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Posts Tagged ‘AIDS

Expedited Drug Approvals: When Speeding Saves Lives

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By: Maria Disotaur, PhD

Source: piqsels.com

Changes in laws and regulations have accelerated the drug approval process for rare and fatal diseases. Yet, some experts worry the process is now moving too fast, while others argue that slowing down the process could cost patients their lives. 

The first case of acquired immunodeficiency syndrome (AIDS) in the United States was reported in 1981. Ten years later, more than 250,000 Americans were living with the disease or had died from the epidemic. During this time, activist groups believed the drug approval process was unacceptably slow and possibly leading to the deaths of thousands of Americans. They demanded drugs be proven safe and effective at a faster rate because prior to 1992, the Food and Drug Administration’s (FDA) drug approval process could take two and a half to 8 years due to poor staffing and lack of resources within the agency. Protests at the FDA headquarters, led to the establishment of streamlined policies and regulations designed to speed the approval process for life-saving drugs for serious and often fatal diseases. 

In 1992, a series of complex regulations and processes were established to place life-saving drugs in the hands of patients as expeditiously as possible. Beginning with the Prescription Drug User Fee Act (PDUFA), the agency could charge pharmaceutical companies a $200,000 reviewer fee for a new drug approval application (NDA). This new policy increased agency funds, personnel, and reduced the amount of time to approve a new drug to approximately eighteen months. To further expedite the process the agency introduced accelerated approval and priority review. The former allowed the FDA to use a surrogate endpoint to approve a new drug for a serious medical condition with an unmet medical need. Priority review, required the FDA to review a drug within six months compared to the standard ten months, if the drug showed evidence of significant improvement in treatment, diagnosis, or prevention. These were followed by fast track designation in 1998 and breakthrough therapy designation in 2012, which were designed to expedite the development and review of life-saving drugs that, respectively, fulfilled an unmet need or were better than current market drugs. 

Since their introduction, these regulations have garnered two opposing groups: those that think the drug approval process is moving too fast and those that think it is not moving fast enough. Pharmaceutical companies, health professionals, and patient advocacy groups have argued that millions of Americans are suffering from rare and orphan diseases that require new or enhanced therapies. On the other hand, experts argue that the pathway to expedite drug approvals does not change the fundamental principles of testing the efficacy of a new drug through extensive preclinical research and clinical trials. A recent study published in the Journal of the American Medical Association (JAMA) points to some of the downfalls associated with the FDA’s accelerated approval process. The study looked at 93 cancer drugs approved by the FDA from 1992 to 2017 through the accelerated approval pathway and analyzed the results of confirmatory trials, which are phase 4 post-marketing trials required by the FDA to confirm the clinical benefit of a drug. The study showed that out of the 93 cancer drugs approved only 19 drugs had confirmatory trials that reported an improvement in the overall survival of patients. The study authors concluded that “it is important to recognize the clinical and scientific trade-offs of this approach” particularly since “the clinical community will have less information about the risks and benefits of drugs approved via the accelerated approval program” until confirmatory trials are completed to analyze the clinical benefit and survival for patients. Furthermore, others like Dr. Michael Carome, a physician and a director at the consumer advocacy group Public Citizen, have raised concerns about the medical value and cost of drugs that have limited scientific data. Particularly, the burden placed on families and patients for drugs that in some instances, or in the case of the article published by JAMA, 80% of instances, never prove effective and do not improve patient survival. This was the case for Eli Lilly’s drug Lartruvo, as reported by the Wall Street Journal last summer. In 2016, Lartruvo became the first drug approved by the FDA for soft-tissue sarcoma since the 1970’s. The drug was approved via the accelerated approval pathway after Elli Lilly completed a study with 133 patients showing that Lartruvo with chemotherapy treatment extended the median patient survival by 11.8 months compared to patients using chemotherapy alone. By April 2019, Elli Lilly announced it was removing Lartruvo from the market because in Phase 3 clinical trials, it did not show improvement in patient survival. The removal of Lartruvo from the market left patients dismayed and questioning the long-term effects of the treatment. Prior to Lartruvo’s approval, Dr. James Liebman, an oncologist from Beverly Hospital, and Dr. Hussein Tawbi, an associate professor at MD Anderson Cancer Center expressed concerns about the limited sample size and confounding results for Lartruvo and recommended the FDA delay the approval until other trials were conducted. At the time, the FDA acknowledged their concerns but also acknowledged that the treatments for advanced sarcoma were limited and that the drug could have a clinical benefit on the market. 

