FDA Approves Two New Cost-Saving HIV Medications

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Having a chronic disease such as diabetes, asthma, COPD or HIV can cost a pretty penny. Since these diseases are not easy on the pocketbook, it’s not surprising that many Americans often times choose between eating and the paying the bills or being able to afford their medications.

In an effort to reduce the cost burden associated with HIV medications, Mylan Pharmaceuticals is introducing two new combination medications at a significant discount compared to competing products – Symfi Lo and Cimduo.

What is Symfi Lo indicated for?

Symfi Lo is a once-daily combination medication containing three drugs – efavirenz, lamivudine, and tenofovir. It is a single-tablet and is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 77 lbs.

Symfi lo will be available as a tablet in the strength of 400 mg/300 mg/300 mg. It is the first combination regimen in the U.S. with a reduced dose of efavirenz.  

Common side effects include rash and dizziness.

What is Cimduo indicated for?

Cimduo is a once-daily combination containing two drugs – lamivudine and tenofovir. It is indicated in combination with other medications for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 77 lbs.

Cimduo will be available as a tablet in the strength of 300 mg/300 mg.

When will these medications be available?

Both medications were approved by the FDA this February. Symfi Lo is expected to be available in the coming weeks, and Cimduo is expected to launch in the 2nd quarter of 2018.

Have there been any reports of serious side effects associated with Symfi Lo or Cimduo?

Yes. Lactic acidosis and non-alcoholic fatty liver disease, including fatal cases, have been reported with the use of lamivudine and tenofovir disoproxil fumarate.

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus and HIV who have discontinued lamivudine and tenofovir disoproxil fumarate.

How much will these medications cost? 

Mylan has not mentioned specifics, but they did mention that there would be a significant discount in a recent press release. You can read more about this press release here.

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