By Mark Harrington
A cure for HIV is possible: one man, the so-called Berlin patient, has already been cured of chronic HIV infection with an immune system transplant with cells genetically resistant to HIV. After four years, the man remains free of detectable HIV, and his HIV antibodies are disappearing. However, this approach is dangerous (potentially fatal), costly, and not scalable to the 34 million people currently living with HIV.
A cure for HIV is necessary: 34 million people worldwide are living with HIV, and 25 million more will be infected in each of the coming decades (a total of 300 million by 2100). The lifelong treatment of these 334 million people would be logistically difficult, expensive, and could result in drug resistance, treatment failure, and onward transmission of drug-resistant HIV—a public health nightmare without end.
Five things are needed to cure HIV:
- Scientific commitment. The U.S. National Institutes of Health, the French National AIDS Research Agency, the Foundation for AIDS Research (amfAR), and a handful of drug companies including BMS, Gilead, Johnson & Johnson, Merck, and Sangamo are all committed to AIDS cure research; some of the smartest experienced and younger scientists are working tirelessly to discover and develop a safe, effective, feasible, and scalable HIV cure.
- Scientific resources. Curing HIV will require a massive investment of scientific resources including grant money, animal models, laboratory tests, and expensive and long-term clinical trials. Experts estimate that over $800 million a year will be needed to fully fund the most promising opportunities in AIDS cure research. Currently less than $100 million per year is available for this effort. Full funding for the NIH and its AIDS research budget, overseen and coordinated by the NIH Office of AIDS Research, will be necessary to achieve a cure for AIDS.
- An informed, educated, and motivated community of participants for HIV cure clinical trials. Currently, many people with HIV are interested in enrolling in cure-related clinical trials. However, to ensure their continued willingness to engage in studies that will be long-term, high-risk, and may involve deferring, interrupting, or going off highly effective antiretroviral therapy, continued community education, involvement, and participation in cure research at all levels (planning, implementation, evaluation, community outreach and education, resource mobilization, and advocacy) will be required.
- A flexible, rigorous, and inclusive regulatory approach to cure-related clinical trials. Just as the U.S. Food and Drug Administration (FDA)—after many activist demonstrations and interventions—created a flexible regulatory environment that allowed the rapid study of anti-HIV drugs, accelerated their approval based on changes in so-called surrogate markers such as CD4 cell counts and HIV-RNA levels (viral load), and expanded access to experimental agents for those lacking valid therapeutic options, so HIV cure research will require coordinated, flexible, and scientifically advanced regulatory oversight by the FDA working across departments involving drugs, therapeutic vaccines, monoclonal antibodies, and cell and gene therapies.
- Public understanding and commitment to curing AIDS. The HIV cure research effort will be long-term, high-risk, and will include many failed studies and approaches before it succeeds in discovering and delivering a safe, effective, feasible, and globally scalable HIV cure. Public support and understanding of this effort are essential to secure the research funding and political support that will be required for this effort to succeed.