These critical decisions are becoming more routine as the FDA tries to meet the demands of doctors, patients, and lawmakers to approve drugs for fatal diseases at a faster rate. In 2009, only 10 drugs were approved through an expedited pathway – either fast-track, priority review, accelerated approval, or breakthrough therapy. Last year, this number increased to 43 drugs out of the 59 novel drugs approved. This jump can be partially accredited to the 21st Century Cures Act, which is designed to expedite the development of new devices and drugs and in some instances, the act allows the FDA to review anecdotal evidence such as patients’ perspectives when reviewing a new drug. Additionally, the increase can be attributed to new biological and diagnostic tools. For example, the use of flow cytometry and next generation DNA sequencing, which allows scientists to detect one cancer cell in a million healthy cells as reported by Scientific American last month. This new measure is called minimal residual disease (MRD) and scientists hope it can be used to accelerate clinical trials and the development of novel drugs. Currently, studies looking at B-cell acute lymphoblastic leukemia indicate MRD-positive patients are more likely to relapse and patients with more than 1 residual cancer cell in 10,000 cells lived approximately six months without relapse, while those that had less than 1 residual cancer cell in 10,000 lived an average of two years without relapse. Scientists hope this method can be used as a future surrogate endpoint and some patient advocacy groups believe that for some cancers like multiple myeloma there is enough evidence to use the method today. A study published in JAMA showed that multiple myeloma patients who were MRD-negative had reduced remission rates and had a 50% longer survival outcomes than those who were MRD-positive. The predictors of MRD indicate that for certain cancers scientists could use this as an alternative surrogate endpoint – it could speed up clinical trials compared to those that look at tumor shrinkage and overall survival. These types of new tools and diagnostics have been prompting patients and doctors to demand faster drug approvals, particularly for rare and life-threatening diseases. Furthermore, they have also compelled FDA officials and leaders like Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, to acknowledge that new scientific tools and advancements will continue to speed up the drug approval process. Concurrently, the agency understands the demands of patients living with life-threatening illnesses and is preparing to enhance its best practices. In a recent-press release, the FDA announced it would begin the “reorganization of the office of new drugs with corresponding changes to the office of translational sciences and the office of pharmaceutical quality.” This strategic move aims to “create offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise”. The goal is to enhance efficiency and provide FDA scientists with a better understanding of diseases that may require future FDA drug approval. These types of changes within the FDA infrastructure, along with biological advancements, will continue to impact the speed at which the FDA approves new drugs. Some individuals will argue that accelerating the process is reckless and a danger to vulnerable patients; however, for some of these patients accelerating the process can be the difference between life and death. For these patients, the question of expediting access to new treatments is not “Are we moving too fast?” it is “Can we afford not to?”

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January 17, 2020 at 6:48 pm

Science Policy Around the Web November 8th, 2019

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By Mary Weston PhD

Image by PublicDomainPictures from Pixabay 

Scrubbing Your House Of Bacteria Could Clear The Way For Fungus

While it may seem that a ‘cleaner’ environment would mean fewer germs, a new study in Nature Microbiology suggests otherwise. Researchers comparing the diversity of microorganisms in increasingly urbanized environments found that fungal diversity was actually higher in urban homes. They examined four types of housing, ranging from thatched huts in a Peruvian rainforest community to city apartments in Manaus, the capital of the Brazilian state of Amazonas. 

One of the study’s coauthors, Dr. Laura-Isobel McCall, suggests several reasons for why this may occur. Many antibacterial cleaning products specifically target bacteria, which could free space for fungi and other microorganisms to grow. Fungi have thicker cell walls, which may make them more difficult to destroy. Also, urban homes tend to block light and trap CO2, which could be creating a favorable setting for fungi to grow. 

In general, these results indicate that urbanization has large effects on the human skin microbiota, as well as the surrounding chemical and microbial environment. This lack of bacterial diversity could be problematic, as some of them may be helpful to humans. The researchers also discovered many more synthetic chemicals in city apartments, which can originate from cleaning products, building materials, medications, and personal care products (such as shampoo and deodorant). The effects of increased exposure to synthetic chemicals are not well known.

