An international clinical trial involving nearly 5,000 people with HIV confirms that treatment with antiviral drugs should start as early as possible after diagnosis. In fact, the results were so dramatic that the study was cut short nearly a year early so that all participants in the trial could receive the drugs.
Participants in the Strategic Timing of AntiRetroviral Treatment, or START, trial who initiated treatment when their immune system was still strong were half as likely to die or develop a serious illness compared with those who delayed treatment until their immune systems had been weakened by the human immunodeficiency virus, according to a news release from the National Institutes of Health.
The results are likely to have major implications for the use of antiretroviral drugs, a major advance in HIV treatment that has allowed many HIV-positive individuals to live long and healthy lives. The drugs cannot cure patients but they keep the virus suppressed so that it doesn’t damage the body and so that patients are much less likely to infect someone else.
U.S. guidelines already call for early treatment of patients with HIV, but some global health experts have been hesitant to recommend prescribing antiretroviral drugs too early. While several epidemiological studies have shown that starting therapy sooner leads to better patient outcomes, concerns lingered about the potential for serious side effects from being on antiretroviral drugs for a lifetime. Additionally, some experts have expressed concern that patients might not always take the drugs regularly, which can give the virus an opportunity to mutate into drug-resistant forms.
The START study, which has been tracking more than 4,600 HIV-positive people in dozens of countries since 2011, aimed to figure out whether it was better to start antiretroviral therapy immediately, when HIV patients are still relatively healthy, or wait until their white blood cell count drops below a certain point. The lower a patient’s white blood cell count, the more likely he or she is to progress to AIDS.
The clinical trial, which was initially scheduled to conclude at the end of 2016, randomly assigned participants to early and later treatment groups, based on their white blood cell counts. The results were dramatic: Among the HIV-positive people who received early treatment, the risk of dying or developing a serious illness was reduced by 53 percent. For AIDS-related illnesses in particular, the risk reduction was even more pronounced at 70 percent.
These benefits were seen in study participants from all parts of the world, and the results held up regardless of whether people lived in low-income, middle-income or high-income countries. Early therapy also helped reduce the spread of HIV from infected individuals to their uninfected partners.
The findings were so compelling, the researchers said, that it would have been unethical to continue the trial for another year. Instead, they’re ending it now and giving all of the participants immediate access to antiretroviral drugs.
“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” Dr. Anthony Fauci, the director of NIH’s National Institute of Allergy and Infectious Diseases, which funded most of the research, said in a statement. “Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others.”
“These findings have global implications for the treatment of HIV,” he said.
Indeed, the results may have a demonstrable impact on the estimated 35 million people worldwide living with the virus. While the U.S. guidelines back treatment regardless of patients’ white blood cell counts, the World Health Organization’s guidelines recommend that HIV-infected people should begin treatment only when their white blood cell count falls below a certain threshold. These new findings could spur the international community to endorse treatment for everyone diagnosed with the virus –a move that the United Nations’ AIDS agency made after the study’s results were publicized.
“Every person living with HIV should have immediate access to life-saving antiretroviral therapy,” Michel Sidibé, the executive director of UNAIDS, said in a statement. “Delaying access to HIV treatment under any pretext is denying the right to health.”
While the findings are still considered preliminary, they provide the most compelling evidence so far that the potential side effects of the drugs are not serious enough — and the benefits to patients’ personal health are too great — to justify delaying treatment, even for people who still appear to be healthy. Dr. Jens Lundgren of the University of Copenhagen, who helped sponsor the START study, called it “an important milestone in HIV research.”
Of course, even if global guidelines call for immediate provision of treatment, not everyone with HIV will have access to the life-saving drugs. Although a record 13 million people accessed antiretroviral treatment in 2013, about 22 million other people living with HIV are not accessing treatment. In low- and middle-income countries, just 1 in 3 HIV-positive adults have access to treatment. Even in the U.S., many people don’t seek or stick with early care: The Centers for Disease Control and Prevention recently reported that only about 30 percent of Americans with HIV have the virus under control. The global health community is continuing to work toward universal access to HIV treatment, but even with recent drops in the price of antiretroviral drugs, cost issues remain a challenge.
Access to treatment is also hindered by HIV-related stigma and discrimination, which, in many countries, is codified by law. According to a 2013 report by UNAIDS, 60 percent of countries have laws, regulations or policies which present obstacles to providing effective HIV prevention, treatment, care and support. That figure includes, among others, 78 countries where homosexuality is considered a crime, 63 countries where HIV transmission or exposure is a prosecutable offense, and 116 countries where sex work is criminalized.
The WHO cites fear of stigma and discrimination as the main reason why people are reluctant to get tested, disclose their HIV status and take antiretroviral drugs. In one study in Chicago, a staggering 50 percent of HIV-positive youth reported skipping doses of their antiretrovirals because they feared family or friends would discover their status. In another study, researchers found that people who experienced high levels of HIV-related stigma were over four times more likely to report poor access to care.
Thirty years ago, a diagnosis of HIV was tantamount to a death sentence. Between 1988–1995 a staggering 78 percent of people infected with the virus died from causes directly attributable to AIDS. Today, that number is about 5 percent — a drop that is attributed to advances in antiretroviral therapy. Still, an estimated 1.7 million people die each year because of disparities in access to these life-saving drugs.