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Ledipasvir / sofosbuvir News

Doctors Seeing More HIV Patients With Multidrug Resistance

Posted 1 day ago 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, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Sofosbuvir, Zepatier, Viread, Viekira Pak, Kaletra, Entecavir, Tenofovir

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, Viekira Pak, Epclusa, 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, Viread, Zepatier, Kaletra, Viekira Pak, Norvir, Daklinza

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, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Viread, Zepatier, Kaletra, Viekira Pak, Norvir, Entecavir, Tenofovir, Telaprevir

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, Interferon Alfa-2B/Ribavirin, Rebetol, Ledipasvir/sofosbuvir, Rebetron, RibaPak, Hepatic Tumor, Daclatasvir, Virazole, 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, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Viread, Kaletra, Viekira Pak, Norvir, Entecavir, Tenofovir, Telaprevir, Lamivudine

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, Viral Infection, Victrelis, Genvoya, Viread, Viekira Pak, Kaletra, Tenofovir, Norvir, Entecavir, Telaprevir

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, Complera, Triumeq, Baraclude, Victrelis, Genvoya, Viread, Oseltamivir, Kaletra, Viekira Pak, Norvir, Entecavir, Tenofovir

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, Viekira Pak, Kaletra, 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

Risky Sexual Behaviors Put Many Young Gay Men at Risk of HIV: Study

Posted 7 Dec 2015 by Drugs.com

MONDAY, Dec. 7, 2015 – Young American gay and bisexual men who have detectable blood levels of HIV – the virus that causes AIDS – are also more likely to engage in risky sexual behavior that might spread the virus, a new study has found. "While many of these young men are engaged in care, and success stories are many, we still have work to do to reduce the rate of new infections," study author Patrick Wilson, an assistant professor of sociomedical sciences at Columbia University's Mailman School of Public Health in New York City, said in a university news release. Different strategies to help prevent HIV infections and promote safe sex are needed for this group, his team wrote in the Dec. 7 issue of the journal JAMA Pediatrics. According to the researchers, young men between the ages of 13 and 29 who are gay or bisexual are particularly vulnerable to infection with HIV and now ... Read more

Related support groups: Birth Control, Contraception, Emergency Contraception, Harvoni, HIV Infection, Postcoital Contraception, Atripla, Pre-Exposure Prophylaxis, Incivek, Truvada, Stribild, Complera, Triumeq, Baraclude, Victrelis, Viread, Kaletra, Viekira Pak, Norvir, Entecavir

HIV Rates Fall, But Not All Groups Benefit, U.S. Study Finds

Posted 7 Dec 2015 by Drugs.com

MONDAY, Dec. 7, 2015 – The number of Americans diagnosed with HIV each year declined by about one-fifth during the past decade, but not all groups saw drops in prevalence, a federal government study shows. Between 2005 and 2014, the overall annual number of HIV diagnoses fell 19 percent – from nearly 48,800 to just over 39,700 a year. The drop was led by a 63 percent decline among injection drug users, a 42 percent drop among black women, and a 35 percent decrease among heterosexuals. However, annual HIV diagnoses among gay and bisexual men actually rose about 6 percent during the study period, from about 25,000 to just over 26,600 a year, although they recently stabilized at less than a 1 percent increase a year. The increase in HIV diagnoses among gay and bisexual men was driven largely by blacks and Hispanics, the U.S. Centers for Disease Control and Prevention report found. HIV ... Read more

Related support groups: Harvoni, HIV Infection, Atripla, Incivek, Truvada, Stribild, Triumeq, Complera, Baraclude, Victrelis, Viread, Kaletra, Viekira Pak, Norvir, Tenofovir, Entecavir, Telaprevir, Diagnosis and Investigation, Combivir, Prezista

FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV

Posted 12 Nov 2015 by Drugs.com

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 12, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. “Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been consi ... Read more

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

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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