Hepatitis C is a viral disease that causes inflammation of the liver. The hepatitis C virus (HCV) spreads through contaminated blood. Until recently, HCV was treated with medications that had numerous side effects and limited success rates.

However, AbbVie – a global pharmaceutical giant – has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for a new drug offering tremendous potential in treating HCV. This article will explore the key features of this new drug and what it means for the future treatment of Hepatitis C.

What is HCV?

Hepatitis C is a viral infection that attacks the liver, which is a vital organ responsible for removing toxins from the body.

HCV spreads through contaminated blood or body fluids, and it’s estimated that approximately 3 million people in the United States are living with HCV.

Some of the common risk factors for HCV include sharing needles or other drug injection equipment, getting a tattoo or piercing with a contaminated needle, sharing personal care items such as razors or toothbrushes with an infected person, being born to an HCV-infected mother, and having unprotected sex with an infected person.

Current Treatment for HCV

The treatment of Hepatitis C has evolved significantly since the introduction of the first HCV antiviral drug, interferon, in 1991.

Traditionally, patients received injections of interferon and ribavirin, which had limited success rates and many side effects, including fatigue, nausea, depression, anemia, and hair loss.

In recent years, direct-acting antiviral (DAA) drugs have emerged as the most effective treatment option for HCV.

DAAs are more effective than interferon-based therapies, have fewer side effects, and can be used to treat different types of HCV infections. Popular DAAs in use today include Sovaldi, Harvoni, and Epclusa.

Despite their efficacy, DAAs require long-term treatment – up to 12 weeks or more. They are also expensive, sometimes costing as much as $1,000 per pill. As a result, many people with HCV do not have access to these life-saving medications.

AbbVie’s New Drug Application

AbbVie submitted a new drug application (NDA) to the FDA for an experimental HCV drug called uprifosbuvir (MK-3682B), previously referred to as ABT-530. The drug is a combination of two DAAs – uprifosbuvir and the polymerase inhibitor ruzasvir.

The hope is that uprifosbuvir will offer more effective treatment for HCV in much shorter timeframes. Clinical trials have indicated the new drug has a significantly high cure rate in just eight weeks, requiring only one pill per day.

Additionally, it’s reported that the new drug offers a sustained virologic response (SVR) at 12 weeks after treatment is completed. If the FDA approves the new drug, it will be the first once-daily HCV medication that offers an eight-week treatment regimen.

Clinical Trials

A Phase II clinical trial was conducted by AbbVie to investigate the dosing regimen and evaluate the safety, pharmacokinetics, and efficacy of uprifosbuvir plus ruzasvir in patients with chronic genotypes 1-6 HCV infection.

The study involved 341 patients and was conducted in 18 countries to evaluate the safety and efficacy of the drug.

According to the company, the combination therapy achieved a sustained virologic response of 96% after just eight weeks of treatment and 100% for those treated for 12 weeks. The most commonly reported side effects were fatigue, headache, and nausea.

AbbVie’s Impact on Hepatitis C Treatment

AbbVie has been a leading player in the area of Hepatitis C treatment, with its previous HCV treatments achieving promising SVR rates. Its Viekira Pak, a four-drug combination, showed an SVR of 100% in genotype 1a patients when used over 12 weeks.

However, unfavorable reimbursement policies, drug costs, and lack of efficacy in treating other genotypes led to the discontinuation of this medication by AbbVie.

With the submission of the new drug application for uprifosbuvir, AbbVie is looking to address some of the shortcomings of current treatments.

The potential for short-term and affordable therapy will be life-changing for patients with HCV and will likely improve the public’s general awareness of HCV, the benefits of early testing, and the availability of effective therapy.

Final Thoughts

The submission of a new drug application by AbbVie offering eight weeks’ treatment for Hepatitis C is among the most significant milestones in HCV treatment development.

If approved by the FDA, this will provide a significant boost in the fight against Hepatitis C, offering life-saving therapy, reducing side effects, and reducing the overall cost of treatment. AbbVie’s new drug has the potential to set the standard of care offering more HCV treatment options and bringing us closer to a world free from Hepatitis C.