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Daklinza News

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, Simeprevir, Viekira XR, Daclatasvir, Technivie, Ombitasvir/paritaprevir/ritonavir, Sofosbuvir/velpatasvir, Elbasvir/grazoprevir, Dasabuvir/ombitasvir/paritaprevir/ritonavir

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, Complera, Triumeq, Autonomic Neuropathy, Baraclude, Victrelis, Genvoya, Zepatier, Viread, Kaletra, Viekira Pak, Norvir, Daklinza

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, Copegus, Ribasphere, Daklinza, Ledipasvir/sofosbuvir, Interferon Alfa-2B/Ribavirin, Rebetol, Rebetron, RibaPak, Daclatasvir, Virazole, Hepatic Tumor, Moderiba, RibaTab

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

Posted 24 Feb 2016 by Drugs.com

PRINCETON, N.J., February 5, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ... Read more

Related support groups: Hepatitis C, Daklinza, Daclatasvir

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, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Sofosbuvir, Viread, Kaletra, Viekira Pak, Norvir, Daklinza, Entecavir

FDA Lifts Ban on Blood Donations by Gay Men

Posted 21 Dec 2015 by Drugs.com

MONDAY, Dec. 21, 2015 – Gay and bisexual men who have abstained from sex for one year will now be allowed to donate blood in the United States. The new policy, announced Monday by the U.S. Food and Drug Administration, reverses a three-decades-old ban on donations from this group of men that traces back to the start of the AIDS epidemic. "The FDA's responsibility is to maintain a high level of blood product safety for people whose lives depend on it," FDA Acting Commissioner Stephen Ostroff said in an agency news release. "We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply." The FDA said it was changing its policy based on data from other countries that show allowing such donations would not increase the risk of HIV-tainted blood entering America's blood supply. FDA officials have estimated that about half of the ... Read more

Related support groups: Blood Disorders, Bleeding Disorder, Harvoni, HIV Infection, Valtrex, Anemia, Acyclovir, Tamiflu, Atripla, Valacyclovir, Ribavirin, Pre-Exposure Prophylaxis, Incivek, Blood Transfusion, Zovirax, Truvada, Stribild, Triumeq, Complera, Baraclude

FDA Approves Daklinza (daclatasvir) for Chronic Hepatitis C Genotype 3 Infections

Posted 27 Jul 2015 by Drugs.com

July 24, 2015 – The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, ... Read more

Related support groups: Hepatitis C, Sofosbuvir, Daklinza, Daclatasvir

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