Treat early. That’s become the mantra of the AIDS world. While previous studies have shown that early treatment benefits infected individuals, now a watershed study shows it prevents them from spreading the virus to others. According to results of the major clinical trial, patients were 96 percent less likely to pass on the virus if they took antiretroviral drugs early on. That’s a staggering figure.

“These results are phenomenal,” Thomas J. Coates, PhD, at UCLA was quoted as saying in the New York Times. “It was a tough study to do, and I’m thrilled it came out this way.” Coates is a guru of the AIDS prevention world; he founded the Center for AIDS Prevention Studies at UCSF, where I collaborated with him in 1998 on a monograph on new AIDS drugs.

The study is not the first to suggest that early treatment prevents transmission, but it is the first randomized clinical trial to validate the strategy. The $73 million trial was scheduled to end in 2015 but was halted early by the NIH, its sponsor, because the results were so compelling.

The trial, begun by researchers at the University of North Carolina at Chapel Hill in 2005, involved 1,763 heterosexual couples at 13 sites in the United States and abroad. In one group, patients identified as HIV-positive were given drugs immediately. In the second group, infected patients received drugs only after their CD4 counts - a measure of immune system health - fell below 250 or they developed an AIDS-related complication. Both sets of couples were counseled on safe sex, given free condoms and regularly tested for HIV.

There were 27 new infections among the 877 couples in which the HIV-infected individual did not receive treatment right away. Only one new infection was found among those where the HIV-infected partner began immediate antiretroviral treatment.

These dramatic findings are sure to changing the prescribing habits of physicians, making it clear that early access to treatment is critical.

HIV-positive women who breastfeed their babies are at high risk of passing the virus on to their infants. As many as 30 percent of the children who are infected with HIV today contracted the virus through breast milk.

But an important new study finds that newborns can be protected from infection with prolonged treatment with the antiretroviral drug nevirapine, which was found to be safe for the infants. The researchers concluded that babies treated for six months with the drug fared better than those who received the standard, 6-week course of treatment. The results of the study are significant and are likely to change international guidelines and clinical practices for babies born to HIV-infected mothers.

The study included more than 1500 mothers and their babies in four African countries - South Africa, Tanzania, Uganda and Zimbabwe - all of which have rates of HIV/AIDS. Yvonne Maldonado, MD, chief of pediatric infectious disease at Stanford, presented the results today at the Conference on Retroviruses and Opportunistic Infections, being held in Boston, Mass. Maldonado has been working for more than a decade in Zimbabwe on methods to prevent mother-to-transmission of the AIDS virus.

The study found that the treatment benefits for the infants were even more pronounced among those with mothers who weren’t getting antiretroviral therapy for their own health. The World Health Organization recommends that pregnant women who are HIV-positive receive this therapy when their CD4 count - or the number of infection-fighting T-cells - drops below 350. These treated women are less likely to pass on the virus to their offspring through breast milk.

But many pregnant women don’t get this treatment because their T cell counts are above 350, so their unborn children may be left vulnerable to HIV infection through breastfeeding. Now the study shows for the first time that treating the infants alone for six months or more can protect them.

“So this is a big leap,” Maldonado told me. “This study is the first to provide concrete evidence that even just infant prophylaxis without maternal treatment of ‘healthy’ HIV-infected women with high CD4 counts will work.”

Ukraine has one of the fastest growing HIV epidemics in the world, fueled largely by a rise in intravenous drug use. About half of the country’s 390,000 drug users are infected with HIV, and the virus is starting to spread into the general population.

In a new study, Stanford researchers found that the best way to combat the epidemic in Ukraine was to hit it two ways: first by offering substitute drugs, such as methadone, for opiate users and then providing antiretroviral therapy to infected individuals. In doing so, some 8,000 new infections could be prevented over the next 20 years, the researchers found. From a release:

“HIV is spreading in Eastern Europe more quickly than in any other part of the world,” says Margaret Brandeau, PhD, a Stanford professor of engineering. “Our study shows that substitution therapy for injection drug users is an inexpensive and effective means of curbing HIV transmission in the region.”

Although the Ukranian government has endorsed a plan that includes substitution therapy, at the same time AIDS rights groups have reported that patients receiving the therapy are being subject to harassment:

“At a time when hope should be on the rise thanks to the new HIV law, the ministry’s new policy direction has had a chilling effect on treatment programs,” says Sabina Alistar, a doctoral student in engineering who was the lead author of the study.

