Feds Fund Implantable PrEP Study

Poz.com reports:

A group of 15 researchers and clinical investigators at Northwestern University received a $17.5 million grant to develop an implant capable of delivering meds that protect against HIV, according to a press release from the McCormick School of Engineering. The hope is that the implants would last for up to a year. The five-year project is underwritten by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. It brings together researchers from 15 different departments at Northwestern, including Feinberg School of Medicine, Kellogg School of Management and McCormick School of Engineering. In the first stage of the project, researchers hope to develop implants that deliver HIV meds in a controlled way. As Kiser noted: “Technology like this could be an important tool in fighting the global HIV/AIDS pandemic in the U.S. and in low-income countries.”

(Tipped by JMG reader Bill)

Ebola Vaccine Trial: 100% Effective

Via Science Magazine:

A highly unusual clinical trial in Guinea has shown for the first time that an Ebola vaccine protects people from the deadly virus. The study, published online today by The Lancet, shows that the injection offered contacts of Ebola cases 100% protection starting 10 days after they received a single shot of the vaccine, which is produced by Merck. Scientists say the vaccine could help to finally bring an end to the epidemic in West Africa, now more than 18 months old. "This will go down in history as one of those hallmark public health efforts," says Michael Osterholm, the director of the Center for Infectious Disease Research and Policy in Twin Cities, Minnesota, who wasn't involved in the study. "We will teach about this in public health schools."

The vaccine was developed by the Public Health Agency of Canada.

STUDY: HIV Transmission Is Virtually Zero For Patients "Reliably" Taking Their Meds

Via the Charlotte News & Observer:

Groundbreaking research conducted at UNC-Chapel Hill has demonstrated that potent drug cocktails can disable HIV to the point that the deadly virus can’t be transmitted to other people through sexual activity. The findings were announced Monday by AIDS researcher Myron Cohen at the eigth International AIDS Society Conference in Vancouver, Canada. Cohen, UNC’s chief of the Institute for Global Health & Infectious Diseases, has headed the global research project for a decade and studied more than 1,700 couples.

The landmark study, financed with more than $100 million in federal research grants, confirmed initial results reported in 2011 and demonstrated that AIDS medications known as antiretroviral therapy, or ART, can suppress the virus for years. The virus can reemerge if the patient stops taking the medicine, but as long as it’s suppressed, the virus essentially is harmless and most patients can lead normal, healthy lives. “If people are taking their pills reliably and they’re taking them for some period of time, the probability of transmission in this study is actually zero,” Cohen said by phone from Vancouver. “Let me say it another way: We never saw a case of HIV transmission in a person who is stably suppressed on ART.”

The researchers stressed that they are not advocating unprotected sex for those taking anti-retrovirals.

Nursing Group Opposes "Ex-Gay" Torture

Via press release:

The Academy concludes that reparative therapies aimed at “curing” or changing same-sex orientation to heterosexual orientation are pseudo-scientific, ineffective, unethical, abusive and harmful practices that pose serious threats to the dignity, autonomy and human rights as well as to the physical and mental health of individuals exposed to them. Based on sound scientific evidence, its commitment to human rights and dignity, and its mission of promoting positive health outcomes for lesbian, gay, bisexual, transgender and queer (LGBTQ) individuals, the Academy concludes that efforts to “repair” homosexuality, by any means, constitute health hazards to be avoided and are to be condemned as unethical assaults on human rights and individual identity, autonomy and dignity,” the Academy said in its statement on reparative therapy. The statement cited strong scientific evidence concluding that techniques used in reparative therapies are ineffective by failing to achieve intended results and imparting inherently harmful effects on mental and physical health on individuals being pressured to change.

See the full statement. Also today the group issued a statement opposing employment discrimination on the basis of sexual orientation or gender identity.

GSK & UNC-Chapel Hill Form Company Devoted To Finding Cure For HIV/AIDS

Via the New York Times:

Years ago, curing AIDS was considered so out of the question that some scientists dared not even mention the possibility. But in the latest sign that attitudes are changing, the British pharmaceutical giant GlaxoSmithKline is teaming up with the University of North Carolina at Chapel Hill to start a research institute and a company aimed at curing H.I.V. infection and AIDS. In an agreement set to be announced on Monday, GlaxoSmithKline will contribute $4 million annually over five years to the research center, set up on the North Carolina campus. It will also move a small number of its own scientists to Chapel Hill. The company and the university will each own half of the new company, Qura Therapeutics, which will have the rights to commercialize any discoveries. The effort will be separate from ViiV Healthcare, the company owned by Glaxo, Pfizer and Shionogi that develops and sells drugs that control, but do not cure, H.I.V.

