Are we PREPPED for PrEP?

<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-ppGtWhbF1ElYP5k1wdSPoE4XGW1E2ovXtc9d2_cdgZ-PWGhXowjYIBT8g8R_inLTlGUJOxBLvcHNZTBJbAVjFQG2dAABdahsLO9C4gR1vHTX8F29Pmti4dIUv2qzUruyWsaF0C_AgTvK/s1600/aaron_erika.jpg" imageanchor="1" style="clear: right; cssfloat: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" mda="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-ppGtWhbF1ElYP5k1wdSPoE4XGW1E2ovXtc9d2_cdgZ-PWGhXowjYIBT8g8R_inLTlGUJOxBLvcHNZTBJbAVjFQG2dAABdahsLO9C4gR1vHTX8F29Pmti4dIUv2qzUruyWsaF0C_AgTvK/s1600/aaron_erika.jpg" /></a></div>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 <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1108524#t=article">here</a>. The FDA resport is <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm">here.</a> <br /><br />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.<br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjka_TONZgOdAnJyRCGh-kOUSMdCOCmTM9uELv0DZ2fNW1ejXNHzN1JSxP36cOAcKJfOW4IkPUaIaybdJcntfiMAoecufvflaWvVOaMg3nmY_uKldk0NI_ztn3ecSueJc4N8IsEJFGm7izh/s1600/truvada+chemical+structure.gif" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="176" mda="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjka_TONZgOdAnJyRCGh-kOUSMdCOCmTM9uELv0DZ2fNW1ejXNHzN1JSxP36cOAcKJfOW4IkPUaIaybdJcntfiMAoecufvflaWvVOaMg3nmY_uKldk0NI_ztn3ecSueJc4N8IsEJFGm7izh/s320/truvada+chemical+structure.gif" width="320" /></a></div>Here's a few important issues:<br />*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 <br />*HIV transmission in serodiscordant couples occurs outside of a couple in 25-30% of cases (Donnell 2010; Cohen 2011)<br />*Estimated cost of daily therapy is likely to be in excess of $10,000/year. <br />*Lifetime costs (2010 numbers) for HIV treatment is $379,668 (excluding reproductive health related issues)<br /><br />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?<br /><br />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."<br /><br />Perhaps next steps need to be more medical advances resulting in more medicines that decrease the cost of transmission preventing medicines?<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj0YJf7_lGFkn5VB8VpjXyk1a3Lg4uh6aA31qY6vNgyPtvwtZncRfA5Ho_DxQe-XeMF9MhTcxmH1Nl5UHDpukLB8hz-AmzOB02p2kvhDnBmoBcUfPW8zR6EpYaw0oi11cfXbPvDyHsPAGwb/s1600/numbergirlswomenhiv2008.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="213" mda="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj0YJf7_lGFkn5VB8VpjXyk1a3Lg4uh6aA31qY6vNgyPtvwtZncRfA5Ho_DxQe-XeMF9MhTcxmH1Nl5UHDpukLB8hz-AmzOB02p2kvhDnBmoBcUfPW8zR6EpYaw0oi11cfXbPvDyHsPAGwb/s320/numbergirlswomenhiv2008.png" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">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 <br /><br /></td></tr></tbody></table><span style="font-size: x-small;">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</span><br /><span style="font-size: x-small;"><br /></span><span style="font-size: x-small;">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</span><br /><br />Kaiser Foundation 2012 Fact Sheet on Women with HIV <a href="http://www.kff.org/hivaids/upload/6092-09.pdf">here</a><br /><br /><strong><em>Hot Off the Press</em></strong>  Aaron, E., Cohen D. Pre-exposure Prophylaxis for the Prevention of HIV<br /><br />Transmission to Women in the United States <span style="font-family: AdvPAC4D; font-size: x-small;"><span style="font-family: AdvPAC4D; font-size: x-small;">AIDS </span></span><span style="font-family: AdvPACF3; font-size: x-small;"><span style="font-family: AdvPACF3; font-size: x-small;">2012, </span></span><span style="font-family: AdvPAC4C; font-size: x-small;"><span style="font-family: AdvPAC4C; font-size: x-small;">26</span></span><i><span style="font-family: AdvTimes; font-size: x-small;"><span style="font-family: AdvTimes; font-size: x-small;">:</span></span></i><br /><span style="font-family: AdvPACF3; font-size: x-small;"><span style="font-family: AdvPACF3; font-size: x-small;">000–000</span></span>

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 me...

