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People With HIV Are At Increased Risk Of Six Cancers – Results from a recent study indicate that people with HIV are at an increased risk of developing Kaposi’s sarcoma, non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, melanoma, anal cancer, and liver cancer compared to people without HIV. The researchers also found lung and oral cancers more frequently in people with HIV, but attributed this to lifestyle factors such as higher smoking rates. There was no increased risk of colorectal cancer and a reduced risk of prostate cancer. Results also showed that lower CD4 (white blood cell) counts were associated with an increased cancer risk. Higher viral load (amount of HIV in the blood) was only linked with a higher risk of Kaposi’s sarcoma and non-Hodgkin’s lymphoma. For more information, please see the press release from Kaiser Permanente or the study in Cancer Epidemiology, Biomarkers & Prevention (abstract).
Gilead Receives Approval For Eviplera In Europe – The European Medicines Agency (EMA) has approved Gilead Sciences’ new once-daily combination antiretroviral pill Eviplera (rilpivirine/emtricitabine/tenofovir) for the treatment of HIV in previously untreated adults with viral loads (amount of HIV in the blood) of 100,000 copies per milliliter or less. The approval means that Eviplera can be marketed in all 27 countries in the European Union. Eviplera, known as Complera in the U.S., was approved by the U.S. Food and Drug Administration in August. For more information, please see the Gilead Sciences press release.
AIDS Deaths Continue To Drop Worldwide – An annual report from the United Nations shows that the number of deaths worldwide due to AIDS has continued to drop for the third year in a row. The number of new HIV infections also fell 21 percent in 2010 compared to 1997; 70 percent of new infections were in sub-Saharan Africa. However, the number of people on antiretrovirals increased 20 percent in 2010 in sub-Saharan Africa, bringing the total to 50 percent of clinically eligible people with HIV in low- and middle-income countries. The report also notes that due to longer lifespans and greater survival rates, the number of people living with HIV now stands at an estimated 34 million, the highest ever. For more information, please see the United Nations report (pdf) or the article in the Washington Post.
Study Finds Viread Vaginal Gel Is Safe But Ineffective For HIV Prevention – Results from the Oral Interventions to Control the Epidemic (VOICE) study indicate that a vaginal gel containing 1 percent Viread (tenofovir) is safe but ineffective at preventing HIV infection in women. Based on the results, the National Institutes of Health, which is funding the study, has decided to drop the vaginal gel from the study. The trial, whose purpose is to provide women with methods to prevent HIV infection, will continue to evaluate the safety and efficacy of Truvada (emtricitabine/tenofovir) pills instead. The VOICE study was first modified in September after results showed that a Viread pill was also ineffective (see related AIDS Beacon news). For more information, please see the National Institutes of Health press release.
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Foundation For AIDS Research Announces Additional $2.1 Million In Grants Towards AIDS Cure – The Foundation for AIDS Research (amfAR) has announced that it will distribute an additional $2.1 million in grants and fellowships to researchers working toward a cure for HIV. AmfAR states that 60 percent of its research grants now go toward research into finding a cure for HIV. Many of the grants have been awarded to scientists working on eliminating latent HIV, which is a dormant form of HIV that is not affected by antiretrovirals. Many scientists believe that activating and eliminating latent HIV is the key to a cure (see related AIDS Beacon news). For more information, please see the amfAR press release.
FDA Grants Priority Review For HIV Neuropathy Pain Relief Patch Qutenza – The U.S. Food and Drug Administration (FDA) has granted biopharmaceutical company NeurogesX a priority review for its capsaicin patch Qutenza, which is currently being evaluated for the treatment of pain from HIV-associated neuropathy. The decision means that the FDA will review the application for approval of Qutenza in six months rather than the usual 10 months. NeurogesX stated that it expects a decision from the FDA on March 7, 2012. Neuropathy is a condition that causes pain, numbness, burning, or tingling in the extremities. Qutenza is a capsaicin patch that is placed on the skin for 30 minutes. If approved, it would be the first product in the U.S. indicated for the treatment of pain from HIV-related neuropathy. It is currently approved for treatment of nerve pain due to shingles. For more information, please see the NeurogesX press release.