While this study was conducted in areas of Brazil and Peru, the findings may have a broader significance. Justin Sonnenber, a microbiologist at Stanford University, asserts that “My guess is that this gradient they’ve established for these fungal communities is largely representative of what’s happening all over the world”.  

(Pien Huang, NPR)

Trump administration sues HIV prevention drug maker for patent infringement

On November 6, the Trump administration sued Gilead Sciences for patent infringement over Truvada and Descovy, drugs that are crucial in preventing the spread of HIV. The suit asserts that some of the relevant patents are owned by the government because scientists from the Centers for Disease Control and Prevention (CDC) developed the breakthrough drugs. 

The Department of Health and Human Services (HHS) argues that Gilead has repeatedly refused to obtain licenses for the use of 4 CDC patents, but are making billions of dollars from the drugs. HHS secretary Alexander Azar says that while the government recognizes Gilead’s role in selling the anti-HIV medications to patients, the company “must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”  The lawsuit argues that “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith.”

Gilead disagrees with these allegations, arguing that the government patents are invalid and the work performed by the CDC was “obvious and proposed by others.” Gilead asserts that “The fact remains that Gilead invented Truvada and funded the clinical trials that led to its 2004 FDA approval for use in combination with other antiretroviral agents to treat HIV.”

Truvada and Descovy are PrEP (pre-exposure prophylaxis) drugs, an HIV prevention method for people who are at a high risk of acquiring HIV. When taken daily, these medications reduce the risk of getting HIV from sex by 99% and 74% for those who inject drugs. In his 2019 state of the Union address, President Trump established a goal of ending the spread of HIV in America by 2030. Lowering the price of PrEP, which can cost around $21,000/year, would significantly advance those efforts and some hope that the Gilead lawsuit itself may result in a price reduction.

(Peter Sullivan, The Hill)

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November 8, 2019 at 10:57 am

Science Policy Around the Web – June 25th, 2019

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By Ben Wolfson, Ph.D.

Image by Darwin Laganzon from Pixabay 

North Korea claimed to be free of HIV. But infections appear to be surging

Since its first diagnosis 1981, HIV/AIDS (Human immunodeficiency virus infection and acquired immune deficiency syndrome) has infected more than 70 million individuals worldwide and resulted in 35 million deaths.

HIV/AIDS is classified as a pandemic, with infected individuals found throughout the world. However, as of a December, 2018 World AIDS Day event, North Korea reported no known cases, crediting this to widespread testing and prevention methods.

A new paper has reported that these data were false, and that in fact following a North Korean “patient zero” in 1999, HIV/AIDS infections have slowly ballooned. These findings come from a collaboration between North Korean scientists and DoDaum, a nonprofit in North America that runs health and education projects in North Korea. While officials originally asked DoDaum not to discuss the increasing prevalence of HIV/AIDS in North Korea, the North Korean Ministry of Public Health felt they had to overcome traditional reticence in order to seek help in targeting HIV/AIDS.

While both a cure and vaccine remain elusive, widening usage of Pre-Exposure Prophylaxis (PrEP), also called Truvada, has the potential to significantly reduce new HIV infection. PrEP has been shown to be more than 90% effective at preventing new HIV infections, and remains underutilized in most countries, including the USA. This is in part due to cost, a factor which is the subject of a new bill introduced in the Senate that would make PrEP free to most patients.

(Richard Stone, Science)

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June 25, 2019 at 5:37 pm

Science Policy Around the Web – February 16, 2018

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By: Mohor Sengupta, PhD

Health Bacteria Cell Infection Microbiology Black

source: Max Pixel

Antibiotic discovery

A potentially powerful new antibiotic is discovered in dirt

Antibiotics have been in an ongoing, constant battle with the pathogens they are aimed to eliminate. Bacteria constantly mutate their genetic material to acquire resistance to anti-microbial drugs, making multi-drug resistance a global concern. Misuse or overuse of antibiotics contributes to this phenomenon. To address the issue of multi-drug resistance, a team of microbiologists at the Rockefeller University, NY, have conducted a large screen of natural products produced by soil-dwelling bacteria. According to Dr. Sean Brady, who heads the group, only a small fraction of the bacterial biodiversity is cultured in the lab and only a tiny fraction of chemicals produced by these bacteria are detectable. Identification of naturally produced chemicals by bacteria that have never been cultured in the lab provides a promising new direction towards anti-microbial therapies.

