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FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir) to Include 240-Week Results from STARTMRK Study of ISENTRESS Containing Regimen in Previously Untreated HIV-1 Infected Adult Patients

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination HIV therapy.  READ MORE...


WHO Issues New HIV Recommendations Calling For Earlier Treatment

New HIV treatment guidelines by WHO recommend offering antiretroviral therapy (ART) earlier. Recent evidence indicates that earlier ART will help people with HIV to live longer, healthier lives, and substantially reduce the risk of transmitting HIV to others. The move could avert an additional 3 million deaths and prevent 3.5 million more new HIV infections between now and 2025. READ MORE... 

 

Treatment as Prevention in the Real World

A Chinese study proves that antiretroviral therapy can indeed reduce transmissions among serodiscordant heterosexual couples—but the results also underscore noteworthy limitations. With the August 2011 publication of a groundbreaking study that showed antiretroviral (ARV) treatment could reduce infection rates among heterosexual serodiscordant couples by 96 percent, the gathering treatment-as-prevention movement received a major jolt. READ MORE...


FACT SHEET: Accelerating Improvements in HIV Prevention and Care in the United States through the HIV Care Continuum Initiative

In July 2010, President Obama released the first comprehensive National HIV/AIDS Strategy. The HIV Care Continuum Initiative calls for coordinated action in response to data that has been released since the Strategy three years ago, showing only a quarter of people living with HIV in the United States have achieved the treatment goal of controlling the HIV virus. READ MORE... 

 

Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. READ MORE...

 

Gilead Sciences gets US FDA approval for Stribild, a complete once-daily single tablet regimen to treat naïve adults with HIV-1 infection

Aug. 29 The US Food and Drug Administration (FDA) has approved Gilead Sciences' Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate. READ MORE...


U.S. Issues New Guidelines for HIV, Gonorrhea Prevention

Doctors can give the HIV medicine Truvada as a preventative to healthy heterosexuals at high risk of the virus and should treat gonorrhea differently to hold off a drug-resistant form growing outside the country, U.S. officials said. The CDC in January 2011 advised that Gilead Sciences Inc. (GILD)’s once-a-day pill Truvada was safe and partially effective as a preventative for homosexual men, and suggested frequent testing if the medicine was used. The gonorrhea guideline issued today urges doctors to use more potent antibiotic injections instead of cefixime, the pill that has been the standard of care. READ MORE...


Combining Pap Smears With HPV Testing May Reduce Cervical Cancer Screenings for Women With HIV

Combining standard Pap smears with testing for human papillomavirus (HPV) may allow women living with HIV to reduce the frequency of cervical cancer screenings and unnecessary biopsies, according to a new study published in the July 25 issue of the Journal of the American Medical Association (JAMA). READ MORE...


U.S. health panel likely to make HIV tests routine

A U.S. health panel may soon make HIV testing as standard a practice as checking cholesterol levels, a move that would fundamentally change how the virus is detected and treated. The U.S. Preventive Services Task force, a government-backed group of clinicians and scientists, is expected to make a new recommendation on HIV screening available for public comment before the end of the year. Health officials close to the panel, speaking on condition of anonymity, see it making a positive recommendation for routine screening, updating their current position, issued in 2005, which leaves the decision up to doctors. READ MORE...


Hope for patients with HIV-associated cognitive impairment: Researchers discover compounds in green tea and chocolate may help reduce neurological complications linked to HIV

Current drug therapy for patients with HIV is unable to control the complete replication of the virus in the brain. The drugs therefore do not have any effect against the complications associated with neurocognitive impairment in patients with HIV. New research by Joseph Steiner and colleagues from Johns Hopkins University has discovered that a group of plant polyphenols known as catechins, which naturally occur in green tea and the seed of the cacao tree, may help in the prevention of these neurological complications. Their work is published online in Springer's Journal of NeuroVirology. READ MORE...


