What Is The Process For Approving Hepatitis C Drugs?
Drug approval for medications to treat or cure hepatitis C are the same as for any other medications; years or sometimes decades and millions of dollars are spent by pharmaceutical companies each year to research, creates, and test drugs to treat or cure illnesses. If the drug passes each level of this process, it is eventually submitted to the government’s drug approval department (in the US, this is the Federal Drug Administration or FDA). If the drug is approved, it can take a short while for the manufacturers to produce the drug and get it stocked at pharmacies. At the same time, drug representatives are traveling throughout the nation to train doctors on the benefits of that drug and marketing plans are rolling out to encourage doctors and patients to discuss the new drug at the time of treatment planning.
Why Was A New Drug Needed?
Before Epclusa, the process of hepatitis C testing involved a number of medical tests after the person tested positive for the hepatitis C virus. These tests included bloodwork to find out the genotype or strain(s) of the hepatitis C virus present and liver testing to find out whether the virus had caused damage to the liver. If the liver was damaged, additional testing occurred in order to find out the extent of the damage, which may include cirrhosis of the liver. Medical interventions were individualized based on the patient’s viral genotype and on their liver function and health. In some cases, the drugs that worked best for one genotype could not be prescribed because of the patient’s liver health, creating a difficult and frustrating situation for the patient and for the doctor.
As different patients were on different medications, they were also experiencing a wide variety of side effects. Sometimes this meant altering the drug treatment plan. In addition, many of the medications were too expensive for many to afford.
What Makes Epclusa Better Than Other Drugs?
Epclusa is fixed-dose combination of sofosbuvir and velpatasvir. It is a completely different experience for people with hepatitis C. Epclusa treats hepatitis C genotypes 1, 2, 3, 4, 5, and 6 (all of the currently known genotypes), as well as being approved for patients with healthy livers and those who have been diagnosed with cirrhosis. This significantly streamlines the treatment plan for many doctors’ offices and clinics. In addition, the cost of beginning to treat hepatitis C can be cut significantly, as testing for genotype and testing for liver function are no longer necessary with Epclusa. In addition, Epclusa is priced far below the pricing of alternative medications. The combination of these facts make Epclusa very interesting to physicians, especially because the lower pricing may lead the manufacturers of other hepatitis C drugs to lower their prices in order to remain competitive, which benefits many whose budgets and insurance companies do not currently afford them access to some of the current hepatitis C medications on the market.
Is Epclusa right for me?
Although it may appear that Epclusa is a wonder drug or miracle, it is a drug. This means that only your doctor can help you to decide if it is the right drug for you. Although there are enough benefits to this drug for the FDA to have approved it for use, it, like all hepatitis C medications, does have the risk of side effects. These are similar or the same as the side effect risks for other hepatitis C drugs. Some of these include tiredness, irritability, insomnia, headache, nausea, and depression. In addition, though Epclusa is less expensive than its competitors, it is still very expensive, at an estimated price for treatment of $75,000. This may mean that your budget or your insurance company will not be able to afford Epclusa as a treatment option. In addition, as is true with any new drug, long-term side effects are not yet available. As is true with any drug or treatment option, the only way to know whether Epclusa is right for you and your medical needs is to discuss it with your doctor. Together, you can discuss what medication options make sense for your body’s needs, as well as which side effects are the least detrimental to your lifestyle or are the least likely to occur. You can plan for how you will manage side effects if they happen, and you can work together to create a treatment regimen that encompasses medication, diet, exercise, and any other recommendations your doctor has, based on the needs of your body.1-5
Epclusa New FDA Drug Approval | CenterWatch. (2016). Centerwatch.com. Retrieved 24 July 2016, from https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100157/epclusa-sofosbuvir-and-velpatasvir-
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection. (2016). Fda.gov. Retrieved 24 July 2016, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm
FDA approves first pill to treat all forms of hepatitis C. (2016). Cbsnews.com. Retrieved 24 July 2016, from http://www.cbsnews.com/news/fda-approves-first-drug-epclusa-to-treat-all-forms-of-hepatitis-c/
Omudhome Ogbru, P. (2016). Epclusa for Hep C: Side Effects & Prescribing Information. MedicineNet. Retrieved 24 July 2016, from http://www.medicinenet.com/epclusa_sofosbuvir_and_velpatasvir/article.htm
U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C | Gilead. (2016). Gilead.com. Retrieved 24 July 2016, from http://www.gilead.com/news/press-releases/2016/6/us-food-and-drug-administration-approves-gileads-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-all-genotypes-of-chronic-hepatitis-c