Dr. Brady’s group adopted a “culture-independent”, metagenomics approach to analyze chemicals secreted by unknown bacteria from soil samples. Their aim has not been to identify the bacteria in the samples but to look for DNA signatures associated with calcium dependent antibiotic properties. This means that the chemical they are looking for will act against bacteria only in the presence of calcium. After the identification of a gene potentially encoding a calcium dependent antibiotic, the researchers cloned it and made a laboratory grown bacteria (S. albus J1074) express it. The gene product is a new class of antibiotics that have been named “malacindin”. Dr. Brady’s research has shown that malacidins act by interfering with bacterial cell wall formation and have shown this antibiotic to be effective against a range of superbugs, including methicillin-resistant Staphylococcus aureus (MRSA). Calcium dependent antibiotics are believed to make it more difficult for the target bacteria to evolve resistance. Dr. Brady’s research was published in Nature Microbiology on February 12.

Conventional methods to isolate new antibiotics from laboratory cultured bacteria often lead to the same antibiotics being found over and over again, resulting in abandonment of such approaches in recent times. The novelty of Dr. Brady’s work lies in the use of natural sources, like soil, sewage, water etc. to isolate the genetic blueprint encoding anti-microbial chemicals, made easier with the use of metagenomics and large-scale sequencing. Researchers elsewhere are also using this approach to identify new antibiotics from natural sources. In the modern scenario of increasing deaths due to multi-drug resistance, this type of research is critical to rapid discoveries of novel antimicrobial therapies. Of course, getting the newly discovered drug into the market will not be fast, as Dr. Brady warns, yet this is an ingenious solution to discovering clinically useful antibiotics.

(Sarah Kaplan, The Washington Post)

Risk assessment

He Took a Drug to Prevent AIDS. Then He Couldn’t Get Disability Insurance

Pre-exposure prophylaxis (PrEP) is a practice of taking a drug to prevent HIV infection in persons with high risk of contracting it. In the year 2012, the F.D.A. approved Truvada, a drug originally approved for HIV treatment a decade earlier, for prevention of HIV infection (PrEP). Since then PrEP has become increasingly popular and as of 2017, an estimated 136,000 people in the United States were on PrEP. Several studies have shown that Truvada is highly effective in preventing HIV infection. However in the initial days of Truvada use,  some thought that individuals taking prophylaxis might overestimate its level of protection, leading them to engage in risky behavior they otherwise would have avoided. This belief is prevalent even today, as several insurance companies across the United States regularly deny disability and life insurance to men on PrEP on the basis that this treatment is indicative of an increased level of personal risk.

The repercussions of this policy, was exemplified when Dr. Philip J. Cheng of Brigham and Women’s Hospital at Harvard accidentally cut himself while preparing an HIV positive patient for surgery. The responsible behavior in this situation is to immediately take steps to prevent infection. Dr. Cheng did just that, by enrolling into PrEP. However, when he applied for a disability insurance, he was denied coverage because he was taking Truvada. He could not get the insurance company to cover him even after agreeing to sign a waiver of benefits in case he got infected.

Disability insurance is usually applied for by people whose livelihood depends on their income. For people like Dr. Cheng this insurance will guarantee him his lifetime of income in the case of a disability. Use of Truvada has not shown any adverse side-effects till date. In fact, it is said to be safer than aspirin, whose long term usage causes gastro-intestinal bleeding. It is a consensus among AIDS doctors across the USA that PrEP is necessary for individuals at high risk of contracting HIV. Denial of insurance to PrEP users by insurance companies has been likened to denying insurance for using car seat-belts by Dr. Robert M Grant, whose group led the clinical trial that established the importance of PrEP. Even more perplexing is the fact that life insurance companies are regularly providing insurance to people with other conditions that are managed by regular medications, like diabetes and heart diseases. Even former alcoholics who are now un-addicted are not denied.

