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

Posted 8 Apr 2017 by Drugs.com

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 asupplemental indication for Harvoni (ledipasvir 90 mg/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 weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth. Harvoni has a boxed warning in its product label regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients. See below for important safety information. Harvoni for Pediatric Patients The supplemental new drug ... Read more

Related support groups: Hepatitis C, Harvoni, Ledipasvir/sofosbuvir

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

Posted 7 Apr 2017 by Drugs.com

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. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV. “These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Today’s approvals provide pediatric treatment options for six major genotypes, or strains, of HCV. Harvoni is in ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Sofosbuvir, Ledipasvir/sofosbuvir

FDA Approves Hep C Drugs for Kids 12 and Older

Posted 7 Apr 2017 by Drugs.com

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, they cure HCV," the FDA added. "These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. Hepatitis C causes liver inflammation that can lead to liver failure. Between 3 and 4 million people in the United States are infected with the virus, the agency said. Children born to infected mothers are at higher risk ... Read more

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

New Hepatitis C Drugs Might Eliminate the Disease

Posted 20 Mar 2017 by Drugs.com

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 professor of medicine at Johns Hopkins University School of Medicine in Baltimore. Most people have a 95 percent chance of being cured, meaning the hepatitis C virus is no longer detectable in a person's bloodstream, the finding showed. "The other big message is that these therapies are very safe. The risk of side effects are very low," she said. Plus, many patients can be treated in just 12 weeks, according to the study published online March 20 in the Annals of Internal Medicine. "It's ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Ribavirin, Epclusa, Sofosbuvir, Copegus, Ribasphere, Ledipasvir/sofosbuvir, Interferon Alfa-2A, Rebetol, Interferon Alfa-2B/Ribavirin, RibaPak, Olysio, Rebetron, Virazole, Roferon-A, Moderiba, Sofosbuvir/velpatasvir, RibaTab

Newer Hepatitis C Drugs May Pose Health Risks: Study

Posted 25 Jan 2017 by Drugs.com

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 used antiviral drugs, The New York Times reported. Two of the drugs, Sovaldi and Harvoni, are so-called blockbusters made by Gilead Sciences and priced at $1,000 a pill. Sovaldi was approved in 2013 and Harvoni in 2014. These and other antiviral drugs can cure hepatitis C in 12 weeks in many patients. The number of adverse events is fairly small and the findings are not conclusive, but experts say the study published online Wednesday should serve as a warning, The Times reported. The study said ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Ribavirin, Incivek, Epclusa, Victrelis, Sofosbuvir, Liver and Pancreatic Disease, Copegus, Ribasphere, Telaprevir, Boceprevir, Interferon Alfa-2B/Ribavirin, Rebetol, Ledipasvir/sofosbuvir, RibaPak, Olysio, Rebetron, Simeprevir

Doctors Seeing More HIV Patients With Multidrug Resistance

Posted 1 Dec 2016 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, Triumeq, Complera, Epclusa, Zepatier, Baraclude, Genvoya, Victrelis, Sofosbuvir, Viread, Kaletra, Viekira Pak, Norvir

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

HIV Infection Seems to Affect Nervous System

Posted 13 Jun 2016 by Drugs.com

MONDAY, June 13, 2016 – Many newly infected HIV patients experience neurological problems, but they tend to be mild and they subside after antiretroviral drugs are given, a new study finds. "We were surprised that neurologic findings were so pervasive in participants diagnosed with very recent HIV infection," said study author Dr. Joanna Hellmuth. She is a clinical fellow in the department of neurology at the University of California, San Francisco (UCSF). "While the findings were mild, it is clear that HIV affects the nervous system within days of infection," she said in a university news release. "Since the majority of these neurologic issues were resolved with treatment, our study reinforces recommendations that people at risk for HIV test often and start antiretroviral treatment immediately if they are infected," Hellmuth added. Among 139 people in Thailand infected with HIV three ... Read more

Related support groups: Peripheral Neuropathy, Harvoni, HIV Infection, Atripla, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Triumeq, Complera, Autonomic Neuropathy, Zepatier, Genvoya, Baraclude, Victrelis, Viread, Kaletra, Viekira Pak, Daklinza, Entecavir

HIV Decline Falls Short of U.S. 5-Year Goal

Posted 6 May 2016 by Drugs.com

FRIDAY, May 6, 2016 – Although HIV infection and transmission rates in the United States declined over the past five years, they fell short of White House targets, a new study finds. Between 2010 and 2015, new HIV infections decreased 11 percent and transmission of the AIDS-causing virus declined 17 percent, far less than the goals set in 2010 as part of the U.S. National HIV/AIDS Strategy (NHAS), researchers said. The NHAS goals for 2015 were reductions of 25 percent for new HIV infections and 30 percent declines in HIV transmission. "Even though we missed the goals by a sizable margin, it's promising to see that we made important progress in reducing rates of HIV infection and transmission," said lead study author Robert Bonacci. He is a fourth-year medical student at the University of Pennsylvania Perelman School of Medicine. The aim was to lower the persistent HIV infection rate ... Read more

