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Gilead: Preventing HIV Infection With a Pill;
CDC Truvada Prevention Guidelines Forthcoming
 
 
  by Marie Daghlian
November 28, 2010
http://seekingalpha.com
 
"The CDC said Tuesday it would release guidelines for doctors on the use of the pill soon, given that the drug is already available. Truvada isn't approved by the Food and Drug Administration for use to prevent HIV, but physicians can prescribe any approved drugs as they see fit......It isn't clear whether Gilead will pursue permission to market the drug for HIV prevention. The answer is dependent on how the major stakeholders, public health agencies, community physicians, patient advocacy groups, FDA, and other regulatory agencies think of this," said Howard Jaffe, president of the Gilead Foundation, a charitable giving arm of Gilead Sciences, and a co-author on the paper. "We have not had those discussions yet. The researchers said side effects were mild in the study, whose duration for participants averaged 1.2 years. They plan an additional 18-month study, starting next year, to explore the drug's long-term effectiveness and safety, as well as risk behavior and pill-taking practices......The iPrEx study found that PrEP was more protective among those who reported taking the pill more regularly. Among participants who used the tablet on 50% or more of days, as measured by pill counts, bottle counts and self-reports, risk of HIV infection fell by 50.2% (95% CI 17.9-69.7%; P=0.006); among those who used the pill on 90% or more of days, as determined by the same measures, the PrEP pill reduced infection risk by 72.8% (95% CI 40.7-87.5%; P=0.001)......Side effects from use of the PrEP pill were mild and infrequent in the iPrEx study. These included a small number of reports of low-grade transient nausea, which dissipated after several weeks. Such symptoms are relatively common after initiation antiretroviral therapy, and reassurance from peers and providers in the first few weeks is important to promote long term adherence. In addition, isolated mild elevations of creatinine, a naturally occurring molecule filtered by the kidneys, occurred in a small number of individuals receiving the active drug and resolved spontaneously or with discontinuation of the pill. Slight increases were also detected in headache and unintentional weight loss among participants in the study arm that received FTC/TDF. The iPrEx study carefully monitored for any indications of HIV drug resistance among individuals who became HIV infected during the study. No iPrEx study participant developed detectable resistance to tenofovir (TDF), one of the component drugs of the PrEP pill used in this study. Two participants who received the active PrEP drug developed resistance to the its other component drug, emtricitabine (FTC), and one participant who received placebo appears to have been infected with a strain of HIV that was already resistant to FTC. All three participants with FTC resistance were HIV-infected at the time of enrollment in iPrEx, but their infection was too new to be detected by standard HIV antibody testing. Investigators emphasize the need for additional testing and clinical screening to ensure that anyone starting PrEP is not already HIV infected."
 
Just 25 years ago, HIV-AIDS was a death sentence for anyone who contracted the disease. Although it can now be controlled by antiretroviral therapies, preventing infection has not been very effective as an estimated 2.7 million people contract the disease each year. Now, a major study has demonstrated that Gilead's (GILD) combination pill Truvada can protect high-risk men without the disease from becoming infected with HIV.
 
The study shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir, which are marketed by Gilead as Truveda, experienced an average of 44 percent fewer HIV infections than those who received a placebo pill. Results, reported in the New England Journal of Medicine, are the first evidence that this new prevention method-pre-exposure prophylaxis or PrEP-reduces HIV infection risk in people.
 
"We now have strong evidence that pre-exposure prophylaxis with an antiretroviral drug can reduce the risk of HIV acquisition among men who have sex with men, a segment of the population disproportionately affected by HIV/AIDS," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "Additional research is needed, but certainly this is an important finding that provides the basis for further investigating, developing and employing this prevention strategy, which has the potential to make a significant impact in the fight against HIV/AIDS."
 
Led by study chair Robert Grant of the Gladstone Institute of Virology and Immunology, and study co-chair Javier Lama of Investigaciones Medicas en Salud, a Peruvian-based research organization, the study enrolled a total of 2,499 men and transgender women who have sex with men, who were HIV-negative at the time of enrollment but were at high risk for HIV infection, at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand and the United States.
 
