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Epclusa News

Doctors Seeing More HIV Patients With Multidrug Resistance

Posted 2 days 2 hours 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, Viread, Viekira Pak, Kaletra, Entecavir, Tenofovir

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, Viekira Pak, Epclusa, Daklinza, Ledipasvir/sofosbuvir, Olysio, Simeprevir, Viekira XR, Daclatasvir, Technivie, Ombitasvir/paritaprevir/ritonavir, Sofosbuvir/velpatasvir, Elbasvir/grazoprevir, Dasabuvir/ombitasvir/paritaprevir/ritonavir

Epclusa Approved for Chronic Hepatitis C

Posted 29 Jun 2016 by Drugs.com

TUESDAY, June 28, 2016 – The combination drug Epclusa has been approved by the U.S. Food and Drug Administration to treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved in 2013, and the new drug velpatasvir. For people with moderate-to-severe cirrhosis (chronic liver disease), Epclusa is approved to be used in combination with the drug ribavirin. Epclusa also is approved for use in people who haven't developed cirrhosis, the agency said Tuesday in a news release. HCV causes liver inflammation and diminished liver function. Some 75 percent of Americans with the disease have genotype 1, although there are five other strains. The disease typically becomes chronic, leading to possible complications including bleeding, yellowing of the skin and eyes (jaundice), abdominal fluid accumulation and liver cancer. It could lead to death. Epclusa ... Read more

Related support groups: Hepatitis C, Sofosbuvir, Epclusa, Sofosbuvir/velpatasvir

FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection

Posted 28 Jun 2016 by Drugs.com

June 28, 2016 – The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV. “This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six ... Read more

Related support groups: Hepatitis C, Sovaldi, Sofosbuvir, Epclusa, Sofosbuvir/velpatasvir

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