Are we PREPPED for PrEP?

PrEP is short for Pre-Exposure Prophylaxis of HIV to prevent transmission of disease. Recent studies have demonstrated that a combination medication tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) and the FDA has approved it's use.  Our own, Infectious Disease clinician, Erika Aarons, RN, CRNP, MSN was on the FDA Advisory panel that evaluated and voted upon approval of this new medication. Read the article here. The FDA resport is here.

This news is exciting in that this the first medication combination identified in 30 years that if taken regularly, can result in a 90% reduction in risk of an HIV negative partner acquiring the disease from their HIV positive partner. So, in serodiscordant partners (one with HIV/AIDs, one not) this is an incredible breakthrough.

Here's a few important issues:
*Medicine only was effective at that rate if taken every single day - those who did not have sufficient medication in their blood did not have the same result
*HIV transmission in serodiscordant couples occurs outside of a couple in 25-30% of cases (Donnell 2010; Cohen 2011)
*Estimated cost of daily therapy is likely to be in excess of $10,000/year.
*Lifetime costs (2010 numbers) for HIV treatment is $379,668 (excluding reproductive health related issues)

So PrEP is amazing scientifically, yet does it remain a wish versus a reality? This is a great example of the challenges faced when we address paying for prevention. I wonder how expensive or inexpensive an intervention would need to be to get support to prevent Diabetes?

HIV at the onset was (fairly) quick and (mostly) deadly disease - with the onset of HAART, HIV can become a chronic disease. At the beginning when there was only one or limited agents, medical science had not demonstrated how sneaky the HIV virus can be. It is now known that to combat disease, people often need three types of anti virals to keep the disease from changing and becoming resistant. I think of it as making a corral for a horse with three fences - keeping it within the triangle. If we use one or two or infrequently use the medicines, HIV learns quickly (becomes resistant) and makes the medicine ineffective.  Regular medicine use is challenged for any medical illness - HIV is no different. But there are some difference with HIV - CDC estimates that 1 in 5 people have disease and are unaware. So in place where there is a lot of HIV, people ages 11 and up and all people sexually active should have HIV screening as part of their routine evaluation. In the Philadelphia Ujima project, we talk about "Know Your Numbers, Own Your Health."

Perhaps next steps need to be more medical advances resulting in more medicines that decrease the cost of transmission preventing medicines?

Kaiser Family Foundation. www.statehealthfacts.org. Data Source: Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention-Surveillance and Epidemiology, Special Data Request; 2010

Donnell D, Baeten JM, Kiarie J, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010;375:2092-2098

Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505

Kaiser Foundation 2012 Fact Sheet on Women with HIV here

Hot Off the Press  Aaron, E., Cohen D. Pre-exposure Prophylaxis for the Prevention of HIV

Transmission to Women in the United States AIDS 2012, 26:
000–000

HIV Virus May Hide in Brain

FRIDAY, Aug. 27 (HealthDay News) -- The brain can be a convenient hiding place for HIV, the virus that causes AIDS.
That's the finding of Swedish researchers who analyzed samples from about 70 HIV-infected patients who'd been taking anti-HIV drugs. The tests showed that about 10 percent of the patients -- a larger proportion than expected -- had traces of HIV in their spinal fluid but not in their blood.
Another study by the researchers found that 60 percent of 15 HIV-infected patients treated with medication for several years showed signs of inflammation in their spinal fluid, although the levels were lower than they were without treatment.
Anti-HIV drugs can prevent the virus from multiplying, but the virus also infects the brain and can cause damage if the infection isn't treated, according to lead researcher Dr. Arvid Eden, a doctor and researcher at the Institute of Biomedicine at the Sahlgrenska Academy at the University of Gothenburg.
"Antiviral treatment in the brain is complicated by a number of factors, partly because it is surrounded by a protective barrier that affects how well medicines get in," Eden said in a university news release. "This means that the brain can act as a reservoir where treatment of the virus may be less effective."
It is unclear whether small quantities of the virus in spinal fluid represent a risk for future complications, researchers said. Still, the findings indicate that "we need to take into account the effects in the brain when developing new drugs and treatment strategies for HIV infection," Eden added

Anti-HIV gel is declared breakthrough for women

By Steve Sternberg, USA TODAY

Researchers say they've achieved the first AIDS prevention breakthrough for women.
More than a decade of failure and frustration ended Monday with a report that a new vaginal gel gives women the power to reduce their risk of contracting HIV and genital herpes without relying on their male partner to use a condom.

The experimental gel is made with Gilead Sciences' antiviral drug tenofovir, which is widely used for treating HIV, the virus that causes AIDS. Applying the 1% tenofovir gel 12 hours before and 12 hours after sex reduced a woman's risk of HIV infection by 39% over the course of 2½ years.
The gel also reduced the risk of genital herpes by 51%, an unexpected bonus because women with herpes are twice as likely to be infected with HIV.
"We now have a product that can potentially alter the epidemic and save millions of lives," says Quarraisha Abdool Karim of the University of KwaZulu-Natal in South Africa, who co-wrote the study with her husband and university colleague, Salim Abdool Karim.
At this level of protection, the researchers say, widespread use of the gel could prevent 1.3 million infections and more than 800,000 deaths in South Africa alone over the next 20 years. The findings were to be released today at the 18th International AIDS Conference in Vienna and in the online edition of Science.
AIDS researchers and advocates who have grown accustomed to failure, or worse — one promising vaginal gel actually was found to boost the risk of infection — hailed the report.

"This is good news," says Yasmin Halima, director of the Global Campaign for Microbicides, an advocacy group that has championed the approach. "Women are vulnerable to HIV across the world. Just having condoms for men is not really a viable option."
In the study, 889 sexually active women ages 18 to 40 were given either the tenofovir gel or a placebo. Thirty-eight of the women in the tenofovir group were infected with HIV, compared with 60 in the placebo group. Of 434 women who did not have herpes at the start of the trial, 29 of those using tenofovir became infected vs. 58 using a placebo.
The gel worked best in the women who used it most consistently. Women who used the gel at least 80% of the time were 54% less likely to become infected, cutting their risk of HIV by more than half.
Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, says the study marks a "significant conceptual advance" in efforts to give women the tools they need to protect themselves.
"The level of protection isn't as high as we hoped it would be," Fauci says, "but there are a lot of things we can do to change that. The degree of the effect was related to the degree (to which women used the gel.) You may want to use it more often. You may want to put it in a vaginal ring."
Halima noted that the pipeline of microbicides may include drug combinations similar to those now used for HIV treatment. Fauci says his institute is sponsoring a complex trial that compares patients using tenofovir gel daily with those taking oral tenofovir or Truvada, a combination of tenofovir and Emtriva, also made by Gilead Sciences. Results won't be available for at least a year, he says.

Read more here

Bloggers Note - Despite significant challenges in developing an immunization for HIV, this advance may be critical to saving lives for women.  Additionally, this success will stimulate industry and research for additional advances.

HIV terminology
HIV positive - evidence of exposure to HIV
AIDS - evidence of disease from HIV infection
ARVs antiretrovirals;

HAART Highly Active Anti-Retroviral Therapy (HAART) consists of 3 or more highly potent anti-HIV drugs (usually need three to 'contain' the virus and prevent development of resistance)        Click below to enlarge

NRTIs, NNRTIs, PIs and Others