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FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV

Posted 9 Aug 2017 by

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 1, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include ...

FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus

Posted 18 Jul 2017 by

July 18, 2017 – The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients w ...

Experimental Drug Shows Promise Against Dangerous Viruses

Posted 29 Jun 2017 by

THURSDAY, June 29, 2017 – An experimental antiviral drug is effective against a number of coronaviruses, including some that can cause deadly epidemics, researchers say. Coronaviruses are a large family of viruses that infect birds and mammals, including humans. These viruses include severe acute respiratory syndrome (SARS), which has a 10 percent death rate, and Middle East respiratory syndrome ...

New Combo Pill Offers Hope to Hepatitis C Patients Who Fail Other Treatment

Posted 1 Jun 2017 by

WEDNESDAY, May 31, 2017 – A pill that contains three powerful antiviral drugs might offer a cure for many hepatitis C patients who have failed other treatments, researchers report. The pill – which contains the antiviral drugs sofosbuvir (Sovaldi), velpatasvir and voxilaprevir – was nearly 100 percent effective in curing hepatitis C in patients whose disease returned after treatment with other ...

New Hepatitis C Treatments More Effective, Tolerable: FDA

Posted 11 May 2017 by

THURSDAY, May 11, 2017 – Hepatitis C can be cured in about three months, allowing people with the viral disease to live longer, healthier lives, the U.S. Food and Drug Administration (FDA) says. Drugs used to clear the virus from the body are not only more effective than they once were but also more tolerable for patients, according to Dr. Jeffrey Murray, an internist at the FDA who specializes ...

FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

Posted 8 Apr 2017 by

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indications for Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or ...

FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients

Posted 7 Apr 2017 by

April 7, 2017 – The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. ...

FDA Approves Hep C Drugs for Kids 12 and Older

Posted 7 Apr 2017 by

FRIDAY, April 7, 2017 – The U.S. Food and Drug Administration has approved two drugs to treat hepatitis C infection in children aged 12 and older. Both Solvaldi (sofosbuvir) and Harvoni (ledipasvir, sofosbuvir) are already approved for use in adults, the agency said in a news release Friday. The medications are antivirals that prevent the hepatitis C virus (HCV) from reproducing. "In most cases, ...

New Hepatitis C Drugs Might Eliminate the Disease

Posted 20 Mar 2017 by

MONDAY, March 20, 2017 – Newer treatments for hepatitis C appear to eliminate the virus in the vast majority of those taking oral antiviral medications, raising the hope that this disease might someday be eradicated in the United States. The oral medications "work really well in most patients that have hepatitis C," said Dr. Oluwaseun Falade-Nwulia, the study's lead author. She's an assistant ...

Newer Hepatitis C Drugs May Pose Health Risks: Study

Posted 25 Jan 2017 by

Newer drugs to cure hepatitis C may put patients at risk for liver failure and other severe side effects, according to a new study from a U.S. nonprofit group that examines drug safety. The study by the Institute for Safe Medication Practices is based on an analysis of U.S. Food and Drug Administration data and reports from doctors worldwide on adverse events possibly caused by the nine widely ...

Doctors Seeing More HIV Patients With Multidrug Resistance

Posted 1 Dec 2016 by

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 ...

HIV May Hide in Tissues, Even After Treatment

Posted 27 Oct 2016 by

WEDNESDAY, Oct. 26, 2016 – HIV patients who've been treated with antiretroviral drugs still have the AIDS-causing virus in their tissues, a new study suggests. Treatment with antiretrovirals eliminates detectable levels of HIV in the blood and controls the disease. But the new findings suggest that HIV in the tissues may not cause AIDS but could contribute to the development of unrelated ...

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

Posted 10 Oct 2016 by

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 ...

Epclusa Approved for Chronic Hepatitis C

Posted 29 Jun 2016 by

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 ...

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

Posted 28 Jun 2016 by

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, ...

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