An Expert Discusses Hepatitis C Drugs and Eligibility
August 15, 2015
We live in the golden age of hepatitis C cures. But, even with such great drugs available, there are still a few hurdles and complications when it comes to knowing which regimen is right for you. You may not be eligible for treatment under these drugs, you may need to take more than one course of treatment or you may only be eligible for one "preferred regimen" under your insurance.
TheBody.com spoke to Maribel Rodriguez-Torres, M.D., a hepatitis C expert, to answer some of the most pressing questions on the complicated infection that is hepatitis C. After reading her answers about hepatitis C treatment, you may want to speak to your own doctor about what's the appropriate treatment for your hepatitis C.
I heard that the U.S. Food and Drug Administration (FDA) might approve additional hepatitis C drugs soon. If I were not eligible for treatment now, would those new drugs be right for me?
The best way to answer that question would be to ask your physician about your particular case. You should be aware of new drugs that are about to be approved, especially if you fit into a more difficult to treat category, like genotype 3 and cirrhosis. Most patients can be treated effectively with the drugs that are already approved. However, some patients, such as genotype 3 patients, might be better off with a drug combination that includes the drug called daclatasvir (Daklinza). This drug is approved in Europe and Japan, but not yet in the U.S. There is also a two-drug combination consisting of MK-5172 and MK-8742 that might work for these patients, but these drugs are not approved. This combination was submitted to the FDA for approval and may be in the market at the end of the year or early 2016.
Your doctor is the best person to tell you if you can afford to wait. Some genotype 3 patients have a much-damaged liver or other health problems, and they cannot afford to wait months for a new drug to be approved. There are excellent alternatives for the therapy of cirrhotic patients now. Patients with cirrhosis should consider therapy when stable or compensated to prevent progression to end-stage liver disease.
Why is it that most people take drugs for 12 weeks, but some people take drugs for 24 weeks, and others only for eight weeks? Am I eligible for eight weeks?
The only drug that is approved to be used for a duration of eight weeks is sofosbuvir/ledipasvir (Harvoni), and only a select group of patients can be cured after taking the drug for such a short amount of time. In clinical trials, it was demonstrated that patients with very little HCV RNA detected in their blood (less than 6 million IU/mL copies) didn't have any extra benefit from taking the drugs for 12 weeks, as opposed to just eight weeks. Therefore, eight weeks of treatment is only an option for patients with a viral load of 6 million copies or less with this particular drug combination.
My insurance company said I am only eligible to be treated with one of the approved drugs -- Viekira Pak -- but I have only heard about Sovaldi in the news. What are the differences between these drugs?
Viekira Pak was the second of this new class of drugs to be approved. While it does offer the same cure rates as Sovaldi for most indicated patients, in my opinion, it doesn't bring any new advantage to patients. In fact, some argue Viekira Pak is more cumbersome because it consists of multiple pills, and has more potential for interactions with other drugs.
Even though the drugs are not exactly the same, each pharmaceutical company is offering significant rebates and discounts to the different insurance companies if their drug is the "preferred" combination used. Therefore, some insurance companies have assumed the position that they will only pay for one drug, in exchange for discounted prices.
These drugs combinations are very expensive and this has caused many difficulties for patients. Patients have a hard time trying to obtain therapies paid for by insurance companies, anywhere. I do want to emphasize that regardless of your insurance provider, the most important relationship that you, as the patient, need to have is with your doctor -- great communication is vital. If you have a good doctor, he or she will do everything possible to make sure you get the best drug combination for your condition. There are usually exceptions to the insurance company's rules. You need to find a doctor with a dedicated staff willing to fight for you.
Maribel Rodriguez-Torres is the founder and president of Fundación de Investigación (FDI), the largest clinical research center in Latin America. She received both her M.D. and her postgraduate fellowship at the School of Medicine of the University of Puerto Rico. She dedicates much of her time today to working with the government to increase access to treatment for patients without health insurance.
Sony Salzman is a freelance journalist reporting on health care and medicine, who has won awards in both narrative writing and radio journalism. Follow Salzman on Twitter: @sonysalz.
This article was provided by TheBody.com.
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