New Dose of Selzentry for Patients with Kidney Disease
ViiV Healthcare and Gilead Sciences Join with ADAP Crisis Task Force to Assist Struggling ADAPs
White House Hosts Meeting on HIV and African American Men
New Dose of Selzentry for Patients with Kidney Disease
On May 27, the U.S. Food and Drug Administration (FDA) reported making changes to the Selzentry (maraviroc) drug label. Selzentry is an HIV medication.
In a new contraindication, Selzentry should not be used by patients with severe renal (kidney) impairment or end-stage renal disease (ESRD) (CrCl less than 30 mL/min) who are taking potent CYP3A inhibitors or inducers (check with your doctor or pharmacist).
There is also a dose change for people with kidney disease who are experiencing certain side effects. According to an FDA press release, “Patients with impaired renal function may have cardiovascular co-morbidities and could be at increased risk of cardiovascular adverse events triggered by postural hypotension [low blood pressure when standing up, which can cause dizziness or fainting]. An increased risk of postural hypotension may occur in patients with severe renal insufficiency or in those with end-stage renal disease (ESRD) due to increased maraviroc exposure in some patients. … If patients with severe renal impairment or ESRD experience any symptoms of postural hypotension while taking 300 mg twice daily the dose should be reduced to 150 mg twice daily.”
The drug’s Medication Guide has been updated to include the statement, “People with severe kidney problems or who are on hemodialysis and are taking certain other medications should not take Selzentry. Talk to your healthcare provider before taking this medicine if you have kidney problems.” Visit www.selzentry.com.
ViiV Healthcare and Gilead Sciences Join with ADAP Crisis Task Force to Assist Struggling ADAPs
As part of ongoing efforts by the ADAP Crisis Task Force (ACTF) and the pharmaceutical industry to address the urgent and unprecedented need for funding for the AIDS Drug Assistance Program (ADAP), the ACTF announced on June 2 and June 4 respectively its agreements with Viiv Healthcare and Gilead Sciences. The ACTF has negotiated agreements with other pharmaceutical companies Abbott Labs, Merck Pharmaceuticals and Tibotec Therapeutics to help HIV-positive people gain access to antiretroviral medicines through ADAP. Negotiations continue with Boehringer Ingelheim, Bristol-Myers Squibb, and Genentech.
According to the June 2 release, ViiV Healthcare has agreed to add additional discounts to the country’s ADAPs on the most widely used HIV medicines produced by ViiV Healthcare, beyond those mandated by health reform and included in previous agreements with the ACTF.
“ViiV Healthcare recognizes that now, more than ever, swift action must be taken to stem the dramatic and increasing gap that exists with patients’ access to HIV medicines through ADAPs. We are committed to doing all that we can to ensure that the needs of HIV patients are met,” said Bill Collier, head of North America, ViiV Healthcare.
Gilead Sciences announced the following initiatives in the June 4 release:
- Additional discounts and extension of pricing freezes to ADAPs for Truvada Viread, and Emtriva through December 31, 2013
- Expanded eligibility for Gilead’s patient assistance program
- Elimination of minimum payment for patients through Gilead’s co-pay assistance program
- Support for creation of a “universal” patient assistance application
“Gilead is committed to ensuring that a drug’s price is never a barrier to access for those in need,” said Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences.
The National Alliance of State and Territorial AIDS Directors (NASTAD) routinely monitors the status of ADAP programs. As of May 20, there were 1,143 individuals in ten states on waiting lists for ADAP, as opposed to 99 in May of 2009. In addition to waiting lists, 16 states have implemented other cost-cutting measures such as lowering financial eligibility criteria, removing drugs from their formularies and limiting expenditures.
“As ACTF, community groups, and industry have come together to address the current crisis in ADAPs, we ask that individuals…contact their legislators to voice support for an emergency appropriation to close the funding gap for ADAPs across the country,” declared Julie Scofield, NASTAD’s Executive Director.
For more information, visit www.NASTAD.