Mr. Bennet Klein, a lawyer with Boston based GLAD, an organization of legal advocates and defenders of GLBTQ community has asked several insurance companies the reason for denying insurance to men on PrEP. In most interviews with various insurance companies he and others have heard a range of answers, some ambiguous. The general understanding is that insurance companies are increasingly following this trend because they suspect potential high-risk behavior in PrEP users. The crux here is that regardless of risky sexual behavior, PrEP is highly protective. A prominent work of research published in The New England Journal of Medicine in 2010 showed that tenofovir, one of the chief components of Truvada reduced the risk of HIV infection by 95 percent. The famous HPTN 052 clinical trial of 2011 also showed the efficacy of PrEP.

Because of the prevalence of insurance denials, several people, like Dr. Cheng have stopped using PrEP. It is critical that this trend is reversed, in the light of clear benefits of taking PrEP. While there are insurance companies that do provide disability and life insurance to PrEP users, cases like Dr. Cheng’s result in disappointment and eventual withdrawal from using PrEP.

(Donald G. McNeal Jr, The New York Times)

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February 16, 2018 at 4:58 pm

Science Policy Around the Web – December 15, 2015

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By: Rebecca A. Meseroll, Ph.D.

Photo source: pixabay.com

Climate change

Global climate change accord reached

After years of discussion and two weeks of intensive negotiations, representatives from 195 nations reached an historic accord on climate change on December 12th in Paris.  A major goal of the agreement is to maintain global temperatures at or below 2°C above pre-industrial temperatures, primarily by transitioning from fossil fuels to clean energy alternatives.  As the earth has already warmed approximately 1°C since pre-industrial times, it is crucial that action is taken to reverse the trend.  Although individual nations’ current climate pledges are not expected to fully meet this goal, many scientists see the accord as a means of gaining momentum to enact policies to prevent the terrible outcomes that rising global temperatures would deliver.

Of course, the agreement does require actual follow-through by individual governments in order to be effective.  The plan will utilize a system of global peer pressure to encourage nations to meet their goals by requiring that countries meet every five years beginning in 2023 to report on progress.  In the United States, for example, the fear of international shame may not be enough to force the hand of climate change skeptics in Congress who would likely vote against future legislation aimed at decreasing global temperatures.  Despite the imperfections of the agreement, the successful passage of this pact has led to a great deal of excitement, especially in the scientific community, and should provide a huge step forward in worldwide cooperation for improving environmental health. (Coral Davenport, New York Times; Jeff Tollefson & Kenneth R. Weiss, Nature)

AIDS research funding

NIH ends fixed funding for AIDS research

Last week, the National Institutes of Health (NIH) announced it will not continue allocating a set 10% of its budget to HIV/AIDS research, a policy which has been in effect since the early 1990s.  HIV and AIDS treatments have vastly improved in recent years and mortality rates are down, thus research into the disease is not seen as being such a pressing issue as it once was.  Francis Collins, the Director of the NIH, agrees with patient groups and Congressional representatives who have found it problematic that AIDS gets proportionally so much more research funding than other diseases that take a greater toll on the population and healthcare spending.  In addition to cutting the reservation of 10% of its overall budget, another $65 million, which comprises about 2% of the HIV/AIDS grants portfolio, will be freed up for new priorities in HIV/AIDS research.  The NIH will focus on preventing HIV, via vaccine development or other treatments, and finding a cure for the disease, instead of funding projects more tangentially related to HIV infection.  The current funding reduction and refocusing are expected to take place in the next fiscal year.  Although the HIV/AIDS research community is generally supportive of ensuring the highest priority research is funded, there is some concern that HIV/AIDS research funding will be passed over for increases if the NIH budget is raised in the future. (Jocelyn Kaiser, ScienceInsider)

