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September 11, 2015

Harvon + Solvadi + Olysio

Breakthrough Medications for Cure of Chronic Hepatitis C

In late 2014, the FDA approved release of the medication from Gilead Pharmaceuticals called Harvoni, and also approved a combination of two drugs from two different companies, the drug Sovaldi taken with the drug Olysio. Sovaldi (generic name sofusuvir) is actually one ingredient in Harvoni. Sovaldi and Olysio (generic name simeprevir), were previously approved for Hepatitis C treatment but were developed to be used with other drugs which were problematic because of their side effects—older drugs ribavirin, and interferon (injections). Based on new research, it was clear that the new medication, Harvoni, or the new combination, Sovaldi + Olysio, get superior cure rates (up to 99%!!), don’t require any injectable drugs, and don’t involve drugs that commonly caused significant side effects. These are FDA approved for Genotype 1 Patients.

Q & A

Who can get it and how to decide?

Should everyone with hepatitis c get these new treatments?

People with chronic hepatitis C have a disease that will not cure itself—once the virus is in the body, the body’s immune system doesn’t seem to have to the power to get rid of the virus. About one in three people who have the virus long enough—most commonly 30 or 40 years—eventually get so much liver damage they develop the condition cirrhosis, where the liver is badly scarred, and where liver malfunctioning starts to cause illness and complications other than just fatigue. Cancer of the liver (hepatocellular carcinoma) becomes a threat also when cirrhosis has developed. Early in the course of having hepatitis C, we can’t predict who will get these long-term complications.

So: in theory, yes, everyone with hepatitis c should get these new treatments

So: what’s the catch?

Basically it comes down to COST. These new treatments, which may only require 12 weeks of one pill daily (Harvoni) or two pills daily (Sovaldi+Olysio), cost about $100, 000. No insurance payer is willing to just allow “everyone” to get the treatments, since there are millions of Americans who have the disease, many of whom don’t know it. We are encouraging screening of anyone who is at high risk having hepatitis C.

So: what’s the strategy if not everyone can get treated now?

The requirement is to identify who has more serious liver disease... who has liver malfunctioning, who has indications they have cirrhosis, and who has disease that isn’t just stable and nearly harmless—about 2/3 of everyone with hepatitis C who even after 30-40 years of disease seem well with healthy livers. The professional societies of specialists in liver disease, AND the insurance plans which develop guidelines for who can get coverage for treatment, essentially agree on who should be treated and how we know who they are:

  • Individuals whose blood tests and physical exam findings indicate they have cirrhosis
  • Individuals who have unusual immune complications of chronic hepatitis C (footnote 1)
  • Individuals who have liver ultrasound results that show cirrhosis, even when blood tests may not indicate this
  • Some individuals who have diabetes and have one particular type of hepatitis C
  • Individuals whose ultrasound and blood work look good, but where other tests indicate there is a substantial amount of scar tissue in the liver.

In this situation—which means a large number of people—we have two fairly good ways of finding out who these people are:

--We can do a liver biopsy, a procedure that has very little risk and takes just a few minutes to perform, where a small bit of liver tissue is obtained for microscopic analysis (pathology evaluation). This is done as an outpatient, usually by a radiologist who uses ultrasound to guide the thin biopsy needle very quickly into and back out of the liver (lower right rib cage region) to get the tissue. The area is numbed before doing the biopsy, but there is brief pain to it. The pathologist examines the tissue. The report tells us what amount of inflammation is going on, and, most importantly, what amount of scar tissue is present—from a grade of zero for none, to a high grade where there is liver cirrhosis. We can get approval to treat those who have medium or more advanced grades of scar tissue, which is usually years before any symptoms or complications of liver disease are destined to occur.

Another diagnostic test includes a Liver Flastography(we’ll call it LE) (Fibroscan is one of the “brand names” for this test). It uses sound waves from a machine that is essentially an ultrasound machine, but instead of getting images, gets measurements of the stiffness of the liver, and the amount of stiffness relates to the amount of scar tissue. We can get approval to treat those who have medium or more advanced grades of scar tissue. Unfortunately, people who are obese cannot get accurate LE readings. LE as a procedure is not covered by insurance by some plans and is only now becoming available in the community, since equipment is very expensive and reimbursement is not necessarily very good.

So: what do we do to evaluate you and decide if treatment should be started?

Our medical history helps determine when you might have gotten hepatitis C, whether it is causing symptoms or has resulted in complications. Your physical exam gives us clues, especially if we find abnormal liver shape, texture, or enlarged spleen, or certain changes in the skin. Your blood tests will help us see whether the liver is malfunctioning seriously or whether there are indications of cirrhosis. Sometimes we run a panel of special blood work called a Fibrospect, which some insurance companies cover, costs a few hundred dollars, but sometimes gives us a good estimate whether there is more serious liver disease Your ultrasound scan gives us indications if liver disease is more advanced we may need you to get a liver biopsy; or we may advise a Fibroscan LE test if your plan will cover it or you are willing to pay ($300-400) out of pocket

If we decide with you that treatment should be started

  • We write a prescription for one or the other treatment
  • This goes to a specialty pharmacy that will help with the prior approval process to your health plan
  • We supply the information (history, exam, blood work, ultrasound, liver biopsy or LE test)
  • The plan decides whether you meet the criteria to allow for treatment to be paid for, and informs you about whether there is a copay that is affordable or unaffordable.
  • We can appeal a decision we think is unfair, if we think they are NOT following the guidelines. YOU can still appeal a denial also.
  • If treatment is unaffordable, the pharmaceutical companies have programs to decide if you qualify financially to get a subsidy, or free drug
  • If all goes well, you then get the medicine and we start treatment.

