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Generic Version Of Combivir Is Now Available – The generic version of Combivir (lamivudine/zidovudine), made by generic drug maker Teva Pharmaceuticals, is now available. Teva stated that it began shipping its generic form to pharmacies starting December 27. Generic Combivir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 (see related AIDS Beacon news). For more information, please see the article in Businessweek or the Teva Pharmaceuticals website.

Truvada For Prevention Of HIV Makes Time Magazine’s “Top 10 Medical Breakthroughs” For 2011 – Results from several studies showing that a daily dose of the antiretroviral Truvada (emtricitabine/tenofovir) can reduce the risk of HIV infection by 60 percent to 90 percent were declared one of the top 10 medical breakthroughs of 2011 by Time Magazine. The magazine noted that if the antiretrovirals were made widely available they could help curb the HIV/AIDS epidemic. The primary study, HPTN 052, was also chosen by Science Magazine as “2011 Breakthrough of the Year.” Gilead Sciences, which makes Truvada, applied for FDA approval to market the drug as an HIV prevention measure in December (see related AIDS Beacon news). However, Bloomberg noted that the drug costs $12,000 per year and has side effects, both of which may prevent widespread implementation. For more information, please see the articles in Time Magazine, Science Magazine, and Bloomberg.

Physicians Caution That Certain Anti-Seizure Drugs May Interfere With Antiretrovirals – New guidelines from American Academy of Neurology warn that certain anti-seizure medications, such as those taken to treat epilepsy, may interact with antiretroviral medications for HIV/AIDS. For example, the guidelines note that valproic acid (Depakote, Depakene) may increase the concentration of zidovudine (Retrovir) in the blood, increasing the risk of toxicity and side effects. Several anti-seizure medications also may interact with Norvir (ritonavir)-boosted Reyataz (atazanavir) and Kaletra (lopinavir/ritonavir). The guidelines recommend that people with HIV and seizure disorders share with their clinician what medications they are taking so that drug types and dosages can be adjusted if needed. For more information, please see the guidelines (pdf) or the patient information guide (pdf) at the American Academy of Neurology website.

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Gilead Applies For Approval For Truvada As An HIV-Prevention Drug – Gilead Sciences has applied for approval from the U.S. Food and Drug Administration (FDA) to market Truvada (emtricitabine/tenofovir) for the prevention of HIV infection. The application is based on studies showing that taking Truvada once a day helped reduce the rate of new HIV infections in high-risk populations, such as men who have sex with men, by about 70 to 90 percent when taken regularly (see related AIDS Beacon news). If approved, Gilead stated that Truvada would be the first drug approved for the prevention of HIV infection via sexual transmission in uninfected adults. For more information, please see the Gilead Sciences press release.

People With HIV May Be At Higher Risk Of Migraines – Results from a recent study indicate that people with HIV may be at a higher risk of headaches, particularly migraines, than people without HIV. The researchers found that more than half of study participants reported headaches; more than 85 percent of these patients met the criteria for migraine headaches. According to the scientists, this represents a 13-fold higher risk of chronic migraines in people with HIV compared to the general population. The researchers also found that more advanced HIV infection was associated with more severe headaches. For more information, please see the press release from the University of Mississippi or the study in the journal Headache (abstract).

2012 Federal Spending Bill Bans Needle Exchange Programs For HIV Prevention – The 2012 federal spending bill, approved by Congress last week, contains a provision that prohibits federal money from being used for needle exchange programs for illegal drug users. The programs are meant to help prevent transmission of HIV and other blood-borne diseases by ensuring that users do not share needles. The AIDS Institute, a non-profit AIDS advocacy organization, expressed disappointment with the bill and also noted that funds remained flat for programs such as the Ryan White Program, which provides money to care for low-income people with HIV. For more information, please see the article in the Washington Post or the press release from The AIDS Institute.

Florida “Faces Of HIV” Project To Launch In Tallahassee, FL – Florida state will launch its traveling “Faces of HIV” exhibit January 13 at Florida State University in Tallahassee, FL. The project showcases the faces, experiences, and daily lives of people with HIV. The aim of the exhibit is to reduce stigma against people with HIV and to demonstrate that HIV infection strikes all sexes, ages, and races and cannot be deduced from a person’s appearance. The project will also stop in Orlando, Miami, Tampa, and Jacksonville, FL. For more information, please see the Faces of HIV website at the Florida Department of Health.

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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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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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Congresswoman Lee Introduces Bill To Repeal Certain HIV Criminalization Laws – Representative Barbara Lee from California has introduced legislation that requires state officials nationwide to reevaluate HIV criminalization laws. The proposed legislation also offers incentives for states to repeal or modify laws that criminalize behavior by people with HIV that is legal for HIV-negative individuals or that has been shown scientifically to convey no measurable risk of HIV transmission. Representatives Hansen Clark and John Conyers from Michigan are co-sponsors of the bill. For more information, please see Rep. Lee’s press release or the article in the Michigan Messenger.

Large HIV Prevention Trial For Women Modified Due To Viread Inefficacy – A large trial that is testing the efficacy of Truvada (emtricitabine/tenofovir) pills, Viread (tenofovir) pills, and a Truvada vaginal gel in preventing HIV transmission to women has been modified because of interim results showing that Viread pills are ineffective. Based on the results, women in the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study who were taking Viread will stop taking the drug and will no longer be included in the study. Women taking Truvada pills or the Truvada vaginal gel will continue as planned. For more information, please see the National Institutes of Health press release or the article on the Science Magazine website.

Phase 1 Clinical Trial Shows New HIV Vaccine May Be Highly Effective – Results from a Phase 1 clinical trial of a new preventative HIV vaccine in Spain show that 90 percent of healthy HIV-negative adults who received the vaccine showed an immune response; 85 percent still had an immune response one year after vaccination. This is a much higher percentage than researchers have observed in previous vaccine clinical trials. However, the scientists still have to show that the vaccine actually reduces the risk of contracting HIV. The researchers also plan to test the vaccine as a therapeutic vaccine in people who already have HIV to see if it reduces the severity of infection. For more information, please see the press release from Consejo Superior de Investigaciones Científicas or the articles on the ABC news and Fox news websites.

Clinical Trial To Test Victrelis In People With HIV And Hepatitis C Is Currently Recruiting Participants – A Phase 4 clinical trial that will test the efficacy of Victrelis (boceprevir) in HIV-positive adults with hepatitis C virus compared to HIV-negative adults with hepatitis C is currently recruiting participants. Study participants will receive Victrelis in combination with peginterferon-2b (PegIntron) and ribavirin (Rebetol). Eligible participants must not have taken the antiretrovirals Ziagen (abacavir), zidovudine (Retrovir), didanosine (Videx), stavudine (Zerit), Sustiva (efavirenz), or Intelence (etravirine) within the past six months. Additional medication and health restrictions also apply. For more information, please see the U.S. Clinical Trials Registry.