Drug prices and regulation

Shkreli plans to spike price of Chagas disease drug

Martin Shkreli, a former hedge fund manager and current CEO of Turing Pharmaceuticals, rose to infamy earlier this year when his company acquired the rights to the decades-old toxoplasmosis drug Daraprim and then abruptly raised its price per pill from $13.50 to $750.  After public outcry, he pledged to lower his proposed price raise, but then withdrew that pledge, and he has recently said he should have raised the price of Daraprim even higher.  Shkreli is now poised to spike the price of another old drug, benznidazole, which treats Chagas disease, a parasitic infection most commonly encountered in Central and South America that can persist for many years and eventually cause cardiac and gastrointestinal trouble.  Last month, Shkreli acquired the biotechnology company KaloBios Pharmaceuticals and is currently awaiting FDA approval for KaloBios to be the sole distributor of benznidazole in the United States.  If KaloBios receives approval, Shkreli says he will raise the price of a course of treatment to between $60,000 and $100,000.  The CDC estimates that approximately 300,000 people in the United States have Chagas disease, although the vast majority of them are undiagnosed.  It is unclear how much of a market KaloBios would actually have for benznidazole, since the diagnosis rate is so low, but even if there is no market, the company could potentially sell the rights to the drug to turn a quick profit.  KaloBios is facing competition for FDA approval from Elea Laboratories, an Argentine company that currently supplies benznidazole.  These practices by Shkreli call into question whether current regulations aimed at increasing research and development of drugs for neglected diseases are actually effective or whether they are more frequently being abused as money-making schemes.  If the latter is true, new regulations may need to be put into place to prevent gaming of the system. (Andrew Pollack, New York Times)

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December 15, 2015 at 9:00 am

The remarkable efficacy of HIV pre-exposure prophylaxis could change the trajectory of the HIV epidemic

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By: Elisavet Serti, PhD

The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that in 2013, there were 35 million [33.2–37.2 million] people living with HIV globally, despite widespread awareness of the modes of transmission and the protective benefits of condom use. As of June 2014, only 13.6 million of these people living with HIV had access to antiretroviral therapy. The most alarming statistic is that 19 million of these people do not know their HIV-positive status, according to a new report by UNAIDS. It appears that individuals at risk for HIV infection are still participating in risky sexual behavior and that more education about HIV and AIDS prevention is crucial.

In the United States, complacent attitudes among young adults towards HIV/AIDS infection are on the rise, in part, due to increasingly effective therapies that improve the disease’s manageability. The fact that HIV/AIDS is no longer an automatic “death sentence” could possibly explain lax attitudes among young people when it comes to safe sex practices to avoid infection, such as condom use. As such, the approval of Truveda – a daily, oral pill indicated for pre-exposure prophylaxis (PrEP) – by the Food and Drug Administration (FDA) in 2012 was hailed as a victory by the medical community. Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. A PrEP indication means that Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing. In an FDA press release, Truvada was described as “the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for PrEP in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.” The FDA Commissioner, Margaret A. Hamburg M.D., marked its approval as “an important milestone in our fight against HIV.”

When HIV researchers showed that people likely to be exposed to HIV could significantly decrease their risk of infection by taking one pill, many researchers immediately raised doubts about the pill’s real-world efficiency. Some scientists and health care workers rejected PrEP stating that this strategy could potentially undermine the traditional and still necessary ways of anti-HIV protection, such as safe-sex practices like condom use. Additionally, some at-risk people have not used PrEP because they fear it will brand them as promiscuous or reckless. Young, single women appear especially reluctant to use the drug, again because of the fear of a social stigma. The pill has also raised controversy in the gay community. The husband of an HIV-positive man who is taking PrEP regularly and remains HIV-negative said in a recent interview, “there’s a real stigma against this drug. Any young gay man that considers using Truvada is viewed as somebody who must be putting himself at great sexual risk for HIV.” It has been shown that men who have sex with men (MSM) carry a disproportionate burden of being infected with HIV compared with general population samples from low- and middle-income countries in the Americas, Asia, and Africa. MSM is a term coined in 1994 to reduce stigma against gay, bisexual, transgendered, and self-identified heterosexual men who engage in sex with other men, by describing behaviors rather than social or cultural identities. The odds for HIV infection in MSM are elevated across prevalence levels of MSM-associated HIV infection by country and decrease as general population prevalence increases, but remain 9-fold higher in medium-high prevalence settings. MSM from low- and middle-income countries are in urgent need of prevention and care, and appear to be both understudied and underserved.

