Gilead’s “Quad” Pill Enters Phase 3 Trials
President Obama Widens Medical Rights for LGBT Partners and Families
Law Enforcement and Harm Reduction Network (LEAHRN) Website Launched
Gilead’s “Quad” Pill Enters Phase 3 Trials
On April 12, Gilead Sciences, Inc. issued a press release announcing that it has “dosed the first patient in the Phase 3 clinical program evaluating its investigational fixed dose, single tablet ‘Quad’ regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate [Truvada]. The Phase 3 clinical program for the Quad includes two studies (Studies 102 and 103) that will evaluate the Quad regimen versus a standard of care among HIV-1 infected antiretroviral treatment-naïve adults.” Elvitegravir is Gilead’s integrase inhibitor currently in development, which must be taken with a booster.
“We are pleased to announce that the Quad Phase 3 clinical program is underway,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Efficacy and safety results from the Phase 2 study suggest that the Quad may represent an important new option for patients with HIV. We look forward to further defining the clinical profile of the Quad in a larger number of patients in the Phase 3 trials.”
According to the release, Gilead is also examining cobicistat as a stand-alone boosting agent for other antiretrovirals, in particular protease inhibitors, which is currently the role of Norvir (ritonavir). Gilead plans to initiate a Phase 3 clinical trial “evaluating the efficacy, safety and tolerability of cobicistat-boosted atazanavir compared to ritonavir-boosted atazanavir, each in combination with Truvada (emtricitabine and tenofovir disoproxil fumarate).”
The primary endpoint of both Quad studies will be the proportion of patients achieving HIV RNA levels of less than 50 copies/mL at 48 weeks of treatment. Secondary objectives will evaluate the efficacy, safety, and tolerability of the treatment regimens through 96 weeks of treatment. After week 96, subjects will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all subjects will be given the option to participate in an “open-label rollover extension” and receive the Quad single-tablet regimen.
Discuss this news in our discussion forum
President Obama Widens Medical Rights for LGBT Partners and Families
Last week, President Obama issued a memo to Health and Human Services Secretary Kathleen Sebelius directing that rules be established that “ensure that hospitals that participate in Medicare or Medicaid respect the rights of patients to designate visitors.” The rules will also guarantee “that all patients’ advance directives, such as durable powers of attorney and health care proxies, are respected.”
The rules change was inspired by the case of same-sex couple Janice Langbehn and Lisa Pond, who were profiled in The New York Times last year. After Ms. Pond was stricken with a fatal brain aneurysm, Ms. Langbehn, her partner of 18 years, was denied visiting rights by a Florida hospital. Although Ms. Langbehn had power of attorney and she and Ms. Pond were parents to four children they had adopted, the hospital refused, for eight hours, to allow her and the children to see Ms. Pond. Ms. Pond died as Ms. Langbehn tried in vain to get to her side.
“Every day, all across America, patients are denied the kindness and caring of a loved one at their sides,” Mr. Obama said in the memorandum, adding that the rules could also help widows and widowers who rely on friends, and members of religious orders who care for one another. But he says gay men and lesbians are “uniquely affected” because they are often barred from visiting partners with whom they have spent decades.
Richard Socarides, who advised President Bill Clinton on gay rights issues, said that while the memorandum on its own did not grant any new rights, it did “draw attention to the very real and tragic situations many gays and lesbians face when a partner is hospitalized.”
Gay rights groups called it a major advance for the families of lesbians, gay men, bisexuals, and transgender individuals.
“It’s a huge deal,” said David Smith, vice president of policy for the Human Rights Campaign, which worked with the White House to develop the memorandum. “Nearly every hospital in the country will now be required to provide hospital visitation rights to LGBT families. It’s an enormous step. In the absence of equal marriage rights in most jurisdictions, this step provides an essential right to LGBT families for a gay person or a lesbian person to spend time with their partner in a critical situation.”
Discuss this news in our discussion forum
Law Enforcement and Harm Reduction Network (LEAHRN) Website Launched
In an attempt to “bring law enforcement and harm reduction closer together,” a new website has been developed, according to a press release issued by LEAHRN. Specifically designed for police and other law enforcement personnel, “LEAHRN seeks to promote harmony and a better understanding between police and health service providers so that more programs involving clean needles and syringes, methadone, condoms, and supervised injecting facilities can be successfully delivered.”
The website is still in its formative stages and will undergo further development over the next few weeks, including additional resources and updated information being added regularly. Visit www.leahrn.org.
Discuss this news in our discussion forum
In an April 19 press release, Shanti and the New Orleans AIDS Task Force (NO/AIDS) announced that they would be offering the New Orleans region’s first access to L.I.F.E., a 13-week health-enhancement program. NO/AIDS becomes the nation’s seventeenth site to offer L.I.F.E., and the only site located in Louisiana or its surrounding states.
L.I.F.E., which stands for Learning Immune Function Enhancement, incorporates the latest research in HIV, immunology, and health into a holistic model of care which empowers persons living with HIV to improve their health. During 13 weekly sessions, participants gain the knowledge, motivation, skills, and support necessary to manage biological, psychological, and social life issues that can impact immune functioning and overall health. Participation is free, and open to all persons living with HIV/AIDS in New Orleans.
NO/AIDS Task Force, one of the oldest and largest AIDS service organizations in the Gulf South, has been providing services at low to no cost to those impacted by HIV and AIDS for over 26 years.
“NO/AIDS Task Force is excited to be able to bring the L.I.F.E. program to New Orleans,” said Noel Twillbeck, Executive Director of NO/AIDS task Force. “We are thrilled to be able to offer a program that addresses not only the physical complications of HIV-disease, but also the mental, emotional, social, and spiritual complications. As a result, we are making the L.I.F.E. program open to anyone living with HIV in the community, not just NO/AIDS clients.”
“We’ve seen participants gain amazing results from L.I.F.E.: their highest CD4+ counts since diagnosis, returning to work for the first time in years, or regaining life purpose and long term goals,” said Clayton Robbins, Director of Program Development at the Shanti L.I.F.E. Institute in San Francisco, California.
Enrollment for the first L.I.F.E. workshop in New Orleans is now open. Space is limited and participants must register. Contact Brian Shearer, NO/AIDS Task Force Peer Support Coordinator at (504) 821-2601, ext. 233, or brains@noaidstf.org. The first workshop will begin on Thursday May 6th. The project is made possible through a grant from the Gilead Foundation.
Discuss this news in our discussion forum
