What You Need to Know About Current HCV Medications

Potent New HCV medications

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 FDA approved treatments for hepatitis C date back to the early 1990’s when interferon-alfa became available as a three-times weekly injection for HCV.  Over the next twenty years, interferon or its modified derivative, peginterferon with or without oral ribavirin, was the standard of care for treating hepatitis C. Interferon worked indirectly on the virus by augmenting the natural antiviral responses of the person infected.

This therapy was difficult to tolerate, involved frequent injections for up to one year, and had a success rate of only 6%-54%.  Clearly, better treatments were required.

In 2011, the FDA approved the first medications which acted directly on the virus replication machinery.  These were the HCV protease inhibitors: boceprevir and telaprevir.  They were effective in stopping viral replication, but because of ​the emergence of viral resistance to the medications, they needed to be administered along with peginterferon and ribavirin. So in spite of the fact that success rates climbed to 69%-74%, the side effects of the triple drug combination became intolerable to many patients. These medications are no longer used in the United States today.

The first major breakthrough came in 2013 with the approval of sofosbuvir and simeprevir. Although each was initially approved for use with peginterferon for genotype 1, off-label use of the two in combination without peginterferon, soon became a major use.

Success rates approached 90% or higher; and avoiding interferon meant that the therapy was well-tolerated for the 12-24 weeks of treatment duration. However, these agents were quite expensive and some less common strains and conditions of hepatitis C still required peginterferon (EXPENSIVE MEDICATIONS).

That remained the status of HCV treatment until October 2014 with the approval of a single tablet formulation of the combination of sofosbuvir and ledipasvir (HARVONI).  This combination tablet was highly effective in genotypes 1 and 4 without the necessity of peginterferon or ribavirin. It remains the most prescribed therapy for hepatitis C in the United States. There are, however, some important cautions.  Since sofosbuvir should not be administered to patients with severe kidney dysfunction (creatinine clearance less than 30 mL/min), this single tablet formulation has the same restriction. Also, the medication should not be administered to those who also take Amiodarone, a cardiac rhythm medication. Proton pump inhibitors (Prevacid, Neium, etc.) may decrease efficacy of this medication and should be co-administered.

A few later in 2014, AbbVie announced the FDA approval of their three drug combination called Viekira Pak (VIEKIRA PAK).  This combination contains two, once daily, co-formulated medications: Ombitasvir and Paritaprevir and a twice daily medication Dasabuvir.

  The Paritaprevir is also co-formulated with a booster medication, ritonavir, to enhance the potency of the Paritaprevir. Finally, for genotype 1a infections, this combination is given with twice daily ribavirin. This combination is highly potent in genotype 1 infections with or without cirrhosis. This combination is safe and effective in patients with well-compensated cirrhosis, but may not be safe for those with evidence of decompensation (Warning)(What kills patients with cirrhosis?). The main drawbacks to this therapy are some troublesome drug-drug interactions due to the ritonavir and the number of pills that need to be taken each day.

As of the end of 2015, the newest medication approved by the FDA is Daclatasvir (DACLATASVIR). This is a medication with a broad HCV genotype reactivity similar to sofosbuvir but is of a different class of medications, so giving these two medications together may allow virtually all HCV genotypes to respond without use of peginterferon or ribavirin, but is recommended for genotype 3 specifically. There are, however, drug-drug interactions with Daclatasvir, so consultation with a doctor or pharmacist is recommended.

Two other newer hepatitis C medications are anticipated in early 2016.  These will be the subject of an upcoming report.You may also find information on hepatitis C from the American Liver Foundation (ALF)

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