Near-Perfect Cure Rate for New HCV Medication in People with Genotype 2

What is a Genotype?

A genotype is the specific genetic strain of hepatitis C that a patient has. At the time when a patient tests positive for being exposed to and having the virus, a doctor then tests the patient to find out their specific genotype. This allows the doctor to know which medications to consider for the patient’s treatment plan. This is because, traditionally, different medications work differently and most are targeted toward a specific genotype, causing the treatment options to be different for someone with one genotype than a patient would have if they had a different genotype of the hepatitis C virus.

Why is Glecaprevir/Pibrentasvir So Unique?

The Glecaprevir/Pibrentasvir combination medication is not yet approved by the American Federal Drug Administration (FDA), but has shown great promise in clinical trials. Although many more recently marketed hepatitis C medications boast a 95%+ cure rate after 12 weeks of daily treatment, this specific combination provided an almost perfect rate (99%+) for both those who had previously been treated with other medications and those whose virus had never been treated. In addition, there were no major side effects seen during clinical trials, which is a much better result than some of the nastier side effects that some experience with other medications. The only side effects reported were headache and/or fatigue, which only approximately 12% of test subjects experienced. As some patients’ side effects are worse than the effects of the actual virus and because these concerns can often require a patient to need additional medications to counteract those side effects, this medication may be seen as a great alternative, which can lower the need for side effect minimizing medications on top of being more effective against the virus itself.

What Happens Next?

New research indicates that Glecaprevir/Pibrentasvir is equally effective for other genotypes, though it was initially proven effective only for genotype 2. In a research trial of over 2300 test participants in 27 countries, the study included participants who had hepatitis C genotypes 1-6. It also included people with cirrhosis, without cirrhosis, with significant kidney disease, and those who had previously been on a different treatment medication which was ineffective for them. In short, this drug combination was effective at a 97%+ rate across all genotypes, even when considering the typical medical concerns and complications that lead other medication interventions to be unsuccessful. In addition, the most common side effect was fatigue, though some of those with cirrhosis also experienced itchiness and/or nausea.

AbbVie, the maker of the drug combination, has applied to the American Federal Drug Administration (FDA) for approval. This process may take months, as the program requires strict review of the drug, as well as each individual trail. If the FDA finds incomplete evidence of efficacy, it can ask AbbVie to complete more testing or more research studies and then apply for reconsideration. If the FDA finds problems with the testing or research, it may require AbbVie to provide new information or review their numbers and reapply for approval. However, it is AbbVie’s hope that the FDA will approve this drug combination.

If that happens, AbbVie will begin to mass produce the drug, in anticipation of sales. The drug will then be sent to pharmacies, nationwide, in preparation of filling prescriptions. At the same time, a marketing department may begin to run television advertisements or send samples and other marketing material to doctors. Doctors will then begin to consider whether this new drug is better in some way than what they have been previously been prescribing to patients.

How Might This Affect My Treatment Plan?

If you are already on a hepatitis C medication treatment plan, you can discuss this medication with your doctor if you have questions about whether it might be a better fit for you than your current treatment. If you have not yet begun treatment, you can discuss this medication and your doctor can help you to understand either why it is an option for you or why another medication may be a better fit for your medical needs.

In addition to talking with your doctor, you may need to discuss this medication with your health insurance company. While new medications become available all the time in the healthcare industry, insurance companies do not always provide coverage for new medications right away, if at all. Sometimes this is because their coverage decisions may be a lengthy process. Other times, it is because they determine that other, already existing medications are effective enough that a newer, often higher priced medications are unnecessary for them to cover. This can leave the patient to choose between another medication that is covered and purchasing the newer drug with their own money. If you are new to treatment or if you are considering requesting to switch medications, you may wish to discuss your options with your insurance company in advance, so that you and your doctor can choose a medication treatment plan that both meets your medication needs and still qualifies for the lowest possible out of pocket costs.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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