Take a pill regularly and it can decrease your risk of HIV risk by 90%. I feel like I’m dreaming- we have now entered a new age in the fight against HIV.
When FSG began our work with the Bill and Melinda Gates HIV team to set a five-year strategy 18 months ago, circumcision was the only new tool that had shown positive signs in clinical trials. The HIV vaccine field was languishing after years of negative results. Proponents of other biomedical interventions faced major challenges after many disappointing clinical trial results – so bad that some trials of microbicide gels reported harm to participants. Through our work on the cost effectiveness on the female condom with the Gates Foundation, we also are acutely aware that current technology is not sufficient to turn back the tide of the epidemic.
In the last year through a series of increasingly promising trial results the HIV field has turned around. Last fall the results from the RV144 HIV vaccine trial showed a glimmer of hope that a vaccine could have a protective effect. Then this summer at the AIDS 2010 conference in Vienna the CAPRISA 004 microbicide trial showed that a gel could prevent vaginal transmission of the virus. I’ve been waiting all fall for the results of the first clinical trial of Pre-Exposure Prophyllaxis, or PrEP, a promising approach of taking an anti-retroviral pill before exposure. Today’s news is a tremendous step forward, reporting 44% effectiveness in the trial population and an effectiveness of 90% in those who took pills regularly. One of the most remarkable aspects of the trial is that the pill (Truvada) is widely available for treatment now, and some physicians already prescribe it for prevention. It will have immediate impact.
For more details on the iPrEx study, start with the New York Times article, which includes a quote from FSG Global Health advisor Mitchell Warren Executive Director of AVAC. Mitchell is hosting a webinar with the clinical trial team tomorrow (Wednesday, November 20th at 9am).
While this is exciting for everyone in the field (and our client who contributed funding to the trial), there are some very tough discussions ahead.
- In a time of decreasing resources, when we aren’t even sure of how to fund our commitments to the 5 million people on treatment, and with millions still lacking treatment, how can we expand access to the uninfected?
- Will insurers pay for it in the US?
- How will we encourage greater adherence to push the effectiveness up closer to 90%?
- Will longer-acting forms of the drug be developed and will they improve compliance?
- How will we avert resistance to the drug, an important tool in treatment, as it is used more widely?
We’re thrilled to have played a very small role in the field to date, and recognize the tremendous amount of work ahead. What are your thoughts on the path ahead? What questions does this bring to mind for you?