How does Viekira Pak compare to Sovaldi

Viekirax for hepatitis C.

Viekirax is a combination preparation consisting of the active ingredients ombitasvir, paritaprevir and ritonavir. It was developed for the treatment of chronic hepatitis C.

EU approval recommendation for Viekirax for hepatitis C.

11/21/2014 The Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) recommends Viekirax (active substances ombitasvir [12.5 mg], paritaprevir [75 mg] and ritonavir [50 mg]) film-coated tablets from AbbVie Ltd for the treatment of chronic hepatitis C. to be allowed in adults in combination with other medicinal products.

A pharmacovigilance plan for Viekirax is to be implemented as part of the approval.

The most common side effects are fatigue and nausea.

© arznei-news.de - Source: EMA, Nov. 2014

FDA approves Viekira Pak for the treatment of hepatitis C.

12/21/2014 The US Food and Drug Administration has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets [also under the name Viekirax] together with dasabuvir tablets) for the treatment of patients with chronic hepatitis C virus infection (HCV) of genotype 1, too with advanced liver disease (cirrhosis).

Viekira Pak contains three new medicines: ombitasvir, paritaprevir and dasabuvir, which, when combined, inhibit the growth of HCV. It also contains the previously approved drug ritonavir, which is said to be used to increase paritaprevir in the blood. Viekira Pak can be used with or without ribavirin, but it is not recommended in patients whose liver is no longer working properly (decompensated cirrhosis).

Viekira Pak's effectiveness was evaluated in six clinical studies involving 2,308 participants with chronic HCV infection with or without cirrhosis. In various studies, participants were randomized to receive Viekira Pak or a placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The most common side effects in the clinical trials reported by participants were fatigue, itching, weakness or lack of energy, nausea, and difficulty sleeping.
© arznei-news.de - Source: FDA, Dec. 2014

The CHMP recently recommended Viekirax for approval (see here).

EU approves Viekirax for HCV

01/16/2015 The European Commission has followed the recommendation of the CHMP and has approved AbbVie's orally administered, interferon-free drug Viekirax for hepatitis C.

Viekirax (active substances are: Ombitasvir / Paritaprevir / Ritonavir) has been approved in the USA under the name Viekira Pak + Exviera (Dasabuvir).

indication

The drug has been approved with or without ribavirin in patients with chronic HCV genotype 1 infection, including those with compensated cirrhosis, HIV-1 co-infection, patients on opioid replacement therapy and liver transplant recipients; in addition, Viekirax was approved with ribavirin in genotype 4 patients.

AbbVie Chief Executive Richard Gonzalez said the approval "offers patients across Europe a new and effective treatment to cure this serious disease". It will compete against Gileads Sciences Harvoni, who combines the bestseller Sovaldi (sofosbuvir) with the NS5A inhibitor ledipasvir in the treatment of HCV genotype 1 and 4 infection.

While these new drugs for hepatitis C are showing impressive effectiveness, there are concerns about the very high cost of these life-saving, highly innovative drugs, not least in Europe. Mr Gonzalez added that they will work with local governments and health systems to ensure widespread access to Viekira + Exviera.

The active ingredients of Viekirax are

  • Ombitasvir, an inhibitor of the HCV non-structural protein NS5A, which is essential for viral replication,
  • Paritaprevir, an inhibitor of the non-structural protein NS3 / 4A protease, which is also essential for viral replication and
  • Ritonavir, a potent cytochrome P450 3A4 inhibitor used to improve pharmacokinetics.

© arznei-news.de - Source: Abbvie, Jan. 2015

IQWiG: Indication of additional benefit in certain patients

05/04/2015 The Institute for Quality and Efficiency in Health Care (IQWiG) was able to find an indication of a non-quantifiable additional benefit of the active ingredient combination ombitasvir / paritaprevir / ritonavir (trade name Viekirax) in certain patient groups compared to the appropriate comparator treatment in its review of the study data made available Find.

An additional benefit (lasting virological response; quality of life) could be determined: in patients without liver cirrhosis and with an infection with the hepatitis C virus (HCV) of genotype 1a. If genotype 1b was present, only an additional benefit could be determined in patients who had not yet been treated. For other patient groups, no additional benefit could be derived from the information provided by the manufacturer, according to IQWiG.
© arznei-news.de - Source: Institute for Quality and Efficiency in Health Care (IQWiG), May 2015

Viekirax + Exviera show 100% cure rate for hepatitis C in phase III study

AbbVie has published clinical trial data from a Phase III study showing sustained response to oral, interferon-free Viekirax-based hepatitis C therapy.

According to the data from the TURQUOISE III study, genotype 1b HCV patients with compensated cirrhosis of the liver given Viekirax tablets (active ingredients are ombitasvir / paritaprevir / ritonavir) plus Exviera tablets (dasabuvir) showed a 100% sustained virological response 12 weeks after treatment.

The data shows, says Jordan Feld, director of research and clinical scientist at the Toronto Liver Disease Center in Toronto, Canada, that this patient subgroup has the potential to "achieve high response rates in 12 weeks of interferon- and ribavirin-free treatment" .

Viekirax + Exviera was approved in Europe in January (for genotypes 1 and 4) and as Viekira Pak in the US (for genotype 1) late last year. The cure competes with Gilead's Harvoni, which combines Sovaldi (Sofosbuvir), a nucleotide analogue polymerase inhibitor with the NS5A inhibitor ledipasvir against HCV genotype 1 and 4 infection.
© arznei-news.de - Source: AbbVie, June 2015

Rote-Hand-Brief - patients with liver dysfunction

04.01.2016 AbbVie and BfArM inform in a Rote-Hand-Brief about important new information about the safety of Viekirax with or without Exviera.

Thereafter, patients with severe hepatic impairment (Child-Pugh grade C) should no longer be treated with Viekirax (contraindicated) and treatment with this medicinal product is no longer recommended for persons with moderate hepatic impairment (Child-Pugh grade B).

The background to the Rote-Hand-Brief is that there were cases of “liver decompensation and liver failure, including liver transplantation and deaths”, who were treated simultaneously with Viekirax and Exviera (active substance dasabuvir), although most of these cases did previously already signs of advanced or decompensated Cirrhosis gave.

Therefore, people with cirrhosis should be monitored for liver decompensation and liver function tests should be performed in these patients before, during and possibly also after treatment.

In patients with moderate hepatic impairment receiving Viekirax with or without Exviera, a risk-benefit assessment should be made.

See a doctor immediately if there are early signs of liver inflammation, liver failure, or liver decompensation.
© arznei-news.de - Source: BfArM, Jan. 2016

Genotype 1b: 8 week treatment option; CHMP recommendation

02/27/2017 AbbVie has announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved the shorter, eight-week treatment of Viekirax (ombitasvir / paritaprevir / ritonavir tablets) + Exviera (dasabuvir tablets) as an option Recommended for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and minimal to moderate fibrosis.

The combination VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment in GT1b chronically HCV-infected patients without cirrhosis or with compensated cirrhosis.

The recommendation is based on data from the dedicated phase 3b study GARNET. The results showed that after eight weeks of treatment with the combination, 98 percent (n = 160/163) of the previously untreated GT1b-chronically HCV-infected patients without cirrhosis achieved a sustained virological response at SVR12 (post-treatment 12 weeks).

The most common side effects (5% or more) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent), and asthenia (5 percent).
© arznei-news.de - Source: AbbVie, Feb. 2017

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This information is NOT intended to be used as a recommendation for any particular drug. Even if these reports, studies, experiences can be helpful, they are no substitute for the experience and expertise of doctors.

Categories anti-infectives