The researchers found that providing drug substitution therapy alone, while beneficial, was not as effective as providing both drug substitution and antiretroviral treatment. Antiretroviral treatment not only helps the infected individuals, but also reduces the amount of virus they carry so they are less likely to transmit it to others in the general population, notes Douglas Owens, MD, a professor of medicine at Stanford and one of the study’s co-authors.

At a time of political tensions between the United States and North Korea, researchers at Stanford’s medical school have been able to reach across the divide, creating a first-ever partnership with the North Korean government to help fight tuberculosis in the Asian nation.

North Korea is believed to have among the highest incidence of TB in the world outside of sub-Saharan Africa, with a rate of 345 cases per 100,000 people, the researchers write (registration required) in today’s issue of Science. Moreover, the country is thought to have a substantial problem with multi-drug resistance (MDR), which can threaten global control of the disease, the researchers say.

Over the last two years, epidemiologist Sharon Perry, PhD, professor of medicine Gary Schoolnik, MD, and a team of microbiologists from Stanford and Bay Area public health programs have made several visits to North Korea to establish a modern TB laboratory and train public health officials so they can accurately diagnose multi-drug resistant disease and then treat patients accordingly. The work has been done in collaboration with the Christian Friends of Korea, with support from the nonprofit Nuclear Threat Initiative.

Why is this so important?

Beyond the pressing humanitarian issues, the fact is that TB is a significant global threat. The bacteria is not only highly infectious but also deadly: Half of those who go untreated die, and because of their exposures to others, they may spawn between 10 and 20 new cases, the researchers note. The bacteria doesn’t respect borders; for instance, multi-drug resistant strains that thrived in Russia following the fall of the Soviet Union have turned up in Western Europe, the Middle East and South Africa, according to the researchers. And:

The modern MDR-TB epidemic reminds us that the loss of TB control leaves costly legacies, for which the world community is ultimately responsible. As discussions continue about how to deal with North Korea, it is important to remember that decisions made in a narrow security arena can have far-reaching global health consequences. Efforts such as the TB laboratory project are evidence that engagements based on mutual health interests are not only possible, but also crucial to sustain.

Previously: Stanford researcher talks about TB project in North Korea

For four years, it’s been recommended by the federal Centers for Disease Control and Prevention that everyone between the ages of 13 and 64 be tested for HIV. But how many people really get this test? Not enough, say researchers at Stanford. And that’s one reason HIV continues to spread: 21 percent of people in this country who are infected don’t even know it, so they may be inadvertently passing it along to others, according to the CDC.

Given that, the Stanford scientists decided to look at the value of building an expanded national HIV testing and treatment program throughout the United States. In a new study, they report that screening high-risk people every year and low-risk people once in their lives would be a very cost-effective approach, preventing as many as 212,000 new infections over the next 20 years. The study came out today in the Annals of Internal Medicine.

“We find that expanded screening and treatment could offer substantial health benefits, preventing 15 to 20 percent of new cases,” Elisa Long, PhD, the study’s lead author, told me.

For the program to be most effective, people who tested positive would have to be treated with antiretroviral medications and change their risky behaviors, the researchers found. Treatment would not only prolong their lives and avoid hefty hospital bills, but also would lower the amount of virus they’re carrying so they would be less likely to transmit it to others, Douglas Owens, MD, one of the study authors, told me.

If you scale up screening but those people don’t get treatment, you don’t get as much benefit. If you scale up treatment but still have a lot of people who aren’t identified, then they aren’t going to benefit. You do the most for health outcomes by scaling up these programs together. They are synergistic.

From December 20 to January 3, Scope will be on a limited holiday publishing schedule. During that time, you may also notice a delay in comment moderation. We will return to our regular schedule on January 3.

Two monumental pieces of news on AIDS hit the front pages of the New York Times today - both relating to prevention but in very different ways. First, Pope Benedict acknowledged that the need to prevent AIDS through use of condoms could outweigh the church’s longstanding opposition to this form of birth control. This is a huge step forward, particularly for the estimated 158 million Catholics in Africa, where AIDS has had the greatest impact and where the church has an enormous influence.

