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.

FDA Accepts Gilead’s Application For Approval Of “Quad” Combination Antiretroviral – The U.S. Food and Drug Administration (FDA) has accepted Gilead Science’s application for approval of its investigational “Quad” combination antiretroviral pill. The Quad regimen is a fixed-dose, single tablet consisting of the investigational booster drug cobicistat, the investigational integrase inhibitor elvitegravir, and Truvada (emtricitabine/tenofovir). Gilead submitted its application to the FDA in October; the FDA has stated that it will make a decision on the drug by August 27, 2012. For more information, please see the Gilead Sciences press release.

Gilead Files For Approval Of “Quad” Combination Antiretroviral In Europe – Gilead Sciences has also applied for marketing approval of its investigational “Quad” combination antiretroviral pill from the European Medicines Agency (EMA). If approved, the Quad will be the third all-in-one combination antiretroviral pill approved in Europe; the first two, also marketed by Gilead Sciences, were Atripla (efavirenz/emtricitabine/tenofovir) and Eviplera (rilpivirine/emtricitabine/tenofovir), known as Complera in the U.S. Based on average approval times for the EMA, a decision would be expected mid to late next year. For more information, please see the Gilead Sciences press release.

Merck Agrees To Cut Price Of Isentress For ADAPs – U.S. pharmaceutical company Merck has agreed to lower its price for Isentress (raltegravir) for state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. The agreement follows pledges by Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) to also reduce the prices they charge ADAPs for their HIV drugs (see related AIDS Beacon news). Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. For more information, please see the Merck 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.

Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company 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. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

Phase 3 Trial Results Show Gilead’s Investigational Booster Cobicistat Is Effective And Safe – Interim 48-week results from an ongoing Phase 3 clinical trial show that Gilead Science’s investigational boosting agent cobicistat is as effective as Norvir (ritonavir). Boosting agents are drugs that allow patients to take medications less often without losing efficacy. Results showed that 85 percent of previously untreated adults with HIV who took cobicistat-boosted Reyataz (atazanavir) plus Truvada (emtricitabine/tenofovir) successfully achieved undetectable viral loads (amount of HIV in the blood), compared to 87 percent of study participants taking Norvir-boosted Reyataz plus Truvada. Discontinuation rates due to side effects were similar between the two groups of participants. Based on the results, Gilead stated that it would apply for approval of cobicistat from the U.S. Food and Drug Administration in the second quarter of 2012. For more information, please see the Gilead Sciences press release.

Supreme Court To Decide On Government Liability For Breaches Of HIV Privacy – Justices for the U.S. Supreme Court will hear arguments this week on whether the federal government can be held liable for emotional distress when it illegally discloses a person’s HIV status. The government was sued by an HIV-positive pilot whose status was disclosed to officials at the Federal Aviation Administration by officials in the Social Security Administration, violating medical privacy laws. The government argues that it is only responsible for damages due to economic losses from such violations, not emotional distress. For more information, please see the article in the Los Angeles Times.

Merck Initiates Anti-Stigma Initiative For People With HIV And Their Clinicians – U.S. pharmaceutical company Merck has announced a new anti-stigma initiative to improve health care and communication between people with HIV and their clinicians. The program, called Clinic Activation to Lead and Implement Best Practices for Enhancing Response to HIV (CALIBER), includes a website with a discussion guide on dealing with and reducing stigma related to HIV and an expert panel of physicians to help answer stigma-related questions. For more information, please see the Merck press release (pdf) or the CALIBER website.

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.

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.

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.

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.

Basándose en los resultados, el Dr. Norbert Bischofberger, vicepresidente ejecutivo de Investigación y Desarrollo y director científico de Gilead Sciences, declaró en un comunicado de prensa que Gilead comenzará a trabajar en la aprobación de la pastilla “Quad” a finales de año, en lugar de a principios del año que viene, como se había afirmado previamente.

“La tasa de respuesta del 90 por ciento observada en la sección “Quad” de este estudio supone un resultado sin precedentes y da testimonio de la potencia, seguridad y comodidad de un régimen de una única pastilla basado en la integrasa “,  dijo el Dr. Bischofberger.

Los resultados del estudio suponen el segundo conjunto de resultados de “Quad” que se da a conocer este año: en agosto, Gilead dio a conocer los resultados de otro estudio en fase 3 que demuestran que la píldora Quad es tan eficaz como la Atripla, el tratamiento de primera línea prescrito con mayor frecuencia para el tratamiento del VIH (lea la noticia relacionada en el AIDS Beacon, en inglés).

El régimen Quad consiste en una dosis fija, en una sola pastilla que combina el medicamento de refuerzo aún en desarrollo cobicistat, el inhibidor de la integrasa también en desarrollo elvitegravir y la Truvada (emtricitabina / tenofovir).

De acuerdo a las recomendaciones de tratamiento en los Estados Unidos, el Reyataz (atazanavir) combinado con la Truvada se considera el régimen antirretroviral de preferencia para las personas con VIH que reciben tratamiento por primera vez.

El estudio actual incluye a 708 adultos con VIH que no habían recibido tratamiento con antirretrovirales con anterioridad  y que presentaban una carga viral (cantidad de VIH en la sangre) de al menos 5000 copias por mililitro al inicio del estudio. Se asignó aleatoriamente a la mitad de los participantes para que tomaran la pastilla “Quad” una vez al día, y al resto se le asignó  tomar Reyataz reforzado con Norvir (ritonavir) y combinado con Truvada.

Los resultados demostraron que, transcurridas 48 semanas, el 90 por ciento de los participantes que tomaban la pastilla Quad había conseguido alcanzar una carga viral indetectable, frente al 87 por ciento de los participantes que tomaron Reyataz reforzado y Truvada.

Hubo más participantes que suspendieron el tratamiento debido a los efectos secundarios entre los que tomaban Reyataz y Truvada (un 5.1 por ciento de los participantes) que entre los que tomaban la pastilla Quad (un 3.1 por ciento). La diferencia fue debida principalmente a los altos niveles de bilirrubina en los participantes que tomaron Reyataz, un efecto secundario conocido del Reyataz que puede causar ictericia

Gilead informó que el resto de efectos secundarios tuvieron una incidencia parecida en los dos grupos del estudio.

Gilead tiene previsto presentar los resultados provisionales del estudio con más detalle en una conferencia científica a principios del año que viene. El estudio está aún en curso y continuará hasta que todos los participantes hayan recibido seguimiento durante 96 semanas.

Para obtener más información, por favor consulte el comunicado de prensa de Gilead (en ingles).