World AIDS Day Is December 1 – December 1 marks the 23rd World AIDS Day, a day set aside to remember those who have passed from the disease, acknowledge those who are living with HIV and AIDS, and spread awareness of its impact around the globe. The theme of this year’s AIDS day is “Getting to Zero,” which refers to zero new infections, zero new deaths from AIDS, and zero discrimination against people with HIV. Cities around the nation and the world will be holding events to mark World AIDS Day. For more information on participating or to register an event, please see the AIDS.gov website. For more information on World AIDS Day, please see the international World AIDS Day website.
Redesigned AIDSinfo Website To Debut On World AIDS Day – AIDSinfo, a website maintained by the U.S. Department of Health and Human Services, has been redesigned; the new design will debut on World AIDS Day, December 1. In addition, the Spanish version of the site, infoSIDA, will now have its own web address at www.infoSIDA.nih.gov. The AIDSinfo websites bring federal information regarding HIV and AIDS research, treatments, prevention, and medical practices to the public, with a specific focus on clinical research information and medical guidelines related to the care of people with HIV and AIDS. For more information, please see the AIDSinfo website.
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Merck To Collaborate With The Vaccine And Gene Therapy Institute On HIV Latency Research – U.S. pharmaceutical company Merck has entered into a three-year agreement with the Vaccine and Gene Therapy Institute of Florida to collaborate on research into HIV latency. Latent HIV is a dormant form of HIV that is not actively replicating and therefore is not eliminated by antiretroviral drugs. The research is part of an effort toward finding a cure for HIV and will focus on methods to target latent HIV and test latency drug candidates. Many scientists believe HIV could be cured by combining antiretrovirals with drugs to activate and target latent HIV (see related AIDS Beacon news). For more information, please see the press release from the Vaccine and Gene Therapy Institute of Florida.
Secretary Of State Clinton Calls For AIDS-Free Generation – Secretary of State Hillary Clinton called for the world to work toward an AIDS-free generation in a speech at the National Institutes of Health last week. Secretary Clinton advocated the use of antiretroviral drugs in combination with prevention measures such as male circumcision and promotion of condom use to cut the number of HIV infections. Secretary Clinton stated that the U.S. would grant $60 million toward these efforts in sub-Saharan Africa. Clinton also appointed talk show host Ellen DeGeneres as an international envoy for AIDS awareness. For more information, please see the article in the Washington Post.
Magic Johnson Marks 20 Years Of Living With HIV – Last week marked the 20th anniversary of basketball player ‘Magic’ Earvin Johnson’s announcement that he would retire from the Los Angeles Lakers due to HIV infection. At the time, in 1991, people with HIV were not expected to live very long. Last week, Johnson said that if he had known how well he would live with HIV he would not have retired. Since going public with his HIV infection, Johnson has been an active member of the HIV/AIDS community, including starting the Magic Johnson Foundation to help fight HIV and serving as a United Nations Ambassador of Peace. For more information, please see the Associated Press article.
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Isentress Prescribing Information Updated To Warn Of Severe Rash – The U.S. Food and Drug Administration (FDA) recently announced that the prescribing information for Isentress (raltegravir) has been updated to include a warning about the risk of a severe, potentially life-threatening rash. According to the FDA, patients taking Isentress should immediately contact their physician if they develop a rash. Physicians should advise patients to immediately stop taking Isentress if they develop a rash and have one or more of the following symptoms: fever, a general feeling of illness, extreme tiredness, muscle or joint aches, blisters, mouth lesions, eye inflammation, facial swelling or swelling of the eyes, lips, or mouth, breathing difficulties, or signs of liver problems (such as yellowing of the skin or eyes or pain under the ribs). For more information, please see the FDA press release.
AIDS Patients Sue Ohio Department Of Health Over New ADAP Regulations – Three HIV-positive patients and advocates have sued the Ohio Department of Health over new restrictions to the state’s AIDS Drug Assistance Program (ADAP), which provides free antiretrovirals to low-income people with HIV. According to the lawsuit, Department of Health officials failed to follow state laws on adopting new regulations, making them illegal. The plaintiffs also argue that the regulations would arbitrarily deny treatment to people with HIV. The new regulations would allow the Department to tighten restrictions on patient income for ADAP eligibility; they also include medical guidelines to determine waitlist priority if a waitlist is needed. A judge granted an injunction last week delaying implementation of the new regulations until the lawsuit has been resolved. For more information, please see the article on the New England Cable News website or the AIDS Healthcare Foundation press release.