All study participants received a comprehensive package of prevention services designed to reduce their risk of HIV infection throughout the trial, including HIV testing, intensive safer sex counseling, condoms and treatment and care for sexually transmitted infections. Half of study participants also received the PrEP pill, while the other half received a placebo.
 
In all, 64 HIV infections were recorded among the 1,248 study participants who received a placebo pill, while 36 HIV infections were recorded among the 1,251 participants who received the study drug. The average reduction in HIV infection risk of 44 percent includes all study participants-even those who did not take the daily pill consistently.
 
The study found that PrEP was more protective among those who reported taking the pill more regularly. Among participants who used the tablet on 50 percent or more of days, as measured by pill counts, bottle counts and self-reports, risk of HIV infection fell by 50 percent; among those who used the pill on 90 percent or more of days, as determined by the same measures, the PrEP pill reduced infection risk by 73 percent.
 
Side effects from use of the PrEP pill were mild and infrequent in the study. Researchers will continue to collect and analyze data on low level side effects related to bone mineral density or kidney function, which have been associated with some HIV therapies. Two study participants who received the active drug developed resistance to the emtricitabine component. Use of the PrEP pill did not cause study participants to relax their use of safer sex practices. In fact, self-reported HIV risk behavior decreased among participants in both arms of the study, and condom use increased.
 
Other studies of PrEP are currently underway among heterosexual men and women, serodiscordant couples and injection drug users. Researchers are careful to point out that those trials should continue, as results from this study cannot be extrapolated to predict the impact of PrEP on other populations. Approximately 20,000 participants are currently or expected to be enrolled in PrEP trials worldwide. PrEP was previously demonstrated to be highly effective in animal studies.
 
"A variety of expert and community advisory groups at the federal, state and local levels are looking closely at the study data and will move forward in a deliberative and measured way over the coming months to determine whether and how these findings should be incorporated into ongoing HIV prevention programs," says Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services.
 
Investigators will conduct a follow-on study in which all HIV-negative study participants will be offered the combination drug for 18 months. That study, which will begin in 2011, is designed to provide additional information about the drug's long-term effectiveness and safety as well as participant risk behavior and pill-taking practices.
 
The National Institute of Health cautions that correct and consistent condom use and a reduced number of sexual partners remain the most effective ways for gay and bisexual men to protect against HIV infection.
 
Disclosure: No positions
 
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Gilead said it was encouraged by this new evidence that Truvada could reduce the risk of acquiring HIV, and that it will work with the appropriate regulatory agencies moving forward.
 
"I still am just completely perplexed at the enthusiasm for this when there are, again, 10 to 15 MILLION people who are living with HIV who need ARV now. Seems to me, further lowering community viral load is a far more sensible prevention strategy along with the usual efforts to do outreatch, counseling, needle and condom access, etc."
 
Truvada costs $5,000 to $14,000 a year in the US and it's not yet clear if government funding would be available for any new indication, and is available generically in many countries at prices as low as approximately 40 cents (U.S.) per tablet in the poorest countries of the world.. The costs of post-infection treatment will be something for the FDA to consider in light of pre-exposure prescription.
 
The Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organisation (WHO) also welcomed the research.
 
Dr Margaret Chan, WHO director general, said: "We look forward to further examining these data to consider how we can best use this tool to enhance HIV prevention when used in combination with other prevention such as condom promotion in this population at higher risk."
 
The research included 2,499 men from six countries. Its findings compliment those from a study released earlier this year that found a vaginal microbicide gel containing tenofovir used before and after sex to be 39% effective in preventing new HIV infections in women.
 
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Daily Pill Slashes Risk of HIV Infection in Study
 
http://online.wsj.com
NOVEMBER 23, 2010
 
By BETSY MCKAY And AMY DOCKSER MARCUS
 
A study released Tuesday shows an existing antiretroviral drug can also ward off HIV infections in what researchers call a major advance in the quest to find medicines that prevent rather than simply treat AIDS.
 
The study of nearly 2,500 gay and bisexual men on four continents follows two other recent breakthroughs in AIDS-prevention research after years of frustration and as the cost of treating HIV/AIDS globally continues to rise, with about 2.7 million new HIV infections every year.
 
Results of one clinical trial in 2009 showed that an AIDS vaccine offered partial protection, while another study released in July demonstrated that a vaginal gel containing an antiretroviral drug cut the risk of HIV infection for women.
 

