Gilead Files for FDA OK of New All-Genotype Hepatitis C Treatment

What is a Hepatitis C Genotype?

When a person is tested for hepatitis C, there is a series of three tests. The first test is to see whether the person has been exposed to the hepatitis C virus. If they test negative, that typically means they have not been exposed and no further testing occurs. If they test positive, they are provided with the second test. This is to tell whether the body has become infected with the hepatitis C virus. A negative test means that the person either never became infected even though they were exposed or it means their body fought off the infection on its own. A positive test result means the person currently has an active hepatitis C infection. When this occurs, the person is then given one final test, which is to determine which specific strain or genotype of hepatitis C the person has. There are six types and each responds differently to different medication. Knowing the virus’ genotype helps the doctor to prescribe the best medication to rid the body of that genotype of the virus.

Who is Gilead?

Gilead is a major drug company that manufactures hepatitis C medication. They have invented a new drug that is intended to be used to treat all six genotypes of hepatitis C.

Why Would the FDA Not Approve This Treatment?

The FDA (Federal Drug Administration) is a United States organization that decides whether a medication is safe and effective for the American public. They review the medical studies and tests completed by the drug company and the list of side effects experienced by the participants in the studies. They then decide whether the medication benefits outweigh the risks significantly enough to approve the drug to be available to the general public.

Why Would the FDA Approve This Treatment?

This drug is the first of its kind to be a once-daily pill to treat all six genotypes of hepatitis C. This could be life-changing for patients who are currently taking numerous pills and for those whose treatment plans include a required medication injection. In addition, this drug could lessen the time it takes to rid the body of hepatitis C, as patients are more likely to maintain a proper protocol when it is one pill per day than they are when there are numerous requirements many times per day. Lastly, the drug may be less expensive than other medication protocols for individuals and insurance companies since there are fewer pills and injections involved. This may lead to an increase in approvals for those in need of medical treatment for hepatitis C. Over time, a lessened rate of currently infected people can lead to a lesser rate of new infections, which can be impactful at a national and international level.

What Happens Next?

If the FDA does not approve this drug, they will provide Gilead with reasoning about why the drug was rejected. Then, Gilead can create new studies to address the FDA’s concerns. This can take months or years, depending on the issue. When the issues have been addressed, if they are proven to be safe for patients, Gilead will resubmit their request to the FDA for the drug to be reconsidered. This process may repeat indefinitely until either the drug is approved or until Gilead decides to instead focus on other drugs and not continue to pursue approval for this specific medication.

If the FDA approves this drug, the drug would then begin to be mass manufactured so it would be able to be in stock all across the country in local hospitals and pharmacies. This could take weeks or months, depending on the speed of the drug manufacturer’s staff and equipment. Then the drug is introduced to local hospitals and doctors so they can learn about it and decide whether they want to prescribe it to their patients who qualify. Simultaneously, health insurance companies will review the drug, its costs, and how it compares to similar drugs and decide whether they will cover any or all of the cost of the drug if their insured customers are prescribed that drug. At that point, a patient can begin to discuss the drug with their doctor to find out whether it is the right fit for them. If they and their doctor agree, the doctor will write the prescription, the insurance company will approve the cost, and the pharmacy will provide the medication to the patient. If you think this drug might be right for you, you can discuss it with your doctor, who will help you to understand whether this is a better option than your current prescription.1-3

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The HepatitisC.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.
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