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Harvoni News

Could a Monetary Perk Help Keep HIV Patients on Their Meds?

Posted 22 Jun 2017 by Drugs.com

WEDNESDAY, June 21, 2017 – There are mixed results from a new study on the use of monetary rewards to help boost the odds that HIV-infected patients will enter care, and take their meds as directed. The study, conducted at HIV clinics in New York City and Washington, D.C., found that financial incentives such as gift cards could improve the likelihood that HIV patients would take antiretroviral medications that suppress the AIDS-causing virus. But the effect was modest in patients already receiving care, and the gift cards had little effect on increasing the number of new HIV-positive patients who got treated, the study authors said. Still, lead author Dr. Wafaa El-Sadr called the results "encouraging" and said they "should motivate efforts to pursue the further assessment of using financial incentives in HIV treatment programs and to determine their potential impact when scaled up." ... Read more

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

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

Americans With HIV Staying on Lifesaving Meds Longer

Posted 31 May 2017 by Drugs.com

WEDNESDAY, May 31, 2017 – More Americans with HIV are sticking with medications that turn a fatal disease into a manageable condition, a new study shows. "This represents a lot of people who are not dying and not infecting others," said study corresponding author Ira Wilson, chair of Brown University's Health Services Policy and Practice Department, in Providence, R.I. "These differences represent tremendous, very real benefit," he added in a university news release. While there have been significant increases in how long HIV patients take their medications, many people still stop taking the drugs after a few years, the researchers cautioned. In the study, the researchers analyzed data from nearly 43,600 Medicaid patients in 14 states from 2001 to 2010, and found the length of time patients kept taking antiretroviral medications increased more than 50 percent. In 2001-2003, half of ... Read more

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

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 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, Sofosbuvir/velpatasvir, Roferon-A, Virazole, Moderiba, 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, Sofosbuvir, Victrelis, Liver and Pancreatic Disease, Copegus, Ribasphere, Telaprevir, Boceprevir, Interferon Alfa-2B/Ribavirin, Rebetol, Ledipasvir/sofosbuvir, RibaPak, Olysio, Rebetron, Sofosbuvir/velpatasvir

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, Pre-Exposure Prophylaxis, Sovaldi, Incivek, Epclusa, Truvada, Triumeq, Stribild, Zepatier, Complera, Genvoya, Baraclude, Victrelis, Sofosbuvir, Viread, Tenofovir, Kaletra, Viekira Pak

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, Sofosbuvir/velpatasvir, Daclatasvir, Ombitasvir/paritaprevir/ritonavir, Simeprevir, Viekira XR, Technivie, 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, Triumeq, Stribild, Zepatier, Complera, Autonomic Neuropathy, Genvoya, Baraclude, Victrelis, Tenofovir, Viread, Daklinza, Kaletra, Viekira Pak

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, Triumeq, Stribild, Zepatier, Complera, Genvoya, Baraclude, Victrelis, Tenofovir, Viread, Viekira Pak, Kaletra, 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, Daklinza, Liver and Pancreatic Disease, 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, Triumeq, Stribild, Complera, Genvoya, Baraclude, Victrelis, Tenofovir, Viread, Viekira Pak, Kaletra, Norvir, Entecavir, Lamivudine, Telaprevir

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