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Viekira XR News

Doctors Seeing More HIV Patients With Multidrug Resistance

Posted 6 days ago by Drugs.com

THURSDAY, Dec. 1, 2016 – A significant number of people with HIV have strains of the AIDS-causing virus that are resistant to both older and newer drugs, researchers report. The researchers looked at 712 HIV patients worldwide whose infection was not controlled by antiretroviral drugs. They found that 16 percent of patients whose infection was resistant to modern drugs had HIV mutations linked with resistance to older drugs called thymidine analogues. Among patients whose HIV had this mutation, 80 percent were also resistant to tenofovir, the main drug in most modern HIV treatment and prevention programs, the researchers reported. The findings were published in the Nov. 30 issue of The Lancet Infectious Diseases journal. "We were very surprised to see that so many people were resistant to both drugs, as we didn't think this was possible," study lead author Ravi Gupta, of University ... Read more

Related support groups: Harvoni, HIV Infection, Atripla, Sovaldi, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Sofosbuvir, Zepatier, Epclusa, Viread, Viekira Pak, Kaletra, Entecavir

FDA Medwatch Alert: Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

Posted 10 Oct 2016 by Drugs.com

ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines. BACKGROUND: Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) ... Read more

Related support groups: Hepatitis C, Harvoni, Hepatitis B, Sovaldi, Sofosbuvir, Zepatier, Epclusa, Viekira Pak, Daklinza, Ledipasvir/sofosbuvir, Olysio, Viekira XR, Simeprevir, Daclatasvir, Technivie, Ombitasvir/paritaprevir/ritonavir, Sofosbuvir/velpatasvir, Elbasvir/grazoprevir, Dasabuvir/ombitasvir/paritaprevir/ritonavir

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

Posted 28 Jul 2016 by Drugs.com

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ – 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. 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. ... Read more

Related support groups: Hepatitis C, Hepatitis, Viekira Pak, Viekira XR, Dasabuvir/ombitasvir/paritaprevir/ritonavir

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