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Congress Launches Congressional HIV/AIDS Caucus – Five representatives of Congress announced the launch of the Congressional HIV/AIDS Caucus last week. The goals of the Caucus are to maintain U.S. leadership in the fight against HIV and AIDS in the U.S. and internationally and to prepare for the International AIDS Conference in Washington, D.C., next year. The Caucus is co-chaired by Representative Jim McDermott from California, Representative Trent Franks from Arizona, and Representative Barbara Lee from California. It will have 59 members at its launch; additional members are expected to join in the coming weeks. For more information, please see the announcement on the Aids.gov website.

EMA Advisory Committee Recommends Approval For Edurant And Eviplera In Europe – An advisory committee to the European Medicines Agency (EMA) has recommended that Edurant (rilpivirine) be approved 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. Edurant is marketed outside the U.S. by the pharmaceutical company Janssen, a unit of Johnson & Johnson. The committee also recommended that Gilead Sciences’ new once-daily combination antiretroviral pill Eviplera (rilpivirine/emtricitabine/tenofovir), known as Complera in the U.S., be approved for the same patient population. The recommendations improve the chances for approval of the drugs in Europe; a decision is expected within two to three months. Edurant was approved in the U.S. in May, and Complera was approved in August. For more information, please see the Johnson & Johnson and Gilead Sciences press releases.

Gene Therapy Successfully Reduces Viral Loads In People With HIV (ICAAC 2011) – Sangamo Biosciences released updated results on its Phase 1 gene therapy clinical trial last Sunday showing that the treatment successfully reduced viral loads (amount of HIV in the blood) in all six of the trial’s participants without the use of antiretroviral drugs. One participant, who had a genetic variation that makes people naturally more resistant to HIV, successfully achieved an undetectable viral load. Sangamo reported no major side effects from the treatment. The results were presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. Sangamo previously reported that the gene therapy treatment increased CD4 (white blood cell) counts in people with HIV (see related AIDS Beacon news). For more information, please see the Reuters article or the Sangamo Biosciences press release.

Bristol-Myers Squibb Reports 83 Percent Hepatitis C Cure Rate In Phase 2 Study (ICAAC 2011) – Results from a Phase 2 clinical trial indicate that Bristol-Myers Squibb’s investigational hepatitis C drug BMS-790052 yielded an 83 percent cure rate after 48 weeks in previously untreated adults with genotype 1 hepatitis C when combined with peginterferon alfa-2a (Pegasys) plus ribavirin (Copegus, Rebetol). Eight percent of participants reported serious side effects (anemia, or low red blood cell counts). Based on the results, Bristol-Myers Squibb has initiated a Phase 3 clinical trial with the drug. The results were presented last Saturday at ICAAC. For more information, please see the study (abstract) at the ICAAC website or the Bristol-Myers Squibb press release. For more information on the Phase 3 clinical trial, please see the U.S. Clinical Trials Registry.

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The Department of Health and Human Services (HHS) updated antiretroviral treatment guidelines to state that Edurant, which is also a component of Complera, is considered an alternative, but not preferred, antiretroviral for people starting HIV treatment for the first time.

Sustiva (efavirenz), which is in the same antiretroviral class as Edurant (rilpivirine) and an ingredient in Atripla (efavirenz/emtricitabine/tenofovir), is still considered the preferred treatment.

Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson. Edurant was approved by the U.S.…

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The United States Food and Drug Administration (FDA) today approved Complera, informally known as “Btripla,” for use in people with HIV who have not previously been treated with antiretrovirals.

Complera will be marketed by Gilead Sciences. According to a representative from the company, Complera will be available in the U.S. starting early next week.

“Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients,” said John Martin, chairman and chief executive…

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Texas AIDS Drug Assistance Program Faces Budget Shortfall – The Texas AIDS Drug Assistance Program has failed to secure additional funding and will face budget shortages starting in September 2012. State officials have said that they will likely implement cost-cutting measures, such as excluding more expensive HIV drugs and asking pharmaceutical companies for discounts, to mitigate the shortages. The Texas legislature had previously decided not to give the program an additional $19 million to prevent cutbacks (see related AIDS Beacon news), instead deciding that the program could receive additional funds from the state’s Medicaid budget if needed. However, Medicaid also faces a $4.8 billion shortfall, making such assistance unlikely. For more information, please see the Associated Press article.

GeoVax Adds Los Angeles Site To Phase 1 Trial Of Therapeutic HIV Vaccine – Biotechnology company GeoVax Labs has announced that it is adding a third location, in Los Angeles, to its Phase 1 trial of a therapeutic vaccine to treat HIV. The first two sites are in Atlanta and Birmingham, AL. The trial is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. GeoVax expects to enroll 10 participants. For more information, please see the GeoVax press release or the U.S. Clinical Trials Registry.

Tibotec Therapeutics Changes Name To Janssen Therapeutics – Tibotec Therapeutics, the maker of the HIV drugs Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine), has changed its name to Janssen Therapeutics. The name change is an attempt to create a common link between all of the Janssen companies, which are subsidiaries of Johnson & Johnson and include Janssen Pharmaceuticals and Janssen Biotech. The company’s new website includes links to information on its antiretrovirals and patient assistance programs to help low-income patients pay for the drugs. For more information, please see the Johnson & Johnson press release or the Janssen Therapeutics website.

Reminder: Free HIV Testing Today – As part of National HIV Testing day, many locations nationwide will offer free HIV testing today (see related AIDS Beacon news). To find a testing location, please see the Centers for Disease Control’s National HIV Testing Day website.

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Gilead Sciences Receives Subpoena On Manufacturing, Quality, And Distribution Of HIV Drugs – Gilead Sciences has received a subpoena from the U.S. Department of Justice requesting information on its manufacturing, quality, and distribution practices for several drugs, including Atripla (efavirenz/emtricitabine/tenofovir), Emtriva (emtricitabine), Truvada (emtricitabine/tenofovir), Viread (tenofovir), and the proposed combination pill of Truvada plus Edurant (rilpivirine). Gilead has not disclosed the reason for the subpoena but says it will cooperate in the related civil and criminal investigations. For more information, please see the Gilead Sciences press release.

Spring Issue Of ‘Mental Health AIDS’ Is Now Available – The federal government’s Substance Abuse and Mental Health Services Administration (SAMHSA) has released the spring issue of its quarterly newsletter ‘Mental Health AIDS.’ The newsletter covers psychological and mental-health related issues in people with HIV. This issue focuses primarily on prevention, but also discusses topics such as the approval of Egrifta (tesamorelin), factors affecting medication adherence, and stress management. For more information, please see the Mental Health AIDS Newsletter Spring 2011 (pdf).

AIDS Play ‘The Normal Heart’ Wins Three Tony Awards – Larry Kramer’s play ‘The Normal Heart,’ about HIV/AIDS activists in New York City in the early 1980s, has won the Tony award for Best Revival of a Play. Additionally, cast members John Benjamin Hickey and Ellen Barkin won Tony awards for Best Featured Actor and Best Featured Actress, respectively, in a Play. The play opened on Broadway in April and will continue through July 10. For more information, please see the Tony Awards website or The Normal Heart website.