AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

In continuation of my update on Dasabuvir,  ombitasvir, paritaprevir and ritonavir

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.

 dasabuvir    ombitasvir

Paritaprevir  ritonavir

Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for Viekira Pak which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100 percent cure rates in genotype 1b patients."

There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2

The approval of Viekira XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received Viekira Pak with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulations.

About Clinical Studies

The components of Viekira XR (administered twice daily with a meal) have been studied in seven Phase 3 clinical trials where 1076 subjects (including 181 with compensated cirrhosis) received the recommended regimen of Viekira +/? RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis. Ninety-five to 100 percent achieved SVR12, which means the hepatitis C virus is not detectable in the blood three months after treatment ends. Cure rates varied by the subtype of hepatitis C and whether or not the person had cirrhosis. Individual results may vary.

USE

Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets/Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) (Viekira) are prescription medicines used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection.

Viekira can be used in people who have compensated cirrhosis.

Viekira is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking Viekira.

About Viekira XR

The components of Viekira XR* have been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naïve to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV).

The extended-release co-formulation of these components, Viekira XR, consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet, and is dosed three tablets once daily. Viekira XR must be taken with a meal, and tablets should be swallowed whole. People should not drink alcohol within four hours of taking Viekira XR. Viekira XR is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. Viekira XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients and in all patients who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie's ombitasvir with or without dasabuvir for the treatment of hepatitis C.

*Given as a fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal.

VIEKIRAX and EXVIERA achieve high SVR rates in GT1 and GT4 hepatitis C virus infected patients

ombitasvir

paritaprevir

ritonavir 

dasabuvir 

ribavirin (RBV).

AbbVie, a global biopharmaceutical company,    announced new real-world data showing 96 percent of genotype 1 (GT1) patients (n=486/505 assessable for analysis) and 100 percent (n=53/53) of genotype 4 (GT4) patients achieved sustained virologic response at 12 weeks post-treatment (SVR12). These data support results seen in Phase 3 clinical trials for chronic GT1 or GT4 hepatitis C virus (HCV) infected patients treated with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV).

The analysis also reports safety outcomes from 1,017 people with GT1 or GT4 chronic HCV enrolled in the German Hepatitis C-Registry (DHC-R) who have initiated treatment, representing a diverse group of patients seen in real-world settings being treated with VIEKIRAX and EXVIERA. The results will be presented orally today at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

“Real-world studies complement randomized controlled trials and help to further enhance our knowledge of VIEKIRAX and EXVIERA in everyday clinical practice,” said Heiner Wedemeyer, M.D., research group leader, department of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany. “The effectiveness and safety results shown across a broad cross-section of patients in this particular study provide helpful insight into treatment of real-world patients.”

The safety study population (n=1,017) was reflective of a diversity of patients seen in routine clinical practice, including patients with cirrhosis (22 percent) and those previously treated for HCV (59 percent). More than half of patients (59 percent) were taking medicines for other medical conditions.

“These results provide additional insights that complement the Phase 3 clinical trial data for VIEKIRAX and EXVIERA,” said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. “We believe further ongoing real-world studies across multiple countries will enrich our understanding of HCV treatment.”

Among the patients included in the safety analysis (n=1,017), the rate of discontinuation due to adverse events (AEs) was low (1.5 percent).1 The most common AEs (≥ 5 percent) were fatigue (24 percent), pruritus (10 percent), headache (9 percent), insomnia (6 percent) and nausea (5 percent). Serious AEs were reported in 1 percent (n=5/480) of patients receiving VIEKIRAX and EXVIERA without RBV and in 3 percent (n=16/537) of patients receiving VIEKIRAX and EXVIERA with RBV. Fifteen patients discontinued treatment due to AEs, while two patients died due to myocardial infarction or stroke, respectively. Both cases were assessed as not related to study treatment.

VIEKIRAX and EXVIERA achieve high SVR rates in GT1 and GT4 hepatitis C virus infected patients: AbbVie, a global biopharmaceutical company, today announced new real-world data showing 96 percent of genotype 1 (GT1) patients (n=486/505 assessable for analysis) and 100 percent (n=53/53) of genotype 4 (GT4) patients achieved sustained virologic response at 12 weeks post-treatment (SVR12).

New drug combination may reduce need for complex regimens to treat hepatitis C

In continuation of my update on sofosbuvir

  

The prognosis for people with hepatitis C has improved dramatically in the last few years, thanks to the introduction of direct-acting anti-viral medications, including Harvoni (the brand name for a combination of ledipasvir and sofosbuvir) and Viekira Pack (a mix of ombitasvir, paritaprevir, ritonavir and dasabuvir). These drugs — which block the hepatitis C virus from multiplying — boast cure rates of better than 90 percent. In addition, they are well-tolerated in most patients, causing only minor side effects.

Despite these major advances, the quest for better hepatitis C medications is not yet over. Drug makers continue to test new drugs to overcome limitations in treating this virus, which can cause liver cirrhosis (or scarring) and failure. About 2.7 million people in the U.S. are infected with the virus, with nearly 30,000 cases occurring in 2013 alone, according to the Centers for Disease Control and Prevention.

"The current medicines are very effective, but physicians sometimes have to tailor the regimen or the length of treatment based on patient characteristics, such as whether the patient has liver cirrhosis or has failed prior therapy," says Nancy S. Reau, MD, chief of the Section of Hepatology at Rush University Medical Center.

Another treatment factor is the type of hepatitis C a patient has. The virus has six different strains, called genotypes.

Now a simplified way of treating all hepatitis C patients may be approaching. Reau participated in a phase III clinical trial of a combination of Solvadi (sofosbuvir) with the investigational drug velpatasvir on patients with genotypes two and three. As described in an article published online on Nov. 17 in the New England Journal of Medicine, the study found that 12 weeks of sofosbuvir-velpatasvir produced higher cure rates in patients with these two genotypes — including those who had cirrhosis or had failed older treatments — than a similar therapy (sofosbuvir-ribavirin)

New drug combination may reduce need for complex regimens to treat hepatitis C