Frequently Asked Questions: The Road to an HIV Cure

On Oct. 2, 2014 Italian researchers published a new report in The Lancet that found a second baby who was treated for HIV and thought to have been “cured,” has again tested positive for the virus. The baby boy, born to a HIV-positive mother in 2009 in Milan, Italy, began receiving aggressive antiretroviral therapy (ART) within 12 hours of his birth and remained on ART until age 3, when doctors decided to suspend treatment. One week after stopping treatment, the child still appeared to be cured, but two weeks later the child's viral load rebounded and the team restarted him on ART. By the third week, the boy's his viral load appeared to be under control and fell to low levels, but he continued to test positive for HIV.

This news comes a few months after the July 10, 2014 announcement from the U.S. National Institutes of Health (NIH) that the “Mississippi baby,” believed to have been functionally cured of HIV, was also found to have detectable levels of the virus.

At the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), we are disappointed by these setbacks but remain hopeful that the scientific breakthrough that allowed the Mississippi baby’s HIV levels to remain undetectable for more than two years will continue to help researchers understand how to control HIV and ultimately develop a cure.

Read on to learn more about the scientific research and medical treatments that led scientists to believe the Mississippi baby had been functionally cured and what these findings mean for future research initiatives to explore outcomes in other children, such as the “Long Beach baby,” who have also shown signs of being functionally cured.

What is EGPAF's position on these findings?

The “Mississippi baby” represents an unprecedented immune system response to HIV and demonstrates that very early treatment can significantly affect the reservoir levels of HIV in the body, even if it doesn’t fully eliminate the virus. We strongly support the clinical trials and continued research being led by the NIH, the Johns Hopkins University, and the other institutions involved in this study, as well as the many other studies that are currently searching for an HIV cure.

EGPAF supports efforts to end AIDS in children through prevention of mother-to-child transmission (PMTCT) services. Globally, 700 babies are newly infected with HIV every single day. Almost all of these babies contract the virus from their mothers during pregnancy, child birth, or breastfeeding. Research has shown that these infants need both early HIV diagnosis and ART as soon as possible in order to survive.

We have the tools available now to stop mothers from passing the virus to their babies and will continue our efforts to support PMTCT programs worldwide. However, we must expand access to diagnosis, treatment and prevention measures in order to create a generation free of HIV and AIDS.
 

What do these findings mean for the effort to achieve an AIDS-free generation?

We must take a multi-pronged approach to ending AIDS in children. We are making great strides toward eliminating mother-to-child transmission of HIV globally. By providing a pregnant or breastfeeding woman antiretroviral therapy (ART) we can almost completely eliminate the possibility that she will pass the virus onto her baby during pregnancy, child birth, or breastfeeding.

We are also working diligently to expand access to treatment for the 3.3 million children worldwide who are living with HIV to ensure that these children are able to lead healthy lives. 

Despite this latest setback, the viral suppression represented in both the "Long Beach baby" and the "Mississippi baby" cases bring fresh hope that new research and treatment options will provide us with even more ways to end AIDS in children and to achieve an AIDS-free generation.

Why did scientists think the "Mississippi baby" was potentially cured of HIV?

The “Mississippi baby” was born to an HIV-positive mother who was not aware of her status until she gave birth. The child was given ART within hours of birth and was later found to show no signs of the virus. She stopped receiving ART at 18 months of age and continued to show no evidence of HIV until July 2014 when it was revealed that she now has detectable, low levels of HIV.

More research will need to be done to understand the long-term implications of this finding for the “Mississippi baby” and other children who have been given similar treatment.

Was this method also used in "Long Beach baby" and others?

The “Long Beach baby” was born in Long Beach, CA in April 2013 to an HIV-positive mother. She was diagnosed with HIV immediately after birth. While the mother was aware of her HIV status, she was not taking the prescribed medications and the level of HIV in her blood was very high, increasing the risk of transmission to her baby.

The pediatricians responsible for the infant's care took early action against the virus, giving her ART within four hours after her birth. The baby girl currently shows no sign of the virus and remains on ART.

The Milan baby's treatment was intentionally suspended by doctors and when signs of HIV re-emerged, he was put back on ART. 

There have also been recent announcements that doctors in Canada have administered the same treatment to three additional infants, who have shown evidence of a functional cure.

What is a functional cure?

A functional cure means that there is no sign of HIV, even after medication has been suspended. HIV may still exist in extremely small amounts, necessitating long term follow-up to ensure that the virus doesn’t return to high levels.

The difference between the “Mississippi baby” and the “Long Beach baby” is that the "Mississippi Baby" stopped receiving ART after 18 months because her mother didn’t return to the clinic for treatment.

The “Long Beach baby” remains on medication. In order to determine if she has also been functionally cured, her doctors must eventually suspend her medication to see if a functional cure has been achieved. When ART is stopped, the baby will be closely monitored and ART would be immediately resumed if HIV is detected.

Was EGPAF involved in treating the "Long Beach baby" or the "Mississippi baby?"