The drug is known by the brand name Truvada and made by Gilead Sciences. Associated Press
 
In the latest study, published online in the New England Journal of Medicine, gay and bisexual men who took the drug in pill form were 44% less likely to become infected than a control group taking a placebo.
 
Both groups received counseling to use condoms, but comparable numbers of men in both groups ignored the advice.
 
Men who reported taking the drug every day, as directed, had a 73% lower risk of infection.
 
The findings "represent a major advance in HIV research," said Kevin Fenton, the Centers for Disease Control and Prevention's HIV/AIDS chief. In a statement, President Barack Obama said such studies "could mark the beginning of a new era in HIV prevention."
 
Gay and bisexual men make up about 48% of the more than one million people the CDC estimates are infected with HIV in the U.S. The agency says the rate of new HIV diagnoses among that group is more than 44 times that of other men and more than 40 times that of women.
 
The results also point to multiple challenges in wide use of the pill, a drug combination known by the brand name Truvada and made by Gilead Sciences Inc. Antiretrovirals work by inhibiting an enzyme the virus uses to replicate its genetic material.
 
Many of the participants didn't adhere to the daily drug regimen, raising questions about how easy it will be to get men at high risk of infection-outside the setting of a clinical trial-to take the drug as they should. "The trial is a biological success and a behavioral challenge," said Mitchell Warren, executive director of AVAC, a group that tracks andpromotes AIDS-prevention research.
 
The drug is widely available in several countries, including the U.S., creating the potential for misuse by people to whom the findings don't apply.
 
----------------------------------
 
Decades of Progress and Setbacks
 
Recent advances have followed years of frustration on HIV prevention.
 
1981:First reported cases of disease that would become known as AIDS discovered in five homosexual men in Los Angeles
 
1987:First antiretroviral, AZT, approved for treating AIDS
 
1989:Number of AIDS cases reported in U.S. reaches 100,000
 
1994:AZT shown to reduce risk of mother-to-child transmission of HIV
 
1995-96:First protease inhibitors approved by FDA, ushering in use of drug cocktails
 
1998:First major trial of AIDS vaccine candidate begins
 
2003:Vaccine candidate found ineffective
 
2007:Another major HIV vaccine trial halted, shows no benefit
 
2008:Estimated 33 million people world-wide living with virus
 
2009:In July, a study finds that women who apply gel containing the drug tenofovir before and after sex reduce chance of HIV infection. In September, an HIV vaccine in a test in Thailand with 16,000 patients is found 31% effective in preventing infection.
 
2010:Clinical trial finds that once daily oral retroviral tablet reduces risk of HIV infection among men who have sex with men and transgender women who have sex with men.
 
Source: Avert and UNAIDS
 
---------------------
 
Public-health officials also are concerned that gay and bisexual men on the drug might forgo condoms or other prevention measures. In the study, the risk of HIV infection was reduced only 21% in men whose adherence to the drug regimen was less than 90%. The men in the study didn't abandon other prevention measures, however.
 
"Many people won't want to take an antiretroviral every day," said Chris Collins, vice president and director of public policy at amfAR, the Foundation for AIDS Research.
 
Other studies are under way to determine whether antiretroviral drugs can offer similar protection to injection-drug users and heterosexuals.
 
Scientists say it isn't clear whether the drug will work for all groups at high risk of infection because the virus enters the body in different ways in each case.
 
"It's not time for men to throw out their condoms," Dr. Fenton said, adding that it is "unlikely this will be a large part" of the U.S. prevention strategy for the CDC in the short term. The agency focuses on promoting HIV testing, screening for sexually transmitted diseases and other measures.
 
The CDC said Tuesday it would release guidelines for doctors on the use of the pill soon, given that the drug is already available. Truvada isn't approved by the Food and Drug Administration for use to prevent HIV, but physicians can prescribe any approved drugs as they see fit.
 
Another question is who will pay for the drug. The wholesale cost of Truvada in the U.S. is $995.96 per month, for a bottle of 30 tablets, and it costs as little as about $12 a month in some developing countries, according to Gilead.
 
It isn't clear whether Gilead will pursue permission to market the drug for HIV prevention.
 
