Harvoni

Ledipasvir/sofosbuvir

For Hepatitis C

Track record

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Short (approved in 2014)

Bottom line

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Hepatitis C

What is Hepatitis C?

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Hepatitis C is a disease caused by a virus that infects your liver. For some people with hepatitis C, the infection lasts only a short time and their body is able to get rid of the virus. However, most people infected with hepatitis C develop chronic hepatitis C.

Other treatments for Hepatitis C

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

More effective at clearing Hepatitis C virus from the blood than older treatments including interferon

All FDA reviewers (medical, statistical and virology) recommended approving Harvoni- a combination pill of ledipasvir and sofosbuvir (2 direct-acting antivirals) - for people who were never treated and who failed previous treatment. In the three main trials, 94% to 99% of people (with and without cirrhosis) taking Harvoni (without any other medicines for hepatitis C) had no virus in their blood 3 months after finishing treatment compared to about 60% seen in prior studies of people taking older treatments that included interferon. While FDA believes that no virus in the blood 3 months after treatment is a good indicator of benefit, others believe longer follow-up is needed to be sure the benefit is long lasting. FDA approved Harvoni alone since adding ribavirin (another Hepatitis C drug) did not make it more effective. And they approved a 12-week -instead of 8 week – course for people without cirrhosis because longer treatment was more effective. In November 2015, Harvoni was also approved for genotypes 4, 5, and 6 based on how many people had no virus in their blood 3 months after treatment. Of the 44 people with genotype 4, 93% had no virus. Of the 41 people with genotype 5, 93% had no virus. Of the 25 people with genotype 6, 96% had not virus. Because of the small numbers of people with cirrhosis or who failed prior treatment with genotypes 4, 5 and 6, there is uncertainty about how well Harvoni works in these people.

Avoid injections (interferon)

Harvoni is a once-a-day pill. Interferon – one of the drugs in other hepatitis C treatments – is an injection.

Fewer side effects because Harvoni can be taken without additional hepatitis C medicines such as Interferon or Ribavirin

Other hepatitis C medicines - Interferon and ribavirin - have more dangerous and more frequent bothersome side effects than Harvoni. In the approval trials, no dangerous side effects were seen with Harvoni (taken without other hepatitis C medicines). The most common symptom side effects were fatigue and headache. After approval, FDA has added a warning about dangerous slowing of the heart rate (bradycardia) when Harvoni is taken together with the heart rhythm drug, amiodarone (1 patient died from this combination, 3 patients required pacemakers).

FDA-approved use

To treat chronic hepatitis C (genotype 1, 4, 5, or 6) infection with or without ribavirin in adults

Who might consider taking it?

Adults with chronic hepatitis C (genotype 1, 4, 5, or 6) infection

People who have hepatitis C infection alone or have both hepatitis C and HIV-1 infection.

What is not known

Untested in children younger than 18 years

Untested in people with active symptoms of cirrhosis (decompensated)

If Harvoni will prevent you from infecting another person with Hepatitis C

To prevent infecting others, the Centers for Disease Control recommends that people with Hepatitis C NOT share personal items that might have blood on them (like toothbrushes or razors), NOT donate blood, organs or semen, cover sores on the skin to prevent spreading blood or secretions and be aware that there is a low but real chance of infecting sexual partners (which can be prevented with condom use). Hepatitis C is NOT spread by sneezing, hugging, holding hands, coughing, sharing eating utensils or drinking glasses or through food or water.

Track record

SHORT TRACK RECORD

Short track record means that new, unexpected side effects may emerge. Harvoni was approved by FDA in 2014 based on studies where about 1,100 people took the drug for up to 6 months. As with all new drugs, rare but serious side effects may emerge after Harvoni is on the market when larger numbers of people - with other conditions and on other medications - have used the drug.

Open questions

Ongoing studies FDA required to answer questions about benefit and harms

FDA is requiring the company to conduct additional studies to answer open questions about Harvoni’s long-term benefits in treating Hepatitis C. In addition, benefits and side effects are not known in people taking Harvoni for hepatitis C along with Atripla for HIV, with advanced liver disease or who have had a liver transplant. It is not known whether or not Harvoni can cause cancer in mice and rats, and whether or not Harvoni is effective in people who have resistant Hepatitis C viruses (NS5A or NS5B resistance substitutions).

Do not take if you...

Need to take ribavirin with Harvoni but have a reason you cannot take ribavirin

Ribavirin may be recommended with Harvoni in people with genotype 1 or who have cirrhosis and failed prior treatment. Do not take ribavirin if you are pregnant or planning to become pregnant, are a man whose female partner is pregnant, are allergic to ribavirin or its ingredients, have autoimmune hepatitis, have certain blood disorders (such as thalassemia major or sickle-cell anemia), have severe kidney disease (creatinine clearance less than 50), or take didanosine.

Safe if pregnant or breastfeeding?

Pregnant

No evidence that {Drug} harms baby (FDA Category B - second safest rating)

Breastfeeding

Unknown if Harvoni gets into breast milk

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