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

Generic Hepatitis C Drugs as Effective as Pricey Brand Names: Study

Posted 18 Apr 2016 by Drugs.com

SATURDAY, April 16, 2016 – Low-cost generic antiviral drugs are as effective and safe as more expensive brand-name drugs in treating people with hepatitis C, researchers report. In many countries, people don't have access to a course of brand-name direct-acting antiviral drugs due to the high cost – as much as $94,000 a patient, the researchers explained. However, mass-produced generic versions are available for less than 1 percent of the retail price of the brand-name drugs, they added. "Our interim data suggests a potential solution for hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said study author Dr. James Freeman, of GP2U Telehealth in Hobart, Australia. The study of patients in the United States, Canada, Africa, Australia, Europe and Southeast Asia found that generic direct-acting ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Ribavirin, Sofosbuvir, Liver and Pancreatic Disease, Daklinza, Copegus, Ribasphere, Rebetol, Ledipasvir/sofosbuvir, Interferon Alfa-2B/Ribavirin, RibaPak, Daclatasvir, Rebetron, Virazole, Hepatic Tumor, Moderiba, RibaTab

Prenatal Use of HIV Drug May Slow Child's Development Slightly

Posted 23 Feb 2016 by Drugs.com

TUESDAY, Feb. 23, 2016 – A drug used to prevent mother-to-child HIV transmission during pregnancy may slow language development slightly in children, a new study suggests. Researchers followed more than 900 infants who were born to HIV-positive mothers but were not infected by the AIDS-causing virus. All of the mothers took antiretroviral drugs during pregnancy. Some of the treatment regimens included a drug called atazanavir (Reyataz), while others did not. The infants underwent a standard test of development at 1 year of age. The 167 infants whose mothers took atazanavir during pregnancy had slightly lower language and social development scores than the 750 infants whose mothers did not take the drug. But the study only showed an association between atazanavir and language delays in children, and did not prove a cause-and-effect link. And the difference in social development scores ... Read more

Related support groups: Harvoni, HIV Infection, Atripla, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Triumeq, Complera, Baraclude, Genvoya, Victrelis, Viread, Viekira Pak, Kaletra, Tenofovir, Norvir, Entecavir, Lamivudine, Telaprevir

Vaginal Ring Offers Some Protection Against HIV, Study Says

Posted 23 Feb 2016 by Drugs.com

MONDAY, Feb. 22, 2016 – An insertable vaginal ring containing a month's supply of a continuous-release HIV prevention drug reduced the risk of HIV in African women by at least 27 percent, a new study found. The ring works by slowly and continuously delivering a highly localized and controlled amount of the antiretroviral medication dapivirine. This drug aims to halt the ability of HIV – the virus that causes AIDS – to replicate inside a healthy cell. The goal: to prevent HIV infection, rather than treat it, the researchers said. "These results come after a number of challenging years in the effort to find ways to improve HIV control," said study lead author Dr. Jared Baeten, a professor in the departments of global health, medicine and epidemiology at the University of Washington in Seattle. "But while the dapivirine vaginal ring isn't commercially available yet, I'm really very ... Read more

Related support groups: Harvoni, HIV Infection, Atripla, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Triumeq, Complera, Baraclude, Genvoya, Viral Infection, Victrelis, Viread, Kaletra, Viekira Pak, Tenofovir, Norvir, Entecavir, Lamivudine

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

Posted 18 Feb 2016 by Drugs.com

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 16, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients ... Read more

Related support groups: Hepatitis C, Harvoni, Ledipasvir/sofosbuvir

CDC: Black Americans With HIV Still Less Likely to Get Ongoing Medical Care

Posted 5 Feb 2016 by Drugs.com

FRIDAY, Feb. 5, 2016 – While HIV diagnoses dropped significantly over the past decade in the United States, blacks with HIV are less likely than whites or Hispanics to receive routine, ongoing care, according to the U.S. Centers for Disease Control and Prevention. From 2005 to 2014, annual HIV diagnoses fell 19 percent in the United States. Infections among black women dropped 42 percent during this period. Despite this progress in the fight against HIV, racial disparities persist, the CDC found. While black people make up 12 percent of the U.S. population, they accounted for nearly half of all HIV diagnoses in 2014. "CDC has been working for many years to eliminate the HIV disparities that exist within the black community," Dr. Eugene McCray, director of the CDC's Division of HIV/AIDS Prevention, said in an agency news release. "While we are seeing signs of success, we must continue ... Read more

Related support groups: Harvoni, HIV Infection, Tamiflu, Atripla, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Triumeq, Complera, Genvoya, Baraclude, Victrelis, Oseltamivir, Viread, Kaletra, Viekira Pak, Entecavir, Tenofovir, Norvir

HIV Can Persist in Body Despite Drug Therapy

Posted 27 Jan 2016 by Drugs.com

WEDNESDAY, Jan. 27, 2016 – Even when blood tests of HIV patients on antiretroviral drugs show no sign of the AIDS-causing virus, it can still be replicating in lymphoid tissue, researchers report. The study offers important new insight into how HIV persists in the body despite treatment with the powerful drugs, according to the team of international researchers led by Northwestern University's Feinberg School of Medicine in Chicago. To reach their finding, they examined viral sequences in samples of lymph node and blood cells from three HIV-infected patients who had no detectable virus in their blood. And what they found was that a viral reservoir in lymphoid tissue, which scientists believed held long-lived infected cells in a resting state, was being constantly replenished with infected cells. "The challenge is to deliver drugs at clinically effective concentrations to where the ... Read more

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

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