Deborah Persaud, M.D. and Katherine Luzuriaga, M.D., two of the leading researchers examining the effectiveness of this method, received the Elizabeth Glaser Scientist Award in 2005 and 1997, respectively. While EGPAF was not directly involved in this latest research, we strongly support efforts to treat and prevent HIV around the world.

Through investment and collaboration with scientists, local health care providers, and key stakeholders, EGPAF is creating scientific evidence to prevent, treat, and cure HIV in children and families.

How does this breakthrough impact EGPAF's current research efforts?

We began as an organization that identified and funded much-needed research for pediatric AIDS, and the research we do today continues to change the future for children, their families, and their countries. In fact, partly due to these encouraging results, we have embarked on an initiative to create a Pediatric HIV Cure Consortium to raise funds to support the critical pediatric cure-focused research.

We are not only fighting AIDS, we are changing the way the world fights AIDS. We work hand-in-hand with governments, partners, research institutions, mothers, families, and donors toward a health and social infrastructure that can end HIV/AIDS.

Will this method work on other HIV-positive babies?

An NIH clinical trial is still set to begin in the summer of 2014 to study 60 infants infected with HIV at birth to explore the concept of HIV remission that could lead to the development of a cure. The infants will be given a similar ART regimen within 48 hours of birth. It will take several years to determine if this method or any other current research studies dedicated to finding an HIV cure will be effective and be able to be administered on a larger scale.

If this method proves successful during the clinical trials, pediatric treatment guidelines will likely change to recommend this new method of treatment for infants. More research and clinical trials will be needed to find a cure for HIV-positive children and adults.

Would this treatment work on adults?

Probably not — most adults living with HIV don’t become aware of their status for many months or even years after they become infected. By the time they are diagnosed, the virus has been replicating in their bodies and the infection can’t be eliminated using ART.

Babies are usually infected with HIV during pregnancy, childbirth, or breastfeeding. This new research suggests that if  the baby is treated immediately, the virus can be prevented from spreading throughout the body. Research also suggests that very early treatment of adults after HIV infection may result in keeping virus levels very low for long period of time.

What is the timeline for making this potential cure method more widely available?

We are most likely several years away from finding a cure for HIV for infants, children, adolescents, or adults. Several clinical trials must take place before researchers can determine if this, or any other method, is effective and can be used on a wider scale.

Will this method work in resource-limited settings, such as the 13 countries in Africa that EGPAF supports?

More research will be needed to determine how this method, if found to be effective in clinical trials, can be used on a global scale. Access to care remains a challenge and therefore any new treatment or cure-related methods will take years to implement.

Currently pediatric treatment lags significantly behind adults—only 34% of eligible HIV-positive children have access to ART. At EGPAF, we are working diligently to expand access to pediatric HIV care and treatment services worldwide.

What is EGPAF currently doing to eliminate pediatric HIV?

Currently, EGPAF’s programs focus on prevention as the best tool to end pediatric HIV. We have provided more than 20 million women with services to prevent them from transmitting HIV to their babies.

We are making a lasting difference for mothers, families and children. Our job isn’t over until no child has AIDS. This means giving families, communities, and countries the tools and resources they need to plan, implement, and sustain their HIV programs so that all families can access these services.

We know that the elimination of pediatric HIV/AIDS cannot be achieved and sustained without strong health systems. Therefore, we support effective local leadership at the national, subnational, and community levels. This is critical to ensuring a viable and efficient health system that can end pediatric AIDS and improve the overall health of women, children, and their families.

If a potential cure for HIV is around the corner, can other people living with HIV stop taking their medications?

No. We are still many years away from being able to cure HIV infection in adults or children. Adhering to ART regimens is the best and most effective way for people living with HIV to remain healthy and prevent them from passing the virus to others, including their children or sexual partners.

Is a cure different from an HIV vaccine, and is an HIV vaccine currently in development?

A cure for HIV, and the work to develop one, is different from efforts to develop an HIV vaccine. A cure would be used to eliminate HIV from the bodies of people who are already infected with the virus. A vaccine would be used to prevent people who are not HIV-positive from becoming infected. 

There are several research institutions around the world working to develop an HIV vaccine, which will be essential to ending this epidemic. An effective vaccine to immunize against HIV would need to be usable in a variety of settings and for people of all ages.

Why is it so important to find a cure for HIV/AIDS?

HIV/AIDS has killed more than 36 million people since the epidemic began in the 1980s. It is one of the greatest global health threats of our time. Currently 35 million people are living with the virus and 3.3 million of them are children younger than 15. Without medication, more than half of all children living with HIV will die before the age of 2 and 80 percent will die before their fifth birthday.

Of those infected, only approximately 9.7 million people are currently on ART. Even if we could stop new infections with a vaccine or other highly effective prevention intervention today, there would still be more than 35 million people who need ART and other services for the rest of their lives. Being able to cure people of their HIV infection would, over time, reduce the number of people living with HIV and thereby reduce the individual and societal burden of ART and other care and treatment of HIV infection.

At EGPAF, we are committed to supporting the programs, research, and advocacy efforts needed to end this epidemic and we will continue our work until no child has AIDS.