FDA approves Viekira Pak to treat hepatitis C

FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

“Health plans have been excitedly awaiting an alternative to the extremely costly Sovaldi for treating hep C,” said Don Hall, a former health plan CEO, is principal, Delta Sigma LLC, in Littleton, Colo. “I haven't seen any cost data on Viekira Pak to see if it will offer a lower cost alternative. That said, simply having a competitive treatment is likely to cut costs substantially.”

Express Scripts has announced that it will include Viekira Pak on its list of approved drugs for patients with genotype 1, the nation’s most common form of hepatitis C.

Viekira Pak contains 3 new drugs-ombitasvir, paritaprevir and dasabuvir-that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

Viekira Pak is the fourth drug product approved by FDA in the past year to treat chronic HCV infection. FDA approved simeprevir (Olysio, Janssen Pharmaceuticals) in November 2013, sofosbuvir (Sovaldi, Gilead Sciences) in December 2013 and ledipasvir and sofosbuvir (Harvoni, Gilead Sciences) in October 2014.

The approval of Viekira Pak is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of 6 pivotal phase 3 studies, which demonstrated that Viekira Pak cured 95% to 100% of GT1a and GT1b hepatitis C patients, including patients new and experienced to treatment, and patients with compensated cirrhosis, with less than 2% of patients experiencing virological failure. More than 98% of patients in clinical trials completed a full course of therapy.

Viekira Pak 's approval is also based on the results from phase 2 clinical trials, which showed that Viekira Pak cured 97% of liver transplant recipients and 92% of patients co-infected with HCV/HIV-1. Patients who achieve a sustained virologic response (SVR₁₂) are considered cured of HCV.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91% to 100% of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is 2 ombitasvir, paritaprevir, ritonavir 12.5-mg/75-mg/50-mg tablets once daily and 1 dasabuvir 250-mg tablet twice daily.

The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Viekira Pak is the 11th new drug product with breakthrough therapy designation to receive FDA approval. Viekira Pak was reviewed under FDA’s priority review program.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15% to 30% of these people will go on to develop cirrhosis.

"The approval by the FDA for the latest treatment for hepatitis C is welcome news," said Robert Taketomo, PharmD, MBA, president and CEO, Ventegra.

"However, the proclamation by one of the major PBMs that they intend to use this to treat 'all patients' may be a bit premature," Dr Taketomo said. "Most commercial PBMs are not at risk for prescription drug coveragw, they administer the claim cost on behalf of their clientele, so making a decision to cover treatment for 'all patients' without making a distinction on appropriate clinical use may not be in the best interest for the patient nor payer. Many hepatitis C patients remain asymptomatic, and social and behavioral issues must be addressed to prevent reinfection. Regardless of the discount, it can be expected that treatment, and possible re-treatment, for hepatitis C will remain a significant cost to the healthcare system.”

According to Hall: "The stock market is reacting to Express Scripts decision to add Viekira Pak to its National Preferred Formulary, a decision that will most likely be followed by other PBMs. This is a huge loss for Gilead Sciences who had a near monopoly with  Sovaldi. The assumption is that Express Scripts was able to get a much better negotiated price for Viekira than the high price of Sovaldi. This will undoubtedly be a big win for health plans who have been sweating the impact of treating hep C."