Based on studies conducted primarily outside the United States of both high-risk men who have sex with men and heterosexual couples, Truvada has been shown to reduce the risk of acquiring HIV infection by more than 50% in several subgroups of patients when used daily in combination with a comprehensive HIV prevention strategy, including safer sex practices. The key factor for its effectiveness is the adherence to daily administration. Robert Grant, a top HIV researcher at the Gladstone Institutes and University of California at San Francisco and one of the pioneers of the PrEP approach, led a pivotal study of PrEP in 2010 with remarkable efficiency results. In this study, Truvada cut the rate of new infections in men who have sex with men and transgender women by 92% if they took the pill daily. Unfortunately, half of the participants failed to comply with the daily administration rules, which reduced the overall efficiency to 44%. A follow-up study included a large number of heterosexual “discordant” couples, in which only one partner was infected, found that adherence was much better, yielding 75% protection. There has been a lot scientific controversy from the publication of these studies, with other research groups raising questions about the economic impact of this prevention strategy, the side effects (e.g., renal insufficiency), the potential emergence of drug resistance (in patients with HIV and hepatitis B virus infection), the chance of risk compensation (increased high-risk sexual behavior) of the uninfected recipients of PrEP, and the age difference between experimental groups of the study.

Dr. Grant has continued his PrEP research and published a modeling study of the San Francisco epidemic, in which only 31% of people at high risk of infection used the PrEP regimen at some point last year, showing again that the potential payoff of widespread PrEP could be huge. If 65% of these people used the PrEP regimen for 12 months, the number of annual new infections would be halved. That drop could double again by aggressive use of both PrEP and antiretroviral treatment. “We’re at a tipping point where PrEP was a proven concept of unknown applicability,” Grant stated in a recent Science article, “and what’s most exciting is we can now see that is feasible.”

Dr. Anthony Fauci, who has headed the National Institute of Allergy and Infectious Diseases since 1984 and was one of the leading researchers involved in developing antiretroviral therapy for HIV, stated that Truvada is “highly efficacious, in my mind easily over 90 percent if you adhere rigidly to it.” He was quick to add, in line with the guidelines from all the United States government agencies, that the use of Truvada should be purely a preventive measure, that it’s meant to augment the protection provided by condoms, not to replace them. Still, having one more tool to add to the arsenal against HIV/AIDS is a great step forward in combating the spread of this disease.

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April 8, 2015 at 9:00 am

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Science Policy Around the Web – August 29, 2014

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By: Jennifer L. Plank, Ph.D.

photo credit: itmpa via photopin cc

GMOs

Brazil Considers Transgenic Trees – In September, a public hearing in Brazil will be focused on commercialization of transgenic Eucalyptus trees that have the potential to produce 20 percent more wood. So far, genetically modified trees from major commercialized species have been planted on a large scale suggesting that this hearing will have global implications. Despite potential environmental advantages, the GMO trees have received much opposition. One cause of opposition is the length of time the trees will be alive compared to other GMO crops such as soy and corn. Meanwhile, in the United States, another company, who has generated freeze-resistant eucalyptus, is anxiously awaiting the ruling in Brazil.  (Heidi Ledford)

 

Infectious Disease and Public Health

AIDS Progress in South Africa is in Peril – Until recently, the AIDS epidemic in South Africa has kept undertakers in business. However, within the past 6 years, there has been a dramatic increase in the ability to treat and prevent the spread of HIV. There has been a drastic increase in the number of clinics and health care practitioners prescribing antiretroviral drugs. In fact, each month 100,000 new patients begin a regiment of anti-retroviral drugs, more than any other country in the world. Additionally, maternal to fetal transmission has decreased 90 percent. All of this suggests an astounding success in South Africa. Much of this success can be attributed to the US program PEPFAR, the President’s Emergency Plan for AIDS Relief. Unfortunately, with the PEPFAR pipeline drying up, the programs in South Africa are in danger of not being able to continue their work. (Donald G. McNeil Jr.)

 

Vaccines

Ebola Vaccine to be tested in humans at NIH Clinical Center this fall – In collaboration with GlaxoSmithKline, NIH researches will begin clinical trials of an Ebola vaccine. The trial will test the safety of the vaccine and its ability to induce an immune response. The initial trial will include approximately 20 participants. Similar trials will be conducted in other countries. (Brady Dennis)

 

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August 29, 2014 at 3:21 pm