White House Hosts Meeting on HIV and African American Men
On June 2, The White House Office of National AIDS policy hosted a meeting to discuss the issue of HIV/AIDS in African American men. The meeting convened experts on HIV/AIDS including black men living with HIV. Attendees talked about the HIV/AIDS epidemic among African American men. Topics included the federal and community responses to the epidemic, and reducing the overall stigma in the black community.
To view the video (1 hour, 50 minutes) of the meeting, click here.
According to a story in The Washington Post on June 9, Shannon L. Hader has abruptly resigned as director of the district’s HIV/AIDS administration. Hader's three-year stint made her the longest-serving director in almost 10 years.
Hader's resignation is effective July 15 and the administration's chief medical officer, Nnemdi Kamanu Elias, will serve as interim director.
According to the report, “Although Hader is departing to praise, the announcement of her resignation struck some as strange. The mayor's news release announcing Elias's ascension to the top job did not mention Hader. In his remarks, Pierre Vigilance, director of the city's Department of Health, barely acknowledged the woman who had addressed the District's top health priority, fueling speculation that there had been tension between them.”
When Hader arrived in August 2007, the district’s HIV/AIDS administration was a “laughingstock,” criticized for financial problems and managerial dysfunction and even underwent a Washington Post investigation in 2009 that found that “some groups contracted to provide services failed to get a business license and file tax returns. Others spent lavishly on travel.” David Catania, D.C. Council member and one of Hader’s supporters, maintains that the paper focused on issues that she’d inherited from the previous administration and that she was working to change them.
Toni Young, director of the Community Working Group, which tests city residents and distributes condoms, said Hader knew how to analyze data and make a case that put heterosexual infection on the radar screen.
"I think it's going to be a challenge without her leadership," Young said.
Some of the biggest names in soccer will be playing in the World Cup in South Africa, but winning games won’t be their only mission. The soccer players and some of South Africa's biggest sports stars are all part of the Brothers for Life Campaign which promotes HIV prevention and the end of violence against women and children in the country and Southern Africa.
Though not well known to American sports fans, French soccer star Thierry Henry (pictured above), Matthew Booth, Teko Modise, Lionel Messi, cricket captain Graeme Smith and rugby players John Smith and Tiger Mangweni are all part of the Brothers for Life team.
South African Deputy President Kgalema Motlanthe called on all men to join the fight against HIV and AIDS. "When good men don't stand up to be counted, HIV and AIDS spreads. When good men are silent when other men brag about committing sexual violence against their partners, HIV and AIDS spreads. Real men speak up and condemn abuse and mistreatment of women and girl-children," he said.
The sport stars' participation in the campaign has been welcomed by the South African and United States governments and the United Nation's Children Fund (UNICEF), all of which support the initiative.
UNICEF representative Elhadj As Sy said, "Men have the power to make an enormous difference in their own lives and in the lives of their children and partners. They must take responsibility, put an end to gender-based violence and participate in HIV prevention efforts. They have to refrain from risk-taking behavior such as alcohol and drug abuse. The Brothers for Life Sports Ambassadors campaign shows them the way."
ViiV Healthcare and Elizabeth Glaser Pediatric AIDS Foundation Partner to Expedite Treatment Access for African Children
On June 7, ViiV Healthcare and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) issued a press release announcing that ViiV Healthcare has committed $2 million over a two-year period to fund partnership with the EGPAF to expedite access to treatment for children with HIV in Lesotho, Malawi and Swaziland.
“As part of a multi-pronged strategy, the ViiV Healthcare-Elizabeth Glaser Pediatric AIDS Foundation partnership will increase early detection of HIV and access to antiretroviral therapy (ART) for more HIV-positive infants and young children; strengthen government leadership and policies around pediatric HIV/AIDS; and improve the quality and use of pediatric care and treatment data to advance the effectiveness of its services,” according to the release
“ViiV Healthcare has shown tremendous leadership in the fight against HIV and AIDS, and we are honored to be collaborating with them on this critical issue,” said Charles Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. “Our combined expertise will help save more children’s lives and bring about positive change more quickly than if either of us acted alone.”