More from Buzzfeed:

The first approved drug for HIV, azidothymidine or AZT, was patented in 1985 by Burroughs Wellcome, which was subsequently acquired by GSK. At UNC-Chapel Hill, molecular biologist David Margolis and his colleagues have made headlines for their strategy to root out HIV from its many hiding spots (known as “latent reservoirs”) in the body — even in patients already treated with antiretroviral therapy. With that line of research, “what was once provocative and unthinkable became mainstream: let’s try and cure AIDS,” Myron Cohen, chief of the Division of Infectious Diseases at UNC-Chapel Hill, told BuzzFeed News. That scientific strategy, informally known as “shock and kill,” will be at the center of the GSK-UNC collaboration. The leaders of the new effort recognize that their initial investment is fairly small, on the scale of what it takes to develop a new drug. They hope to be a catalyst for more funding — from the government and, perhaps, from other companies — later on.

And from the Wall Street Journal:

AIDS researchers have known for two decades that HIV goes dormant, hiding in so-called latent reservoirs in immune-system cells where it can’t be affected by antiretroviral drugs. UNC has led one potential strategy for a cure in which a drug is used to flush the virus from its dormant state, making it a target for drug therapy. Dr. David Margolis said that strategy is “extremely promising,” but that the cure center will explore others. “We have to have a broad approach,” he said. UNC Chancellor Carol Folt said the hope is that the partnership will expand, inviting in additional collaborators. “I see this as us really putting our muscle behind a pressing issue,” she said, calling an HIV cure “an extraordinary scientific challenge.” In 2013, about 35 million people world-wide were infected with HIV, and 1.5 million people world-wide died of AIDS-related causes, according to the Joint United Nations Program on HIV/AIDS.

Posted today to GSK's YouTube channel.

Researchers Claim Success With Implant Which Delivers HIV Meds For 40 Days

Via Science Daily:

Scientists from the Oak Crest Institute of Science, in Pasadena, CA, report that they have developed a matchstick size implant, similar to a contraceptive implant, that successfully delivers a controlled, sustained release of ARV drugs for up to 40 days in dogs with no adverse side effects. "To our knowledge this is the first implant to be used for this purpose," says Dr. Marc Baum, president and founder of Oak Crest.  Daily administration of oral or topical ARV drugs to HIV negative individuals in vulnerable populations is a promising strategy for HIV prevention. However, adherence to the dosing regimen has emerged as a critical factor in determining effective outcomes in clinical trials. "This novel device will revolutionize how we treat or prevent HIV/AIDS as it delivers powerful HIV-stopping drugs and eliminates one of the key obstacles in HIV/AIDS prevention -- adherence to proper dosing regimens," he adds.

The team plans to develop a new version of the implant that would deliver the medications for a full year.

NEJM To SCOTUS: Say Yes To Marriage

The New England Journal of Medicine is the nation's oldest continuously published peer-reviewed medical journal. Posted today:

Eleven years ago, Massachusetts became the first state in the country to give same-sex marriages full legal recognition. Today, same-sex marriage is legal, through legislative or judicial action or by popular vote, in more than 35 states and the District of Columbia. It is recognized by the federal government. And polls consistently show that it is supported by a clear majority of Americans. However, in Ohio, Kentucky, Michigan, and Tennessee, the Sixth Circuit Court of Appeals has ruled in favor of laws and constitutional amendments that define marriage as a union between a man and a woman only, denying recognition of same-sex marriage. Given the conflicting lower-court rulings, the Supreme Court has taken the issue under consideration. The Court will hear oral arguments on April 28 and is expected to hand down its ruling by the end of the current session, in June. We believe that the Court should resolve this conflict in favor of the full recognition of same-sex marriage throughout the United States.

Read the rest. (Tipped by JMG reader TJ)

Court: Chimpanzees Are Legal Persons

NPR reports:

A New York judge has granted two research chimps the writ of habeas corpus – a move that allows them to challenge their detention. The decision, says Science magazine, effectively recognizes chimps as legal persons, marking the first time in U.S. history that an animal has been given that right. The order, dated April 20, requires Stony Brook University to appear in court and provide a legally sufficient reason for keeping the two chimps, Hercules and Leo. A hearing is scheduled for May 6.