Among New HIV Treatment Recommendations, All Adult Patients Should Be Offered Antiretroviral Therapy

Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS. Other new recommendations include changes in therapeutic options and modifications in the timing and choice of ART for patients with an opportunistic illness such as tuberculosis. READ MORE....


Dolutegravir Matches Raltegravir for People Starting HIV Treatment
The novel integrase inhibitor dolutegravir worked as well as raltegravir (Isentress) at 48 weeks for treatment-naive people in the Phase 3 SPRING-2 study, according to a late-breaker presentation at the 19th International AIDS Conference (AIDS) this week in Washington, DC. HIV integrase inhibitors prevent the virus from inserting its genetic material into host cells. The sole approved drug in this class, twice-daily raltegravir, has demonstrated long-term efficacy with low toxicity and few drug interactions, though it has a relatively low barrier to resistance. READ MORE...


Benefits of HIV drugs rise -- but less than previously believed, Penn study shows
The percentage of HIV patients taking antiretroviral drugs who experienced the full benefit of the drugs jumped from 45 percent of 72 percent during the past decade, a figure that is lower than previous estimates. The findings, considered important for HIV prevention efforts, since patients whose virus is in tight control are less likely to transmit the infection to others, are published this week in JAMA by a team of researchers led by the Perelman School of Medicine at the University of Pennsylvania and Johns Hopkins University School of Medicine. The issue's publication coincides with AIDS 2012, the annual international AIDS conference, being held in the United States for the first in over 20 years this week in Washington, D.C. READ MORE....


Low-Dose Aspirin Helps Reduce Cardiovascular Risk Associated With HIV Therapy

Low-dose aspirin shows efficacy in attenuating platelet activation among adults with HIV, according to a study presented here July 26 at the 19th International AIDS Conference. While the specific causes of the increased cardiovascular risk with HIV are unclear, one popular theory is that heightened inflammation plays a significant role in promoting a prothrombotic state, according to Meagan O'Brien, MD, New York University Medical School, New York, New York, and colleagues. READ MORE...


HIV, Even with Treatment, Hikes HCV Liver Risks

People with both HIV and hepatitis C (HCV) are at increased risk for hepatic decompensation – even if they are on effective antiretroviral therapy -- compared with people who have only the liver disease, a researcher reported here. In a large retrospective cohort, those with both viruses had a 6.3% rate of decompensation compared with 5% for those with just HCV. READ MORE...


FDA Approves OraQuick Home HIV Antibody Test
On July 3, 2012, the U.S. Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test, the first over-the-counter self-administered HIV antibody test that can be performed entirely outside a medical setting. The FDA's Blood Products Advisory Committee unanimously voted to recommend approval of the test in May. Although the test can sometimes give false-negative or false-positive results, the FDA concluded that the benefits of more people learning their HIV status outweigh the potential drawbacks. READ MORE...

Latest AIDSVu Data Illustrate Impact of HIV by ZIP Code in Major U.S. Cities

Today, on the eve of National HIV Testing Day, the Rollins School of Public Health at Emory University unveiled a major update of AIDSVu (www.aidsvu.org), including new interactive online maps that, for the first time, show the latest HIV prevalence data for 13 U.S. cities by ZIP code or census tract. AIDSVu also allows users to view HIV rates alongside key social determinants of health – such as poverty, lack of health insurance, and educational attainment. READ MORE...

Doctors in Europe and the US disagree over the pace off liver fibrosis in men co-infected with HIV and hepatitis C
Doctors in Europe and the US have conflicting opinions about the pace of liver fibrosis in HIV-positive men with hepatitis C infection. In a study published in Clinical Infectious Diseases, European investigators showed that the pace of liver fibrosis slowed after the acute phase of infection. However, doctors from the US have published contrasting findings, showing that fibrosis continued to worsen with longer duration of co-infection.
READ MORE...