While in Africa, I met many in the Catholic Church fighting the epidemic against AIDS and they have felt hamstrung by the church’s lack of support for condoms. In Kenya, I became friends with a priest-turned-AIDS activist named Father Daniel Kiriti, who said he privately counsels young people on condom use but could not advocate it in large-scale settings because it was not officially sanctioned by the church. Now his Sunday sermons, which draw thousands, could be a platform for advocating this valuable form of HIV prevention.

The second piece of news came in the form of a study, published in the New England Journal of Medicine, which found that a single antiretroviral pill, taken faithfully, could prevent HIV as much as 90 percent of the time. The study involved nearly 2,500 men in six countries.

“Ninety percent effectiveness is really quite something,” Douglas Owens, MD, a professor of medicine at Stanford and an HIV policy researcher, told me. “That’s amazing.”

Owens noted that these results are even better than those that emerged this summer at the International AIDS Conference, where it was reported that women who used a microbicide gel before and after sex could reduce their chances of infection by 39 percent. Those results were greeted with great excitement in the AIDS community, as was the latest study.

The pill still has to be tested in other populations and could prove to be expensive, but it offers a very bright prospect indeed for an epidemic that seems otherwise unlikely to be controlled in the near future.

I remember the first time I saw a woman in Africa die of AIDS. Susan Andukais, just 36, was entombed on the only bed in a tin shack in Naivasha, Kenya, a wasted figure barely able to lift her hand in greeting. Susan left behind four children when she died three weeks after I visited her. It was 2004, when antiretroviral drugs weren’t much available to patients in Africa, and I was stunned - and furious - to see someone die of a disease I knew was eminently treatable.

Since then, more than 4 million people have gained access to these precious, life-giving drugs. And a new study from Stanford researchers says the reason is two-fold: because drug prices have dropped precipitously and because governments have pumped an enormous amount of foreign aid into AIDS treatment.

But neither of these trends is likely to continue, so the prospects for universal access to care - providing drugs to the millions who need them - remains remote indeed. The researchers calculate it would cost a stunning $15 billion a year to reach the oft-heralded goal of universal access.

“The things we have been doing are extraordinary in terms of reducing antiretroviral prices and mobilizing resources from the wealthy countries,” Eran Bendavid, MD, first author of the new study in the British Medical Journal, told me. “But we’re reaching the point where we can’t further reduce drug costs. So it’s up to the people with the purse strings to decide how close we’ll get to universal access.”

Moreover, foreign aid is down amid the global economic downturn, and the major funders of AIDS care, including the U.S. government, aren’t increasing their contributions at the same rate and are changing their priorities. Bendavid says we’ll just have to find a way to make better use of the resources we have. But where does that leave the patients? It troubles me greatly to think of the other Susans who are likely to die now.

Previously: AIDS war in Africa is failing and Trimming treatment for AIDS patients

As soon as he heard the words “stem cell” Lorry I. Lokey said he wanted in. Lokey, the philanthropist and founder of Business Wire, jumped in big time, contributing more than $75 million to help construct the country’s largest stem research building. The Lorry I. Lokey Stem Cell Research Building officially opened its doors today at Stanford, becoming what Lokey calls “the crown jewel” of the scientific world.

“We’re looking 10 years from today, and it’s just possible because of this building and the some of the best brains in the world who inhabit it, that 200 million lives will be extended or saved,” Lokey recently told me.

He believes stem cells will have a major impact on some of the prime killers in the United States, such as diabetes, heart disease and cancer, thus preventing much human suffering and premature death.

“This is the coming science,” he said, “just as Silicon Valley became the country’s big industry.”

Earlier this week, I stopped by the building and got a glimpse of some of its precious inhabitants - tiny stem cells clinging to the sides of a petri dish like rain drops on a window. The cells I saw were iPS, or induced pluripotent cells, taken from a patient with a rare skin disease and then reprogrammed to behave just like embryonic stem cells. These unique cells have the potential to turn into any kind of cell, with myriad possible applications in human disease. The researcher, Vittorio Sebastiano, PhD, briefly held up the plastic dish with its rare occupants and then carefully placed it back on the shelf in a warm incubator, in reverential fashion. I felt I was in the presence of something very significant.