"The answer is dependent on how the major stakeholders, public health agencies, community physicians, patient advocacy groups, FDA, and other regulatory agencies think of this," said Howard Jaffe, president of the Gilead Foundation, a charitable giving arm of Gilead Sciences, and a co-author on the paper. "We have not had those discussions yet."
 
The researchers said side effects were mild in the study, whose duration for participants averaged 1.2 years. They plan an additional 18-month study, starting next year, to explore the drug's long-term effectiveness and safety, as well as risk behavior and pill-taking practices.

 
Write to Betsy McKay at betsy.mckay@wsj.com and Amy Dockser Marcus at amy.marcus@wsj.com
 
---------------------------------------
 
Study Press Release
 
Use of HIV medications reduces risk of HIV infection in uninfected people

 
Submitted by editor on November 28, 2010 - 11:30
 
(San Francisco, CA) - In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill (95% CI 15.4 to 62.6%; P=0.005). The study, reported in the New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.
 
A total of 2,499 individuals at high risk of HIV infection participated in the six-country iPrEx study. All study participants received a comprehensive package of prevention services designed to reduce their risk of HIV infection throughout the trial, including HIV testing, intensive safer sex counseling, condoms and treatment and care for sexually transmitted infections. Half of study participants also received the PrEP pill, while the other half received a placebo.
 
In all, 64 HIV infections were recorded among the 1,248 study participants who received a placebo pill, while 36 HIV infections were recorded among the 1,251 participants who received the study drug. The average reduction in HIV infection risk of 43.8% includes all study participants - even those who did not take the daily pill consistently.
 
The iPrEx study found that PrEP was more protective among those who reported taking the pill more regularly. Among participants who used the tablet on 50% or more of days, as measured by pill counts, bottle counts and self-reports, risk of HIV infection fell by 50.2% (95% CI 17.9-69.7%; P=0.006); among those who used the pill on 90% or more of days, as determined by the same measures, the PrEP pill reduced infection risk by 72.8% (95% CI 40.7-87.5%; P=0.001).
 
While pill-taking measures that rely on self-reports are not objective, testing to measure levels of the PrEP drug in the blood of study participants -- a more reliable measure of pill-taking -- also indicated that those participants who were protected against HIV infection were likely taking the study drug more regularly. Among a subset of study participants who received the active drug, detectable levels of the PrEP drug combination were found in the blood of 51% (22 of 43) of a group that remained HIV-negative, but in only 9% (3 of 34) of participants who became HIV infected. Low or absent drug levels underlay all of the infections that occurred among those who received active PrEP, while those who used the drug more regularly had higher levels of protection against HIV infection.
 
The iPrEx study proves that PrEP provides important additional protection against HIV when offered with other prevention methods such as HIV testing, counseling, condom use and management of sexually transmitted infections, said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. As with other prevention methods, the greatest protection comes with consistent use. I hope this finding inspires a renewed commitment from communities, industry and government to stop the spread of HIV.
 
iPrEx is a significant advance in HIV prevention, said Javier R. Lama, MD, MPH, the co-chair of the study protocol who is based in Lima, Peru. Thanks to the extraordinary efforts of our study participants, their families and communities, iPrEx shows that a preventive drug can significantly reduce HIV infection risk. Further research is now needed to optimize the efficacy of oral PrEP based on iPrEx results.
 
About iPrEx and PrEP
 
The iPrEx study (Iniciativa Profilaxis Preexposicion or Prexposure Prophylaxis Initiative)
 
(http://www.iprexnews.com), is a double-blind, placebo controlled Phase III clinical trial that began in 2007 following three years of community consultation. iPrEx is the first human efficacy study of PrEP to report data. The iPrEx study was sponsored by the U.S. National Institutes of Health (NIH) through a grant to the Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco. Additional support for iPrEx was provided by the Bill & Melinda Gates Foundation.
 
The devastating impact of HIV continues to spread around the world, said R. Sanders Williams, M.D., president of the Gladstone Institutes, which coordinated the iPrEx study. Gladstone will continue its research into new ways to prevent HIV infection, and we urge community organizations and governments to make available effective scientific advances to stop HIV such as PrEP.
 