Choosing Alcohol Over HIV Meds? New Study Examines Why People With HIV Skip Treatment When Drinking
Half of HIV-positive individuals who are on treatment and drink alcohol skip taking their HIV medications on purpose, under the erroneous belief that mixing antiretrovirals and alcohol is harmful, according to a
prospective study presented at the 7th International Conference on HIV Treatment and Prevention Adherence. READ MORE…


HIV Treatment May Lower Risk of Precancerous Anal Lesions
Potential good news for HIV-positive men who have sex with men: Antiretroviral therapy may reduce the prevalence of precancerous anal lesions and infection with the cancer-causing human papillomavirus (HPV), according to a
new study published in the July issue of the journal Sexually Transmitted Diseases. READ MORE…

HIV therapy affects bone mass within 2 years
Young men receiving antiretroviral therapy (ART) for recently diagnosed HIV are more likely to have low bone mineral density (BMD) than are other men of a similar age, US researchers report.
READ MORE…

Addition Nevirapine to HIV Treatment Reduces Risk of Newborns' Contracting Virus
Addition of nevirapine drug to the treatment given to newborns of women detected with HIV just before or during labor, reduces the risk of newborns' contracting the virus to half, according to a study by a National Institutes of Health research network. The results of the study showed that around the time of delivery, the rate of mother-to-child HIV transmission was 2.2 percent among infants who were given drug zidovudine with nevirapine than 4.8 percent among infants treated with zidovudine alone.
READ MORE…

Booster dose of measles vaccine achieves high levels of protection for children taking effective HIV treatment
A booster dose of the measles vaccine produces protective antibody responses and immunologic memory in children receiving HIV therapy, US investigators report in the online edition of the Journal of Infectious Diseases. A viral load below 400 copies/ml was associated with vaccine response.
READ MORE…

Heart Trouble Early and Often in HIV Patients

People with HIV, even those whose virus is well-suppressed by treatment, have a greater risk of heart attack than their uninfected peers, and at an earlier age, new research shows.
Dr. Priscilla Y. Hsue, a cardiologist at San Francisco General Hospital, and colleagues reported their findings, which confirm a link that some AIDS experts have long suspected, in the Journal of the American College of Cardiology.
READ MORE…

HIV/hepatitis C co-infection increases risk of hip fracture
Co-infection with HIV and hepatitis C is associated with an increased risk of hip fracture, US investigators report in Hepatology. Hepatitis C monoinfection also increased the risk of this type of fracture. The authors suggest that this elevation in the risk of fracture could be caused by the inflammatory effects of these infections, but they also think that social and lifestyle factors are likely to be important contributory factors
.
READ MORE…

New Data on the Berlin Patient: Interpret With Caution

On Friday at the
International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies in Sitges, Spain, Steve Yukl from UCSF presented new data on the case of Timothy Brown, the "Berlin Patient." Yukl described multiple experiments performed by several independent laboratories with the aim of searching intensively for any signs of residual HIV infection in plasma, peripheral blood mononuclear cells (PBMC) and biopsies from the gut and cerebrospinal fluid (CSF). The nature of these analyses is a testament to Brown's extremely laudable willingness to undergo an array of unappealing procedures in order to advance research into curing HIV. READ MORE…

FDA Approves INTELENCE® etravirine Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
Janssen Therapeutics, Division of Janssen Products, LP, announced that the U.S. Food and Drug Administration (FDA) has approved INTELENCE® (etravirine) to be administered in combination with other antiretroviral (ARV) medications for treatment of human immunodeficiency virus 1 (HIV-1) in treatment-experienced pediatric patients (6 years to less than 18 years old) who are experiencing virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs.
READ MORE...


Novel HIV Integrase Inhibitor Dolutegravir Matches Raltegravir in Phase 3 Study
ViiV Healthcare and Japan's Shionogi announced that its experimental integrase inhibitor dolutegravir (formerly S/GSK1349572) worked as well as the sole approved integrase inhibitor, raltegravir (Isentress), for people with HIV starting antiretroviral treatment for the first time.
READ MORE...

Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
Abbott (NYSE:
ABT) will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress™ 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain.
READ MORE...

