Activists Condemn Gilead for Exhorbitant Price of Their New Hepatitis C Drug

For Immediate Release December 9, 2013
Contact: Lynda Dee 410-332-1170 or lyndamdee@aol.com

Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C

The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir), a once-daily, first- in-class nucleotide polymerase inhibitor approved by the U.S. Food and Drug Administration on December 6, 2013, for the treatment of chronic hepatitis C,including those co-infected with HIV. While FPC believes that all hepatitis C virus (HCV) drugs are priced too high, the coalition of HIV and viral hepatitis treatment activists is especially dismayed by the wholesale acquisition cost (WAC) of $84,000 for a 12-week course of Sovaldi™. For comparison purposes, the FPC notes the 12-week WAC for the recently approved NS3/4A protease inhibitor Olysio™ (simeprevir) is $66,360.

“Sovaldi™ is a very safe and highly effective drug that will significantly shorten HCV therapy and either reduce or eliminate the need for injected pegylated interferon,” explained FPC Co-Chair Lynda Dee. “However, this does not give Gilead unconscionable pricing carte blanche, particularly when considering that Sovaldi™ still needs to be combined with ribavirin for the treatment of HCV genotype 2 for 12 weeks or genotype 3 for 24 weeks.

Briefing at Congress: The Changing Face of HIV/AIDS in America

Briefing: 

 The Changing Face of HIV/ AIDS in America

September 18, 2013 

Briefing: 9:30-10:30 a.m.

Reception: 10:30-11 :30 a.m.

US Congress Capitol Visitors Center, Room SVC 212

Hosted by:

AIDS Community Research Initiative of America (ACRIA) 

Services and Advocacy for GLBT Elders (SAGE) 

National Hispanic Council on Aging

Once a Month HIV Medications - Cost Effectiveness

Long-acting antiretroviral (ARV) formulations, now in clinical development, could prolong survival in people with HIV, according to results of a modeling study [1]. But the benefit may hold true only in people with barriers to good adherence. Although long-acting antiretrovirals may not be cheap, the researchers determined they could be "a good value" when used mainly for poorly adherent patients.

ID Week: "The Clinical Role and Cost-effectiveness of Long-acting Antiretroviral Formulations" - Long-Acting ARV Formulations Could Improve Survival in People With Poor Adherence 

HPV vaccine wears off quickly in HIV-positive women

Women with HIV probably need a booster shot of HPV vaccine within 2 years to maintain efficacy, according to a Canadian study of quadrivalent HPV vaccine (Gardasil) in 136 HIV-positive women.

Antibody response to the vaccine is strong enough at 2 years to protect about 90% of HIV-negative women against HPV [human papillomavirus]. "But in our population, with approximately a year and a half of follow-up, that number decreased to about 63%. There’s a much more rapid decline in antibody levels" among HIV-positive women, "which suggests this population might in fact benefit from a booster," said lead investigator Erin Moses, R.N., a researcher at the Women’s Health Research Institute in Vancouver, B.C.

http://www.familypracticenews.com/news/infectious-diseases/single-article/hpv-vaccine-wears-off-quickly-in-hiv-positive-women/6c13159316dce4a302a07794cef74fa7.html

What Can We Look Forward to in HIV Cure Research? Conversation With Research Advocate Richard Jefferys

This past March, the 20th Conference on Retroviruses and Opportunistic Infections (CROI) brought an unprecedented flurry of mainstream interest in potential HIV cure strategies. TheBodyPRO.com's Nelson Vergel sat down with leading HIV cure research activist Richard Jefferys for an update on current important aspects, and controversies, in HIV cure research. Jefferys, who coordinates the Basic Science Vaccines and Prevention Project at Treatment Action Group in New York City, is at the forefront not only of gathering data and information from different studies, but also of educating other activists on the new language of immune-based therapies. Read Part One of this conversation.


Part Two Here

How HIV Providers Should Prepare for Obamacare

The Affordable Care Act: The name alone is enough to make the eyes of clinicians and patients alike glaze over. Yet the impact of the ACA (colloquially called Obamacare) has the potential to be massive when it comes to access to clinical care for HIV-infected people in the U.S. And with more ACA-related changes on the near horizon, the importance of staying informed has never been greater, particularly for health care providers who work in settings supported by Ryan White CARE Act funding.