The Nonhuman Rights Project (NhRP), the group that filed the case on behalf of the chimps, said in a statement it believed the Manhattan Supreme Court Justice Barbara Jaffe's order "implicitly determined that Hercules and Leo are 'persons.'" But Richard Cupp, a law professor at Pepperdine University who opposes personhood for animals, told Science, "It would be quite surprising if the judge intended to make a momentous substantive finding that chimpanzees are legal persons if the judge has not yet heard the other side's arguments."

Read more at Science.

SOUTH AFRICA: Surgeons Announce World's First Successful Penis Transplant

The Washington Post reports:

In a nine-hour surgery, a South African medical team successfully transplanted the penis of a dead donor to a young man without one. Three months later, they say, the recipient, who lost his penis because of complications from a ritual circumcision, has a totally functional sexual organ. That makes him the first successful recipient of a donated penis. To get the approval of the donor's family, doctors had to fashion a pseudo-penis for him out of abdominal skin. That way he could be buried with something resembling a penis. South Africa has a greater need for penis transplants than most of the world. Young men who are members of the Xhosa people often undergo ritual circumcision, sometimes in rural areas without proper instruments or sterilization. Complications from this practice lead to an estimated 250 penile amputations each year.

The surgical team now has nine patients awaiting donated organs.

FDA Approves "Functional HIV Cure" Trials

Via Medical Daily:

A possible “functional cure” for HIV has recently been granted FDA approval for further human testing. The method uses genetic modification to cause a specific mutation in the white blood cells of HIV patients which mirrors those found in the naturally immune. It has so far shown to be both receptive and long-lasting.

The novel therapy involves taking stem cells from HIV-infected patients and using a gene editing tool to cause them to form into white blood cells with a specific mutation. The mutation affects a protein known as CCR5, and interferes with the virus’s ability to latch onto blood cells. The mutation occurs naturally in a small percentage of the world’s population and gives these individuals a life-long resistance to HIV infections. Although the virus may remain in their body, without being able to enter the T cells, it cannot replicate and therefore will stay at low numbers, uncompromising the immune system.

In theory, when these genetically edited stem cells are reintroduced into HIV patients they will repopulate the body with cells possessing the same mutation. This would give the patients the same lifetime resistance to the virus’s harm with just one procedure. The method was developed by Sangamo BioSciences Inc., but has also been tested in early human clinical trials by drug research company Calimmune. 

San Francisco's KQED reported on this development on Friday.

(Tipped by JMG reader Paul)

Short Film on PrEP: Unwrapping Truvada

Featuring Dan Savage, Cleve Jones, San Francisco Supervisor Scott Wiener, and AIDS Healthcare Foundation head Michael Weinstein.

(Tipped by JMG reader Eric)

A Live Look At Simian HIV

Via Science Magazine:

Show me the monkey. Seeing is believing, and a study in rhesus macaques with a new imaging technique reveals for the first time a real-time map of an AIDS virus replicating in the entire body of a living animal. The results point to some unexpected hideouts of the simian AIDS virus, or SIV. And the experiments also show that when the monkeys are given antiretroviral (ARV) drugs, the amount of virus that persists differs by location in the body. The innovative tool promises to clarify the still-murky details of the initial infection process and may help guide drug, vaccine, and cure research in people. “It’s fantastic,” says Thomas Hope, an immunologist at Northwestern University Feinberg School of Medicine in Chicago, Illinois, who investigates how HIV, the human counterpart to SIV, infects cells. “The whole monkey shows you things you can’t comprehend by just looking at cells or biopsies of tissues.”

Fascinating details are at the link.

FLORIDA: Researchers Announce Possible Breakthrough In Search For HIV Vaccine

Via Science Daily:

In a remarkable new advance against the virus that causes AIDS, scientists from the Jupiter, Florida campus of The Scripps Research Institute (TSRI) have announced the creation of a novel drug candidate that is so potent and universally effective, it might work as part of an unconventional vaccine. The research, which involved scientists from more than a dozen research institutions, was published February 18 online ahead of print by the journal Nature.

The study shows that the new drug candidate blocks every strain of HIV-1, HIV-2 and SIV (simian immunodeficiency virus) that has been isolated from humans or rhesus macaques, including the hardest-to-stop variants. It also protects against much-higher doses of virus than occur in most human transmission and does so for at least eight months after injection. "Our compound is the broadest and most potent entry inhibitor described so far," said Michael Farzan, a TSRI professor who led the effort. "Unlike antibodies, which fail to neutralize a large fraction of HIV-1 strains, our protein has been effective against all strains tested, raising the possibility it could offer an effective HIV vaccine alternative."

