Diary Prequel Package — page 464

July 8, 2015 -- Attended the joimt NIH/Gates meeting at the Porter Neuroscience Building (Building 35A). Had good discussions with the Gates people about Ebola response, discussing clinical trials for therapy and vaccine. Peter Hull is a solid gates person (used to be with Novartis). Extremely muggy day in DC with intermittent showers. We have had heat followed by showers for many days in a row. Visited the White House West Wing at 3:00 PM to meet with Doug Brooks and Valerie Jarrett. Ran into Denis McDonough, Lisa Monaco and Jack Lew in the West Wing Lobby. Purpose of meeting with Valerie was that I want to convince her to consider advising the POTUS to take on the potential legacy issue of ending HIV/AIDS in the USA. Iexplained to Valerie the recent data on treatment as prevention, and the START study showing early ART is much better than delayed ART for the person getting treated (53% fewer events). This complements the finding from HPTN-052 that early treatment is beneficial to the uninfected sexual partner since it decreases transmission from infected to uninfected partner by 96 percent. Also, discussed the high efficacy of PrEP when taken regularly. Valerie was very pleases with the meeting and said that she would help and bring it up to the POTUS. I do not expect at all that there will be additional money for this. As with the initiation of PEPFAR by me and the early conversations that I had in 2002 with Josh Bolton, I did not ask for anything for NIH; I actually said that the major implementer would likely be CDC, NAPO with me as the "thought leader" and advisor or consultant. She asked Doug to put together a proposal, which Doug would run by me. Before I went into the West Wing, Marie-Paul Kieny called me on my cell and informed ime that the ring vaccination trial that WHO was conducting in Guinea has a positive result with 11 infections in the delayed ring and 0 infections in the immediate ring (P= 0.043). They will stop the study and they already are writing the paper to be published in Lancet. Very interesting since Cliff and I have been insisting that the only real way to go with a vaccine trial is with an RCT with a placebo. My feeling is that this is still the case. However, if you have a vaccine that is close to 100 percent effective, it really does not matter if the trial design is suboptimal. In any event, thank goodness we have a vaccine now for Ebola. Issues now are how and where to deploy it. The vaccine is the VSV from New Link/Merck. Remember, we did the Phase 1 on this vaccine at the Clinical Center. Also. I put her in contact with Bill Dahut (Clinical Director, NCI) to see if we can give her the infusions of monoclonal antibodies here at NIH under the direction of Ken Anderson.