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Circumsicing Babies

<span style="font-size: large;">   The focus of this blog has included the application of research to real life and evaluating headlines that are in response to research.  In other words, the "truthiness" of those headlines.</span><br /><span style="font-size: large;">   The American Academy of Pediatrics confirmed its stance and recommendation for male infant circumcision today.  The rationale behind the recommendation is that there are lower rates of certain infections amongst males who have had the procedure.  The outcome that shows a greater difference between circumcised and uncircumcised boys is urinary tract infections.  UTI rate also seems to have the most evidence behind it- it has been studied the longest. Other outcomes that researchers associate with lack of circumcision are HIV, HPV, cancer, and sexually transmitted infections in general.  (associated  meaning the outcomes are higher in one group than the other)</span><br /><span style="font-size: large;">   If I had a male child I would have him circumcised, but not because I believe that it prevents sexually transmitted diseases.  I believe that it may reduce infections in general and to tell you the honest truth - my decision is also aesthetic.</span><br /><span style="font-size: large;">   This morning I heard someone make an argument for circumcision as an HIV prevention strategy using the results of the change in HIV rates in African men, living in African countries who are circumcised as adults.  The person who was using this evidence to support circumcision in infant American boys was challenged.  Can you see why?  How are these two groups similar?  They are not.  The results from the adult study in another country does not translate to these boys.  Even if it makes biological sense, you can't extrapolate to such a different context.</span><br /><span style="font-size: large;">   Another point made in the discussion was that the rate of circumcision in the UK is much lower than that in the USA and UK men HIV is lower in the UK.  This was countered by another who said that the number of new cases was much higher in the UK - or the rate vs the prevalence (chronically ill vs newly ill).  Again - the two groups are not the same and a comparison is suspect. (what else protects against HIV?  Maybe UK men have less sex?  Maybe many are HIV and undiagnosed?  Who knows, but you can't show cause and effect either way.)</span><br /><span style="font-size: large;">  My biggest issue however, is when any of them try to say that circumcision prevents the "disease in question" or that not being circumcised causes it.  The only way to claim that direct link is to have some boys circumsized and others not and then make sure that they are exposed to the same conditions and risks throughout their lives and see if one groups gets more diseases than the others.  That has not been done and it will not be done.</span><br /><span style="font-size: large;">   I imagine that instead, most of these studies are looking at the characteristics of men with a disease.  To determine what those characteristics are, they have to ask questions - either of the men, their physicians or their partners. Or some combination. Whether or not they have been circumcised is observable but the number of sexual partners, the use of condoms with partners, consistent or occasional use of condoms, the risk behaviors of the people the men have sex with... all of those things have to be considered and all of those things have certain biases.  For example, a person might not remember, might not know, or might not want to say.  But, what if boys who are not circumcised have different <i>kinds</i> of sexual partners/experiences on average than the circumcised boys/men do? With all of these things impacting the risk of getting sick, how can one say that circumcision is the determinant?  Maybe a question to ask is whether or not condoms are more or less protective based on circumcision status. </span><br /><span style="font-size: large;">    I am not at all speaking out against the procedure - just the use of studies to make a link between the penis status and the diseases.  I am especially suspect of the circumcision - HPV link.  </span><br /><span style="font-size: large;">   Today I heard someone say that HPV causes penile cancer (they were claiming that circumcision prevents HPV and thus can prevent penile cancer).   That got a reaction from me! I feel certain that if HPV caused a cancer in men Merck (drug company with the HPV vaccine) would be all over it.  Unless of course,  the association is real but the actual cancer incidence is extremely low. </span><br /><span style="font-size: large;">   I have not reviewed any of the studies, my main point is that there is a great deal to consider and just because someone says it on the radio, doesn't make it true.</span><br /><span style="font-size: large;">   Here is a link to <a href="http://pediatrics.aappublications.org/content/early/2012/08/22/peds.2012-1989.abstract" target="_blank">the actual statement</a> from the pediatric organization as published in their leading journal. </span>

Circumsicing Babies

   The focus of this blog has included the application of research to real life and evaluating headlines that are in response to research.  ...

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HIV Virus May Hide in Brain

<div>FRIDAY, Aug. 27 (HealthDay News) -- The brain can be a convenient hiding place for HIV, the virus that causes AIDS.<br />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.<br />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.<br />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.<br />"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."<br />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</div>

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 o...

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Anti-HIV gel is declared breakthrough for women

