimen. Most insurance plans and Medicare are now inlcuding oral direct-acting HCV agents on their formulary (which is a list of medications they will or won't pay for).
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 treatment price tag for Harvoni is a hard pill to swallow. Many consider the costs of these new oral HCV 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. Plus, authorized generics are now available for some oral agents, helping to lower costs for insurance and patients
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 Drugs.com Hepatitis C Virus Support Group to voice your opinion and lend facts to the discussion.
Finished: Hep C and Harvoni: 11 Facts About Your Treatment
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- HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. ISDA, AASLD. Treatment-Naive Genotype 1a Without Cirrhosis. Accessed Aug 25, 2022 at https://www.hcvguidelines.org/
- Harvoni [package insert]. 3/2020. Gilead Sciences, Inc. Accessed Aug 25, 2022 at https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
- Pockros P, et al. Direct-acting antivirals for the treatment of hepatitis C virus infection. Up To Date. Accessed Aug 25, 2022 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 Aug 25, 2022 at https://www.drugs.com/nda/sofosbuvir_velpatasvir_160104.html
- Muir A, et al. Treatment regimens for chronic hepatitis C virus genotypes 4, 5, and 6 infection in adults. Up To Date. Accessed Aug 25, 2022 at https://www.uptodate.com/contents/treatment-regimens-for-chronic-hepatitis-c-virus-genotypes-4-5-and-6-infection-in-adults
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