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

Posted 1 Jun 2017 by Drugs.com

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 antiviral drugs, the researchers said. "Currently, we have very good treatments for hepatitis C, and we are able to achieve a cure in over 90 percent of patients. So globally, although only a few patients relapse, it still is a significant number," said lead researcher Dr. Marc Bourliere, from the Hospital Saint Joseph in Marseilles, France. This new pill is being developed as a rescue treatment for patients who have failed other therapy, he said. When it was used as an initial treatment in ... Read more

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

New Hepatitis C Treatments More Effective, Tolerable: FDA

Posted 11 May 2017 by Drugs.com

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 in infectious diseases. Hepatitis is inflammation of the liver that is caused by different viruses. In the United States, hepatitis C is the most common chronic bloodborne infection. Avoiding risky behaviors, such as sharing drug needles, can help prevent the spread of the disease, but there is no vaccine for hepatitis C. Hepatitis is often a silent disease. Many people are unaware they are infected for years and learn about their infection only after they have developed serious liver disease or ... Read more

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

FDA Approves Sovaldi (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 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 weighing at least 35kg. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. 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. Sovaldi has a boxed warning in their respective product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients. See below for important safety information. Sovaldi for Pediatric Patients The ... Read more

Related support groups: Hepatitis C, Sovaldi, 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, Rebetol, Interferon Alfa-2A, Interferon Alfa-2B/Ribavirin, RibaPak, Olysio, Rebetron, Roferon-A, Virazole, 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, Rebetol, Ledipasvir/sofosbuvir, Boceprevir, Interferon Alfa-2B/Ribavirin, 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, Epclusa, Stribild, Triumeq, Complera, Zepatier, Baraclude, Genvoya, Victrelis, Sofosbuvir, Viread, Kaletra, Viekira Pak, Norvir

HIV May Hide in Tissues, Even After Treatment

Posted 27 Oct 2016 by Drugs.com

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 conditions, such as cancer and heart disease, according to the University of California, San Francisco (UCSF) researchers. "Looking in tissues of treated HIV patients, we found that HIV in some tissues did not appear to be affected by antiretrovirals," said study senior author Dr. Michael McGrath. "Notably we saw no evidence of drug resistance, which we would have seen if the virus had been exposed to medications," said McGrath. He is UCSF professor of laboratory medicine at the AIDS and Cancer ... Read more

Related support groups: HIV Infection, Valtrex, Acyclovir, Sovaldi, Valacyclovir, Pre-Exposure Prophylaxis, Ribavirin, Incivek, Zovirax, Baraclude, Famciclovir, Victrelis, Sofosbuvir, Famvir, Viread, Kaletra, Valcyte, Ganciclovir, Copegus, 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, Daklinza, Viekira Pak, Ledipasvir/sofosbuvir, Olysio, Daclatasvir, Ombitasvir/paritaprevir/ritonavir, Simeprevir, Viekira XR, Technivie, Elbasvir/grazoprevir, Dasabuvir/ombitasvir/paritaprevir/ritonavir, 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, Epclusa, Sofosbuvir, Sofosbuvir/velpatasvir

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

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, Viekira Pak, Kaletra, Daklinza, Entecavir, Tenofovir

Pricey Hepatitis C Drugs Denied to Almost Half of Medicaid Patients: Study

Posted 24 Nov 2015 by Drugs.com

TUESDAY, Nov. 24, 2015 – Nearly half of Medicaid patients with chronic hepatitis C have been denied cutting-edge medications that would most likely cure their condition, due to tight controls that states have placed on coverage of the pricey drugs, a new study shows. About 46 percent of Medicaid patients in four northeastern states were denied treatment with new direct-acting antiviral (DAA) drugs, which have been shown to cure more than nine out of 10 hepatitis C patients, the researchers reported. These powerful medications include Sovaldi (sofosbuvir) and Harvoni (ledipasvir). By comparison, only 10 percent of privately insured patients and 5 percent of Medicare patients were denied treatment, said study author Dr. Vincent Lo Re III, an assistant professor of medicine and epidemiology in the division of infectious diseases at the Perelman School of Medicine at the University of ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi

In Rare Cases, Hepatitis C Drug Tied to Slowed Heart Rate: Study

Posted 4 Nov 2015 by Drugs.com

WEDNESDAY, Nov. 4, 2015 – One of the new, highly effective drugs for treating hepatitis C can cause a very slow and erratic heart rate in some patients, new research warns. Doctors at a Paris hospital found that three out of 415 chronic hepatitis C patients treated with the drug sofosbuvir during 2014 developed an abnormally slow heart rate, called an bradyarrhythmia. In all three cases, the patients were also receiving other hepatitis C medications, including daclatasvir, simeprevir and ribavirin, according to the report. "The potential cardiac toxicity of sofosbuvir-containing regimens suggests the need for caution with the use of such regimens," the Parisian doctors concluded in the report. They suggested that doctors review other medications and potential risk factors for an abnormal heart rate before prescribing the drug. And, they pointed out the possible need to monitor the ... Read more

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

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