In all, 2,499 men and transgender women who have sex with men (MSM) at high risk for HIV infection participated in the iPrEx study at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand and the United States. Other studies of PrEP are currently underway among heterosexual men and women, serodiscordant couples and injection drug users. iPrEx researchers are careful to point out that those trials should continue, as results from the iPrEx study cannot be extrapolated to predict the impact of PrEP on other populations. Approximately 20,000 participants are currently or expected to be enrolled in PrEP trials worldwide. PrEP was previously demonstrated to be highly effective in animal studies.
 
In July, 2010, a study known as CAPRISA 004 found evidence that a topical gel containing 1% tenofovir helped reduce HIV negative womens risk of HIV infection via vaginal sex. The topical gel is another form of HIV prevention using antiretroviral drugs currently being explored, in addition to oral PrEP.
 
The drug used in the iPrEx study, a single-tablet combination of emtricitabine (FTC 200 mg) and tenofovir (TDF 300 mg), is marketed by Gilead Sciences, Inc. under the brand name Truvada®, and is available generically in many countries at prices as low as approximately 40 cents (U.S.) per tablet in the poorest countries of the world. Gilead Sciences provided study drug for, but did not participate in any other way in the design, implementation or analysis of the iPrEx study.
 
National and international health authorities and regulatory bodies must now meet to review the iPrEx study data and to determine whether and how to recommend use of PrEP for people at increased risk of HIV infection. Much remains to be learned about how to maximize the impact of PrEP and use this new tool most effectively. An 18-month open label study of FTC/TDF PrEP, which will provide the drug to HIV uninfected participants in the original study who wish to join, will begin next year and should provide additional information on efficacy, safety, behavior and pill taking. HIV-positive iPrEx participants will also be invited to enroll in this phase of the study for ongoing monitoring.
 
The impact of HIV on MSM
 
iPrEx studied the impact of PrEP on one of the populations hardest hit by the global HIV epidemic, men and transgender women who have sex with men (MSM). Globally, even in regions with generalized HIV epidemics such as Africa and Asia, MSM often have much higher rates of HIV infection than the population at large. HIV prevention tools that reduce infection in MSM not only have the potential to save thousands or millions of lives directly, but could also greatly reduce the impact of HIV on all communities at risk by reducing overall prevalence of the disease and thus the global risk of HIV infection.
 
iPrEx is one of the largest HIV prevention clinical trials to focus on men who have sex with men, the first HIV prevention study to focus on MSM to be conducted in either Africa or Asia, and the first demonstration of a biomedical intervention to prevent HIV infection in MSM.
 
Side effects, resistance and behavioral issues in iPrEx
 
Side effects from use of the PrEP pill were mild and infrequent in the iPrEx study. These included a small number of reports of low-grade transient nausea, which dissipated after several weeks. Such symptoms are relatively common after initiation antiretroviral therapy, and reassurance from peers and providers in the first few weeks is important to promote long term adherence. In addition, isolated mild elevations of creatinine, a naturally occurring molecule filtered by the kidneys, occurred in a small number of individuals receiving the active drug and resolved spontaneously or with discontinuation of the pill. Slight increases were also detected in headache and unintentional weight loss among participants in the study arm that received FTC/TDF.
 
The iPrEx study carefully monitored for any indications of HIV drug resistance among individuals who became HIV infected during the study. No iPrEx study participant developed detectable resistance to tenofovir (TDF), one of the component drugs of the PrEP pill used in this study. Two participants who received the active PrEP drug developed resistance to the its other component drug, emtricitabine (FTC), and one participant who received placebo appears to have been infected with a strain of HIV that was already resistant to FTC. All three participants with FTC resistance were HIV-infected at the time of enrollment in iPrEx, but their infection was too new to be detected by standard HIV antibody testing. Investigators emphasize the need for additional testing and clinical screening to ensure that anyone starting PrEP is not already HIV infected.
 
A concern that the use of the PrEP pill could cause study participants to relax their use of safer sex practices was not demonstrated in the iPrEx study. In fact, self-reported HIV risk behavior decreased among participants in both arms of the study, and condom use increased. More research is needed to see how risk behavior may change now that information is available about PrEP safety and efficacy.
 
Additional data from the iPrEx study will be collected, analyzed and released in the coming year. This will include analyses designed to detect any low level side effects related to bone mineral density or kidney function, which have been associated with some HIV therapies. Other analyses will search for any additional evidence of drug resistance, look for evidence of use of the PrEP tablet through measures of drug exposure and will examine HIV risk behavior through the occurrence of sexually transmitted infections.
 