If we do treat you, here is the basic info you need to know about Harvoni.

QUES: Is this for all hepatitis C patients? At present, only for genotype 1 and selected patients with other genotypes of hepatitis C. If you have one of the other types we’ll discuss options; sometimes these medications still apply also.

1. Harvoni (Gilead Pharma) is a combination pill with two medications at the dose found to successfully treat hepatitis C: sofosuvir (“sof”) 400mg; and ledipasvir 90 mg (“led”). Both drugs work against the virus directly and the combination prevents your virus developing resistance to the drugs.

2. Treatment is taken in most cases for 12 weeks and it is essential to take every single dose, preferably the same time of day. Viruses can develop resistance quickly if the drug disappears from the body. This can be taken with our without food.

3. Who gets 12 weeks?

People who were never treated before, with or without cirrhosis People who tried but failed prior treatments, with no indication of cirrhosis Sometimes we will treat for only 8 weeks if the level of hepatitis C virus is fairly low (under 6 million IU/ml on the hepatitis C RNA quantitative test) and the genotype is 1b.

4. Who gets 24weeks?

People who tried but failed prior treatments, and who have indications of cirrhosis

5. Special cases

People with severe kidney disease, for example need kidney dialysis People who have HIV and also have hepatitis C

6. Precautions

Do not use St Johns wart or a type of TB drug called rifampin. These make the “LED” ineffective so treatment won’t work

7. Side effects are very few

The 10% or so of patients in the FDA trials who reported fatigue or headache had minor degrees of these and it isn’t clear the drug caused these, more likely they were just what the patients had anyway. Same with the very low rates reported of nausea, diarrhea or dizziness—these are just symptoms people get commonly for any reason.

8. Drug interactions: to get the best blood levels of Harvoni medications

a. If you need an antacid, keep it 4 or more hours away from the Harvoni b. If you need an acid controller like Pepcid, Zantac take at the same time, or 12 hours away, f rom Harvoni and don’t use more than 80mg of Pepcid (famotidine) or 300 mg of Zantac (ranitidine) per dayuvastatin. c. If you need omeprazole (Prilosec) type acid blockers (PPI drugs), common in people with GERD/reflux, the advice is taking only 20 mg and to take Harvoni and the PPI acid blocker together 30 minutes before first meal of the day. d. If you take the heart medicine digoxin, the blood level of digoxin might increase and it needs to be measured after 7-10 days on Harvoni to see if digoxin dose needs to be reduced. e. If you have to take certain seizure drugs then we shouldn’t use Harvoni, it will often be ineffective (carbamazepine , phenytoin , phenobarbital , oxcarbazepine ). f. Cholesterol drugs: Not advised to use Harvoni with Crestor (rosuvastatin), usually the statin can be dropped for 12 or 24 weeks with little harm, or a different low potency statin used instead. g. HIV drugs get special instructions. Sometimesis fine to use with Harvoni, with monitoring for side effects of tenofovir (Viread), sometimes best NOT to use Harvo.

9.Pregnancy Class B

Means use Harvoni if there is a good reason to and there are no indications it is harmful but we have very limited experience and can’t “prove”safety

10.Breast-feeding

Appears safe although small amounts of the drug likely do get to the baby

Testing for a Cure:

We measure the viral levels at 4 weeks to be sure drug is working and again at 12 weeks. In those taking it 24 weeks we measure again at 24 weeks, at end of treatment in either case. IT IS VERY RARE to detect any virus at end of treatment. We check again 12 weeks (3 months) after end of treatment: negative (no virus) means cure. Ordinarily we don’t need to run virus tests again. Note that the antibody test for hepatitis C, which is how you were first diagnosed, can still be positive longterm and there is no reason to check it.

Cure Rates:

94-99%, the lower number in those with cirrhosis who had failed prior treatment, and got 12 weeks of Harvoni. The cure rate is 98-99% in these people with 24 weeks of treatment.

What if I don’t qualify for treatment now?

In a sense, that isn’t entirely bad news….as much as we want to treat and cure everyone, it isn’t realistic right now to treat everyone. We hope that changes. But, if your liver isn’t bad, it usually means you have not just a few years without any serious problem but 10, 20 years or more, and a good chance you will never get serious liver disease. During that time, we’d figure drug options and costs will improve and everyone needing treatment will get treatment.

What to do in the meanwhile?

We advise yearly checkups with your primary care professional. This should include very limited bloodwork, namely a CBC (complete blood count, looks for anemia or dropping levels of blood platelets); and a CMP (complete metabolic panel), which looks at the common chemistry values including liver tests (the blood sugar, the calcium, the liver tests, the kidney function tests, the common blood minerals, are all in this). We will recommend the frequency at which a liver ultrasound should be done, and/or a test like LE (liver electrography e.g. Fibroscan).. We likely will want you to have a visit with us periodically---Yearly if you have no primary care checking you, perhaps about every 3 years if you get these tests and they are stable. This way if there are new treatment options, or the coverage criteria have gotten liberalized, we can try again to get treatment started. Obviously if your health declines from the liver disease, we re-evaluate and pursue treatment.

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