Dr. Deborah Donnell, a biostatistician at Fred Hutchinson Cancer Research Center, today was named a Fellow of the American Association for the Advancement of Science.
The honor, a mark of distinction from the AAAS, hails Donnell for her contributions to science in a field where she plays a pivotal role in analyzing results of clinical trials of drugs that can prevent HIV infection.
Fred Hutch epidemiologist Dr. Elizabeth Halloran, who was named an AAAS Fellow in 2009 and is a member of the National Academy of Medicine, said Donnell “has been lead statistician for major studies that have changed the international field of HIV prevention.”
“Dr. Donnell led these efforts with her rigor and expertise,” added Halloran, who heads the Hutch’s Biostatistics, Bioinformatics and Epidemiology Program.
“I think it’s always lovely to have the recognition,” said Donnell, who has more than 25 years of experience in the design of HIV prevention trials.
“Particularly in statistics, you are very often more of a background worker. We are the people who make sure the science is solid and replicable,” she said.
Although Donnell works at Fred Hutch in Seattle, her primary job is as principal investigator for statistical and data management for the HIV Prevention Trials Network, or HPTN, a clinical trials network funded by the National Institutes of Health. With leadership based in North Carolina and New York, it is best known for trials of antiviral drugs meant to block HIV transmission. It collaborates closely with the Hutch-headquartered HIV Vaccine Trials Network, or HVTN, which is the world’s largest independent collaboration focused on HIV/AIDS vaccines.
Most recently, Donnell’s group led the statistical analysis that this month found cabotegravir, a drug that can prevent HIV infection with shots given every two months, was nearly 90% more effective than a daily antiviral pill, Truvada, in protecting African women against the virus that causes AIDS.
“It is a really important result for women,” she said. “We’ve always had this gap in HIV prevention for women, because in spite of evidence that a daily pill prevents HIV in young sub-Saharan African women, there were real challenges in adherence to that regimen.”
The landmark study known as HPTN 084 was halted by the study’s independent Data and Safety Monitoring Board after an early look at the data generated among 3,223 women showed the results were so good they could be released early. The injections were nearly nine times as effective at blocking HIV infection as were daily doses of Truvada, a pre-exposure prophylaxis, or PrEP, pill formulated from the same antiretroviral medications used to treat HIV.
— Dr. Deborah Donnell
While an earlier study this year had shown cabotegravir was also better than Truvada in preventing HIV among men, women in Africa have not benefited from the same level of protection from that drug. There is some evidence that, biologically, Truvada is not as effective in women, and in sub-Saharan Africa there are complex socioeconomic barriers and stigma that make it difficult for women to take the pills every day. The latest results could mark a dramatic shift in giving adolescent girls and young women — who bear the brunt of HIV infection in the region — a significant level of protection absent a vaccine.
“It’s an opportunity to leapfrog forward in terms of really preventing women from getting HIV,” Donnell said. “In the trial itself, women were very successful in coming in and getting the injection every eight weeks, which is why we had this enormous difference.”
The recent clinical trials of injectable, long-lasting antivirals to prevent HIV are only the latest of a series of landmark studies for which Donnell or her Hutch-based group led the statistical analyses.
In 2008, the HPTN launched a clinical trial, HPTN 052, the first to prove conclusively that antiviral drugs designed to treat HIV infection could also prevent it. The study enrolled “serodiscordant couples” — where one partner is HIV-negative and the other HIV-positive — and provided antivirals to the HIV-negative partner. After the results three years later revealed that the drugs reduced heterosexual transmission by 96%, Science magazine named the trial as its 2011 Breakthrough of the Year.
Another clinical trial in which Donnell wrangled the data is known as the Partners PrEP study. In 2012 it was the first to show that a daily dose of Truvada was 75% effective in preventing infection among serodiscordant couples — establishing PrEP as an effective tool in HIV prevention. It was the first of several trials that eventually showed that consistent use of the drug was up to 99% effective in preventing HIV among gay men.
“I’ve had more than my share of successful trials,” Donnell said. “Most of these are once-in-a-lifetime opportunities. I’ve had three or four. I’ve been lucky.”
Statistics and number-crunching may lack the glamor of laboratory drug discovery or vaccine research in remote parts of the world, but Donnell has taken great pleasure in the work that is central to her field.
“Statistics is enormously satisfying, in the same way math is enormously satisfying to solve problems and to demonstrate the meaning of the numbers,” she said. “It’s something I just love doing.”
Sabin Russell is a former staff writer at Fred Hutchinson Cancer Center. For two decades he covered medical science, global health and health care economics for the San Francisco Chronicle, and he wrote extensively about infectious diseases, including HIV/AIDS. He was a Knight Science Journalism Fellow at MIT and a freelance writer for the New York Times and Health Affairs.