Some 550 researchers in 33 different labs will move into the building between now and the end of the year. The building also has 60 “hotel” benches, where visiting scientists or clinicians can come and do research as well. They’ll work with the full range of stem cells, including embryonic and adult cell cells, cancer stem cells and disease-specific stem cell lines. These scientists, who hail from all over the world, will have many chances to mix and mingle, tackling conditions as diverse as cancer, spinal cord injury, heart problems and autoimmune disease. Just think of the possibilities.

Previously: Lorry I. Lokey Stem Cell Research Building to open on the Stanford campus and The largest stem cell research building in the U.S.

I joined a group of Stanford medical and graduate students this summer in a class that was unprecedented - the first in the country where students could have their own genotyping done. It took the medical school a year to approve the class, as it was rife with ethical concerns. Would students feel pressured to have this testing done? How would they react to potentially scary news - for instance knowing they had a much greater risk of Alzheimer’s or Parkinson’s? Would the genotyping be useful to them in understanding the process or simply cause them harm?

These were among the questions that were hotly debated among faculty members, including ethicists and genetics specialists, who sat on a school task force. Ultimately, the program was approved with some changes, making the genotyping optional and anonymous for students.

I was curious about how this 8-week experiment would play out and ultimately wrote about the results in an article in the current issue of Stanford Medicine magazine. The graduate student who proposed the class, Keyan Salari, invited some of its major critics to come and lecture, and they did not mince words. Neurologist Michael Greicius, MD, strongly urged the students not to go for the test for the Alzheimer’s gene, as a positive result could cause them great distress. And Hank Greely, JD, a lawyer and biomedical ethicist, said the genotyping test in general could be misleading, anxiety-provoking and counter-productive.

Nonetheless, 33 of the 54 students went ahead the next day and had their genotyping done (those I talked to, however, did not opt for the Alzheimer’s test). I interviewed several students at length about their experiences. One who showed me his genotyping profile said he was very reluctant to learn his Parkinson’s results; his father had recently died of the disease, and his grief was still fresh. I later asked him more about this issue; ultimately we agreed that I could write about his feelings but that he should remain anonymous, for the information he gave me was very personal.

In general, I was impressed at how thoughtful the students were in their approach to genomics and how it was going to affect medical practice - and their own lives. I found them somewhat intimidating; these are an extraordinarily bright and gifted group. All the students I interviewed felt the class had been extremely useful and that they felt much better prepared to help others interpret the cascade of data that is sure to emerge as genotyping - and eventually whole genome sequencing - become more available and widely applied.

Previously: Stanford TA weighs in on what students learned by being genotyped, Stanford students discuss studying their own genotypes and Genotype testing for medical, graduate students

Li Ka-shing, the leading Hong Kong businessman and philanthropist, recently shared with me the story of why he chose to help fund a new medical education building at Stanford that bears his name:

Stanford has always had a very special place in my heart. This is our third major project with the university, and each one reminds me of the time I brought my oldest son, Victor, to the campus to begin his education here many years ago. As we walked together past these beautiful buildings, I was overtaken by everything this university represents and the opportunities it provides for students. On that occasion, I remember looking at Victor and saying, ‘This is the first time in my life that I feel jealous.’

Mr. Li’s own education was cut short by the war in China, and he called that “one of the voids in my life that has never been adequately filled.” It gave him a hunger for learning and a commitment to invest in the learning of others, he said. The Li Ka Shing Foundation has granted more than $1.45 billion to projects worldwide, many of them in education.

Mr. Li came from Hong Kong to Stanford for ceremonies today to dedicate the new building, known as the Li Ka Shing Center for Learning and Knowledge. The five-level, soaring red-roofed center is the medical school’s first new education building in 50 years and is a model of innovation, with a ground floor simulation center that is among the largest in the world. It has a fully simulated hospital, complete with an operating room, emergency room and scrub rooms. Learners can use lifelike, programmable mannequins that bleed, breathe, blink and talk to test their skills in managing virtually any medical condition.

The building also has a high-end video capture system that can be used for an endless number of creative teaching techniques, such as transferring images of a training session with the mannequins in the basement up to the conference center on the second floor or eventually for instantaneous broadcast on the web.

Previously: Stanford building houses one of world’s largest medical simulation facilities and A new era in education at Stanford’s medical school
Photo by Norbert von der Groeben