Vertex Pharmaceuticals To Initiate Phase 3 Trial Of 12-Week Hepatitis C Regimen – Vertex Pharmaceuticals, the developer of Incivek (telaprevir), announced last week that it will initiate a Phase 3 trial of a 12-week hepatitis C treatment regimen consisting of Incivek, peginterferon-alfa, ribavirin, and its investigational hepatitis C virus polymerase inhibitor VX-222. The trial will test the regimen in both previously untreated and relapsed hepatitis C patients. The announcement of the new trial is based on results from a Phase 2 clinical trial that showed that 93 percent of patients treated with the four-drug regimen were cured of hepatitis C after 12 weeks. For more information, please see the Vertex Pharmaceuticals press release.
Bristol-Myers Squibb Investigates 12-Week, Interferon-Free Hepatitis C Treatment Regimen – Bristol-Myers Squibb is also independently investigating a 12-week, interferon-free treatment regimen for the treatment of hepatitis C. Bristol-Myers Squibb announced that it is adding the new 12-week treatment protocol to an existing Phase 2 clinical trial that is testing the same regimen as a 24-week treatment program. Patients will receive the investigational polymerase inhibitor PSI-7977 (developed by Pharmasett) plus Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir (BMS-790052). Some patients will also receive ribavirin. The trial will test the regimens in both previously untreated patients and patients who have failed treatment with Incivek or Victrelis. For more information, please see the Bristol-Myers Squibb press release.
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Bristol-Myers Squibb, Gilead To Create New, Boosted Reyataz Pill – Bristol-Myers Squibb and Gilead Sciences announced an agreement last week to create a new, all-in-one boosted Reyataz (atazanavir) pill. The pill will contain Gilead Science’s investigational booster cobicistat. The combination of Reyataz and cobicistat is being evaluated in Phase 2 and Phase 3 clinical trials. Under the agreement, Bristol-Myers Squibb will be responsible for marketing the new drug. Boosting agents are used to increase the concentration of another drug in the bloodstream and allow patients to take drugs less often without losing efficacy. Currently the only antiretroviral booster approved by the U.S. Food and Drug Administration is Norvir (ritonavir). For more information, please see the press release from Bristol-Myers Squibb.
HIV Drug Patch Shows Efficacy In Preclinical Tests – Results from preclinical studies indicate that a new investigational skin patch is effective at delivering antiretroviral drugs. The patch contained a non-nucleoside reverse transcriptase inhibitor that is in early stages of development. Results showed that the patch successfully released 96 percent of the drug over seven days. The study authors stated that the skin patch could be an easier alternative to pills for people with HIV who have problems with adherence. The patch will be tested further in a Phase 1 clinical trial. For more information, please see the study abstract (pdf) and press release at the American Association of Pharmaceuticals Scientists website or the U.S. News and World Report article.
HPV Vaccine May Prevent Anal Cancer In Men Who Have Sex With Men – Results from a large international study indicate that the human papillomavirus (HPV) vaccine Gardasil effectively prevents anal pre-cancerous lesions in men who have sex with men. The study included 602 men aged 16 to 26 years old. Results showed that the vaccine reduced the rate of pre-cancerous lesions by 78 percent. To be effective the vaccine must be given before men acquire HPV, which causes most cases of anal cancer. Researchers have estimated that people with HIV are 30 to 50 times more likely to get anal cancer than people without HIV, and men who have sex with men are around 60 times more likely to get anal cancer. For more information, please see the study in the New England Journal of Medicine (abstract) or the article from Agence France-Presse.
United States Conference On AIDS Begins November 10 – The 2011 United States Conference on AIDS (USCA) will be held November 10 to 13 in Chicago. Topics covered during the conference include HIV prevention, treatment, and research as well as housing and public policy. Among the speakers are David Furnish, Chairman of the Elton John AIDS Foundation; Mondo Guerra, the HIV-positive former contestant from the television show Project Runway; and Senator Jack Jackson (AZ), a member of the President’s Advisory Council on HIV/AIDS. Over 3,000 people are expected to attend this year’s conference. For more information or to register for the conference, please see the USCA 2011 website.