When HIV infects a cell, it targets the CD4 lymphocyte, an integral part of the body's immune system. HIV fuses with the cell and inserts its own genetic material -- in this case, single-stranded RNA -- and transforms the host cell into a HIV manufacturing site. The new study builds on previous discoveries by the Farzan laboratory, which show that a co-receptor called CCR5 contains unusual modifications in its critical HIV-binding region, and that proteins based on this region can be used to prevent infection. With this knowledge, Farzan and his team developed the new drug candidate so that it binds to two sites on the surface of the virus simultaneously, preventing entry of HIV into the host cell.

The study was funded with grants from the NIH.

All-Time Low For HIV/AIDS In NYC

Via the New York Observer:

The New York City Department of Health and Mental Hygiene released a new report Monday–coinciding with the 26th annual World AIDS Day–declaring that New York HIV diagnoses have reached an all-time low. The report shows that in NYC in 2013, 2,832 people were newly diagnosed with HIV and 1,784 people were diagnosed with AIDS. These figures are dramatically lower than those recorded ten years ago: 7,744 HIV diagnoses and 5,422 AIDS diagnoses. Although HIV diagnoses have dropped over 40 percent and AIDS diagnoses plummeted over 65 percent, Health Commissioner Dr. Mary Bassett said, “I am proud to celebrate an historic low for new HIV diagnoses in New York City, but, 2,800 individuals newly infected with HIV are still too many people. We must strive harder to reach communities of color, which bear the highest burden of HIV.”

The number of AIDS-related deaths in 2013 was also a new low at 1527. At the peak of the epidemic in the early 90s over 12,000 new HIV cases were being reported in New York City annually, with deaths peaking at 8200 in 1996 just as anti-retroviral therapy was approved by the FDA. An estimated 117,000 New Yorkers are presently living with HIV and nearly half are over 50 years old. Young black and Latino gay and bisexual men living in poor neighborhoods continue to suffer a highly disproportionate number of new infections.

Study: HIV Is Weakening Over Time

Via Reuters:

Rapid evolution of HIV, the human immunodeficiency virus, is slowing its ability to cause AIDS, according to a study of more than 2,000 women in Africa. Scientists said the research suggests a less virulent HIV could be one of several factors contributing to a turning of the deadly pandemic, eventually leading to the end of AIDS. "Overall we are bringing down the ability of HIV to cause AIDS so quickly," Philip Goulder, a professor at Oxford University who led the study, said in a telephone interview. "But it would be overstating it to say HIV has lost its potency -- it's still a virus you wouldn't want to have." Some 35 million people currently have HIV and AIDS has killed around 40 million people since it began spreading 30 years ago. But campaigners noted on Monday that for the first time in the epidemic's history, the annual number of new HIV infections is lower than the number of HIV positive people being added to those receiving treatment, meaning a crucial tipping point has been reached in reducing deaths from AIDS.

The study was conducted in South Africa and Botswana.

MAP: What EU Nations Are Worst At

The categories for France, Denmark. and Romania are really dumb compared to the seriousness of the others. Visit Thrillist for a breakdown. A huge version of the map is here. (Via JMG reader Aaron)

Injectable PrEP Study Advances

Via AIDSMap:

Researchers have determined the dose of an injectable formulation of the integrase inhibitor cabotegravir (formerly GSK744) that will be taken into efficacy trials to see if it can be used for pre-exposure prophylaxis (PrEP). Studies in animals were presented earlier this year suggesting that drug levels stayed high enough in the body for it to be injected quarterly, and now studies of drug concentration in humans have confirmed that an 800mg intramuscular injection will be given once every twelve weeks in efficacy trials. Progress on an injectable formulation of another drug, rilpivirine, received a setback, however, when animal studies showed it lost its efficacy against viral challenge after only 18-21 days.

Would be easier to get somebody to visit their doctor for a quarterly injection than it would to get them to take a daily (or less frequent) pill at home? (Tipped by JMG reader Bill)

CDC Issues New Ebola Quarantine Rules

Obama Addresses Nation On Ebola

Via the Associated Press:

President Barack Obama says the U.S. must be guided by science - not fear - as it responds to Ebola. In his weekly radio and Internet address, Obama says he was proud to give Texas nurse Nina Pham a hug in the Oval Office after she was cured of Ebola. He says the other nurse who contracted Ebola is also improving. Obama is praising New York's quick reaction to its first Ebola case. He says he's promised local officials any federal help they need. Obama is reminding Americans they can't contract Ebola unless they come into direct contact with a patient's bodily fluids. The president says the U.S. can beat the disease if it remains vigilant. He says the best way to stop it is at its source in West Africa.

Today's New York City Tabloids