<div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEheYXpKlQ9uprNlNzFsaMvjQgn_S6KvpTPhkdpvpKn2RjUlquo8kJmMOBv_Sn83rgOnCNg_oPD7rTkEgUk2JnQC6ZjrkGGdgF1FiLOvopOU5aO5g7Vwga1JbpbTzgiD6oiUXj03928EJBpP/s1600/vaginal-gel-for-AIDS-300x199.jpg" imageanchor="1" style="clear: right; cssfloat: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" ox="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEheYXpKlQ9uprNlNzFsaMvjQgn_S6KvpTPhkdpvpKn2RjUlquo8kJmMOBv_Sn83rgOnCNg_oPD7rTkEgUk2JnQC6ZjrkGGdgF1FiLOvopOU5aO5g7Vwga1JbpbTzgiD6oiUXj03928EJBpP/s320/vaginal-gel-for-AIDS-300x199.jpg" /></a></div>By <a class="linkedBylineName" href="http://content.usatoday.com/topics/reporter/Steve+Sternberg">Steve Sternberg</a>, USA TODAY</div><br /><br /><div>Researchers say they've achieved the first AIDS prevention breakthrough for women.<br />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.<br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiEAFP_rMPgj3V61bt_mbj5scjr-8ov_53oBqhuQVdaAksUTmt5jUQcS4Md6vBwDuPWRy2iH0Lsn_kq_UJ0CwS6jOGtdJdBGP3KcFGaklcRgT4-DRQkFnSph0xIsgXRr1Qbk-4gydn3Lw6Q/s1600/200px-Tenofovir_disoproxil_fumarate.png" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="182px" ox="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiEAFP_rMPgj3V61bt_mbj5scjr-8ov_53oBqhuQVdaAksUTmt5jUQcS4Md6vBwDuPWRy2iH0Lsn_kq_UJ0CwS6jOGtdJdBGP3KcFGaklcRgT4-DRQkFnSph0xIsgXRr1Qbk-4gydn3Lw6Q/s200/200px-Tenofovir_disoproxil_fumarate.png" width="200px" /></a></div>The experimental gel is made with <a href="http://content.usatoday.com/topics/topic/Gilead+Sciences">Gilead Sciences</a>' 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.<br />The gel also reduced the risk of <a href="http://www.cdc.gov/std/herpes/stdfact-herpes.htm">genital herpes</a> by 51%, an unexpected bonus because <a href="http://www.webmd.com/genital-herpes/guide/risk-hiv">women with herpes are twice as likely to be infected with HIV.</a><br />"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 <a href="http://content.usatoday.com/topics/topic/Places,+Geography/Countries/South+Africa">South Africa</a>, who co-wrote the study with her husband and university colleague, Salim Abdool Karim.<br />At this level of protection, the researchers say, widespread use of the gel could prevent 1.3 million infections and more than 800,000 <a href="http://avert.org/worldstats.htm">deaths in South Africa</a> 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.<br />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.<br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQWt4CoOxfiIKiWztoPAPHTGsSRj4rRI0BcLlLwz9ukuinXt0EVD_cDB_9jGA_M8mVZmaysP8psKTBttoWe4hTVrMS_RIOyrGxjHHGFxnMswanQlQhN4d2-BfkRv8ni9HdM15b8mvzIZHQ/s1600/Yasmin-Halima-WEB.JPG" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="200px" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQWt4CoOxfiIKiWztoPAPHTGsSRj4rRI0BcLlLwz9ukuinXt0EVD_cDB_9jGA_M8mVZmaysP8psKTBttoWe4hTVrMS_RIOyrGxjHHGFxnMswanQlQhN4d2-BfkRv8ni9HdM15b8mvzIZHQ/s200/Yasmin-Halima-WEB.JPG" width="141px" /></a></div>"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."<br />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.<br />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.<br /><a href="http://www.niaid.nih.gov/about/directors/biography/Pages/biography.aspx">Anthony Fauci,</a> 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.<br />"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."<br />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.</div>Read more <a href="http://www.google.com/imgres?imgurl=http://www.knowabouthealth.com/wp-content/uploads/2010/07/vaginal-gel-for-AIDS.jpg&imgrefurl=http://www.knowabouthealth.com/breakthrough-microbicide-gel-protect-women-against-hiv/4272/&usg=__pdzo27dse3YJ8ZOLly2OQUiIbXI=&h=1129&w=1700&sz=20&hl=en&start=1&sig2=50NYee2yTM3Us2QtEuDCYA&zoom=1&um=1&itbs=1&tbnid=ja1bd9Lz8cH06M:&tbnh=100&tbnw=150&prev=/images%3Fq%3Dgel%26um%3D1%26hl%3Den%26rls%3Dcom.microsoft:en-us%26tbs%3Disch:1&ei=GGSKTN_nBIL-8AbfkbyxCg">here</a><br /><br /><em><b>Bloggers Note</b></em> - 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.<br /><br /><div></div><b><i>HIV terminology </i></b><br />HIV positive - evidence of exposure to HIV<br />AIDS - evidence of disease from HIV infection<br />ARVs antiretrovirals; <br /><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">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)      <i>  Click below to enlarge</i></div><div></div><br /><div><a href="http://www.usatoday.com/news/health/2010-07-19-anti-hiv-gel_N.htm"></a></div><table cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><br /> <tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi6SI0ZnQiufbhODIUfksEm1rvJ4J9rxFMdeX3L_yn2ZtP71tbdjXLeMZjXxIPn03Pya4UF1eAzu0g6mrLXLHi77zv6ORTmZHYii2bGxSL1iVj5j7JHZSCMnmmZ1y1-qRcKpnmmBqULKI3M/s1600/typeshivmeds.jpg" imageanchor="1" style="clear: right; cssfloat: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="300px" ox="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi6SI0ZnQiufbhODIUfksEm1rvJ4J9rxFMdeX3L_yn2ZtP71tbdjXLeMZjXxIPn03Pya4UF1eAzu0g6mrLXLHi77zv6ORTmZHYii2bGxSL1iVj5j7JHZSCMnmmZ1y1-qRcKpnmmBqULKI3M/s400/typeshivmeds.jpg" width="400px" /></a></td></tr><br /> <tr><td class="tr-caption" style="text-align: center;"><strong><a href="http://www.avert.org/treatment.htm">NRTIs, NNRTIs, PIs and Others</a></strong></td></tr><br /> </tbody></table>

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 ...

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