To discuss the real-world effects of the ACA and offer guidance to HIV health care professionals, we spoke by phone with two leading experts: Michael Saag, M.D., a professor of medicine and the director of the Center for AIDS Research at the University of Alabama at Birmingham, as well as a former chair of the HIV Medicine Association; and Michael Wong, M.D., an associate professor of medicine at Harvard Medical School and the board chairman of HealthHIV, an education and advocacy organization for frontline care providers.

Read more

ViiV goes for gold: US premium pricing may threaten dolutegravir use in Europe

On 12 August 2013, the FDA approved dolutegravir in the US. i-Base reported the news with an article linked to previous clinical trial results that noted not only the potential advantages but also some of the cautions.  One of the concerns was how the price, which didn’t accompany the original company press statement, would be critical for whether dolutegravir finds a significant market. While pricing is complex, the first indications of where ViiV have set their new drug are not encouraging. Unfortunately, dolutegravir has been priced as a second- rather than first-line option, with a US Wholesale Acquisition Cost (WAC) price of $1175 per month for 30 tablets ($39 per day, $14,105 per year).  When used by someone with integrase resistance the dose increases to 50 mg twice a day, presumably doubling the cost.

Read more here

Monthly or Quarterly Injectable HIV Antiretrovirals Are Safe and Effective in Early Study

GSK744, an investigational integrase inhibitor, and TMC278 LA (a long-acting, injectable form of the NNRTI rilpivirine [Edurant]) both showed safety and efficacy when administered in once-monthly or once-quarterly doses, according to a study presented at IAS 2013. There were no drug-related serious adverse events and all adverse events were either mild or moderate.

The phase 1 study, conducted by GlaxoSmithKline and Janssen, assessed the safety, tolerability, and pharmacokinetics of GSK744 (when given intramuscularly or subcutaneously) in conjunction with TMC278 LA (injected intramuscularly). The researchers enrolled 47 HIV-uninfected individuals (17 female and 30 male) with a median age of 39.5. Thirty-five were white, 10 black, and two of another race.

More details

The Future of HIV Treatment is Here: Once-a-Month Injections to Replace Daily Oral Medications

A combination of antiretroviral drugs in long-acting nanosuspension formulations achieved adequate blood levels and appeared safe in HIV negative study volunteers, offering the potential for a maintenance or PrEP option that could be taken once monthly, researchers reported at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) this week in Kuala Lumpur.

While modern antiretroviral therapy is highly safe and effective, agents that could be administered less frequently would improve convenience for people with HIV. A long-acting option could prove especially attractive for maintenance therapy once viral load is suppressed, or for pre-exposure prophylaxis (PrEP) in HIV negative people.

Click here for more details

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

(Los Angeles, CA) -- The HIV gene medicines company Calimmune announced today that the first patient has begun treatment in a Phase I/II clinical trial designed to determine whether a pioneering genetic medicine approach can help to protect individuals infected with HIV from the effects of the virus. The study, “Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection,” utilizes a gene medicine called Cal-1, developed in the lab of Nobel Laureate Dr. David Baltimore and by Calimmune.

In the study, 12 HIV-positive participants will be infused with their own T cells and stem cells (hematopoietic stem cells, HSC), which have been modified to block the HIV receptor CCR5, and to prevent HIV fusion. The procedure is designed to prevent the virus from entering and damaging protected cells. The dual approach used in the study is designed to reduce the possibility that HIV can develop resistance to the procedure.

The goal of the study is to assess the safety, feasibility, and tolerability of Cal-1 in HIV- infected individuals who have previously been on highly active antiretroviral therapy (HAART) but are not currently taking any antiretroviral agent.  In addition to routine clinical and laboratory assessments to monitor general health and HIV infection, the study will monitor the presence of Cal-1 protected cells in various cell types in the blood and lymphoid tissue. Other analyses will monitor the safety of Cal-1. The first patient was treated in the study in late June. Data from this study are expected in 2015.

All participants in the study’s three arms will receive the Cal-1 gene transfer. Participants in two of the three study arms will also receive different doses of a preconditioning drug known as busulfan, which may make the therapy more effective.

“This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development,” said Calimmune Chief Executive Officer Louis Breton.  “We are optimistic that what we learn from this study may bring us closer to the day when a one-time treatment could provide an alternative to a lifetime of antiretroviral therapy.”

The study has been partially funded by the California Institute for Regenerative Medicine (CIRM).  The study will take place at clinical trial sites in Los Angeles and San Francisco, Calif., under the direction of Principal Investigators Ron Mitsayasu, M.D., of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research. For more information, visit www.clinicaltrials.gov.