Updated U.S. HIV treatment guidelines call for HIV treatment for all

The U.S. Department of Health and Human Services (HHS) released
updated HIV treatment guidelines on March 27 which, among other things, maintain that all people living with HIV in the U.S. are now eligible to receive antiretroviral therapy (ART), regardless of CD4 cell count. Previous guidance recommended ART for those HIV-infected with a CD4 cell count at or below 350, as well as between 350 and 500, but did not have a recommendation for those with a CD4 count above 500. READ MORE...

Cancer Drug Holds Potential in Combating HIV
In a development that may pave way for AIDS treatment, researchers claimed to have succeeded in attacking HIV infectivity from its hide-out with the help of a medicine used in the treatment of lymphoma, a cancer which impacts immune cells. In an experimental study, HIV-infected males taking anti-AIDS medicines were injected with the cancer medicine, vorinostat. It was observed that within a few hours, there was a considerable rise in HIV RNA within the cells, which demonstrated that the virus was flushed out from its refuge.
READ MORE!

ViiV Announces Expanded Access of Once a Day Integrase Inhibitor...But Activists Are Concerned About Its Potential Misuse
The dolutegravir expanded access program (EAP) has been designed to provide free access to Shionogi-ViiV Healthcare's investigational integrase inhibitor, dolutegravir (DTG, S/GSK1349572) in an open-label protocol program to adults living with HIV who have documented
raltegravir or elvitegravir resistance, who have limited treatment options, and who require DTG to construct a viable antiretroviral regimen for therapy. READ MORE!

Inovio Pharmaceuticals' PENNVAX®-B HIV Vaccine Demonstrates Strong T-Cell Immune Responses in Therapeutic Vaccine Trial
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO) announced that it has achieved strong T cell immune responses in a Phase I clinical study of PENNVAX®-B, its product for the treatment of the HIV subtype prevalent in North America and Europe, in HIV-positive subjects. These interim results were presented by Dr. Niranjan Y. Sardesai, Inovio's Chief Operating Officer, at the Vaccine World Summit 2012 in Hyderabad, India in a talk titled, "New Development Paradigms and Vaccine Innovation for Infectious Diseases."
READ MORE!

Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study
Gilead Sciences announced full Phase 3 clinical trial results from pivotal Study 102 demonstrating that the Quad, a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection, is non-inferior to Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) after 48 weeks of therapy in treatment-naïve adults. Atripla is currently the most-prescribed HIV treatment regimen in the United States. The Study 102 findings were presented today in an oral session (Abstract #101) at the 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012) taking place in Seattle.
READ MORE!

Mylan Receives Tentative FDA Approval Through PEPFAR for Pediatric HIV/AIDS Therapy
Mylan announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg. This fixed-dose combination (FDC) product was developed for use in treating children with HIV/AIDS and is based on the adult-strength, brand version of the product EPZICOM®, by Viiv Healthcare. Mylan received tentative PEPFAR approval for its adult-strength, generic version of EPZICOM on Mar. 30, 2009.
READ MORE!

 


 

 



RESOURCE NEWS


New SAMHSA Resource on Viral Hepatitis

The Substance Abuse and Mental Health Services Administration (SAMHSA) has released a new Treatment Improvement Protocol (TIP), Addressing Viral Hepatitis in People With Substance Use Disorders. The new TIP is designed to assist behavioral health professionals who treat people with substance abuse problems to understand viral hepatitis prevention, care, and treatment and how these issues can be integrated into substance abuse treatment programs to better address the needs of their clients who are at risk for or infected with viral hepatitis. This document is written using everyday language and includes visual aids that help to explain many of the technical aspects of hepatitis B and hepatitis C disease progression, testing, and treatment. View the TIP.

Updated Fact Sheets on HIV and Pregnancy
AIDSinfo has updated its fact sheet series on HIV and pregnancy. These fact sheets are intended for women infected with HIV who are pregnant or thinking about becoming pregnant and are based on the latest version of the Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. View the fact sheets. (PDF – 2.18MB)

 

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