Every year 2.7 million people are infected with HIV, and PrEP has the potential to help bring those numbers down. We have a moral obligation and a public health imperative to quickly act on these results. The HIV prevention field and national HIV policymaking bodies, along with WHO and UNAIDS, must promptly review the iPrEx data, consult with both experts and affected communities and develop clear plans and recommendations for next steps in research and possible access to PrEP, said Mitchell Warren, executive director of AVAC, a global HIV prevention advocacy organization.
 
###
 
Additional information about the iPrEx study and PrEP:
 
Manuscript: http://www.nejm.org/doi/full/10.1056/NEJMoa1011205
 
iPrEx Study FAQ and fact sheets: http://www.iprexnews.com
 
iPrEx study materials from the National Institutes of Health (NIH):
 
Release: http://www.niaid.nih.gov/news/newsreleases/2010/Pages/iPrEx.aspx
 
Q&A: http://www.niaid.nih.gov/news/QA/Pages/iPrExQA.aspx
 
Additional information on PrEP from Global Advocacy for AIDS Prevention (AVAC): http://www.avac.org/ht/d/sp/i/262/pid/262/cat_id/458/cids/453,458
 
Information on the iPrEx study drug, FTC/TDF: http://www.truvada.com/
 
About the Gladstone Institutes
 
Gladstone is an independent, nonprofit biomedical research organization dedicated to accelerating the pace of scientific discovery and biomedical innovation to prevent illness and cure patients suffering from cardiovascular disease, neurodegenerative disease or viral infections. Gladstone is affiliated with the University of California, San Francisco. More information can be found at www.gladstone.ucsf.edu.
 
Information Source: EurekAlert!
 
-----------------------------------------
 
A Massive HIV Breakthrough, Ctd
 
26 Nov 2010 10:39 am
http://andrewsullivan.theatlantic.com
 
A reader writes:
 
I'm a loyal reader and a grad student in public health with an interest in HIV/AIDS, so your posts on Truvada prophylaxis caught my attention. Good news? Yes. Breakthrough? Not so fast. First off, the 44 percent figure is the important one - not 90 percent - because what really matters is how well the drug works in real life. That a large percentage of the participants in this study still didn't take the pills regularly despite having better-than-average medical attention is a serious problem. Also, all study participants received HIV testing, safe sex counseling, condoms, and treatment for STIs during the study. Who knows whether the effect would be as strong with people not receiving all those other protective services - could be higher or lower.
 
But the biggest red flag to me is behavioral disinhibition, the idea that people act differently when they believe their risk is lower.
 
A benefit from a 44 percent decrease in infections could quite easily be eliminated by changes in sexual behavior that would result from the knowledge that you're "protected." That's also a huge worry re: male circumcision, which is being pushed in sub-Saharan Africa right now. Studies suggest that circumcision does have a protective effect, but it remains to be seen whether that will hold true on a population scale when men believe it protects them and thus may change their behavior. The circumcision studies, like the Truvada study, were all done with intensive counseling (for ethical reasons) which makes the results far less generalizable. The way circumcision is being pushed in areas with high HIV prevalence is, to me, a quite frightening population-wide experiment, because we just don't know yet whether it will help or hurt.
 
Yes, the Truvada study is big news, but we'll need a lot more data before we'll know if it's really a breakthrough.
 
All of this is perfectly true, for the population as a whole. We will indeed see if this good news is a breakthrough. But compliance with drug regimens is always an issue - and a single pill is arguably the simplest, easiest regimen to follow. Perhaps, taking a pill to prevent infection rather than treat it makes it more likely to be missed or followed intermittently - but even then, the danger of failure is much less than with highly complex, multi-drug post-infection regimens.
 
The core point for me is that if one person diligently takes this drug and has a sex life, he or she is far, far less likely ever to become infected. We have never been able to say that in the three decades we have lived with this disease in America. That's why it's a breakthrough. And given the success of complex drug regimens in Africa and in poor, urban America, I see no reason not to be optimistic about a simple prophylaxis like this - especially for women who cannot get their lovers to wear a condom.
 
 
 
 
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