January 1, 2017
Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.
A lot of these "Best of ..." or "Top Stories in ..." lists have already been published, as they seem to be appearing earlier and earlier each year. Pretty soon we'll start reading them around the same time they sell Halloween Candy -- and that's just too early, sorry.
Now this list, however, appears just as 2016 is in the books, all 365 days accounted for and scrupulously reviewed. And I chose five because, well, five follows the rules.
(I just finished a block on service and can't resist linking that post, since the rules came up literally every day.)
Of course by choosing only 5, I've necessarily had to leave off some big HIV stories this year in research, clinical care, or policy, so feel free to enter your top story in the comments section.
Drum roll, please.
With approval this year of co-formulated TAF/FTC, we now have the ideal NRTI pair to use in treatment of, well, pretty much everyone. Yes, we already had TAF/FTC as part of the single tablet treatments of TAF/FTC/RPV and TAF/FTC/EVG/c, but those aren't appropriate for all patients -- both must be taken with food, RPV has high viral load and low CD4 restrictions, and EVG/c has a long list of drug interactions. The availability of TAF/FTC provides greater flexibility when, for example, you want to use it with a different 3rd drug -- dolutegravir, or raltegravir, or yes even efavirenz -- or as part of a more complex salvage regimen, where it's generally given with DRV/r.
Admittedly, we're still stuck on 1 person cured -- the famous Timothy Ray Brown, he of the CCR5-negative stem cell transplant (and cute dog). But that "n of 1" has led to extensive pre-clinical and clinical research on HIV cure, with lots of very smart people working on the problem. Here's one notable (and surprising) example -- antibodies directed against alpha4/beta7 integrin given to SIV-infected primates led to sustained viral suppression after stopping ART. This finding led to rapid initiation of a human study at the NIH using the drug anti-alpha4/beta7 drug vedolizumab, which is already approved by FDA. One caveat on all this research -- HIV cure studies are notorious click-bait, as demonstrated here.
It's called HVTN 702, and it will enroll 5400 seronegative people in South Africa, arguably the country in greatest need of an HIV vaccine. Participants will be randomized to receive either placebo or a vaccine series modeled after the RV144 clinical trial in Thailand. The HVTN 702 strategy, however, modifies the vaccine to provide greater and more sustained immunogenecity than RV144, and has been further adapted to the HIV subtype that predominates in southern Africa. Fingers crossed!
When TDF/FTC for pre-exposure prophylaxis (PrEP) was approved in 2012, I thought it was going to remain a niche intervention, rarely requested by patients or ordered by clinicians. However, since the presentation of the PROUD and IPERGAY studies in early 2014, and the release of guidelines by the CDC, use of PrEP has taken off -- around 80,000 people in the USA are now receiving PrEP, a more than 700% increase since 2012. Most of the use, not surprisingly, is in MSM from affluent urban areas. Two cautionary notes: First, the highest risk patients -- young MSM of color, especially in the south -- aren't getting it nearly enough; second, PrEP isn't perfect, with two failures (here and here) despite good adherence, likely due to transmission of NRTI-resistant strains.
Did I make that clear enough? Publication of two major papers proved this point: 1) The final results of HPTN 052 showed ZERO transmissions from an HIV-infected study subject to his seronegative partner if the blood HIV RNA was undetectable, and; 2) The PARTNERS study, which explicitly recruited serodiscordant couples not using condoms, again demonstrated ZERO transmissions. We all thought that ART would be effective in preventing HIV transmission -- but the degree of protection is way beyond what any of us could have hoped. It's this effect that's probably leading to a decline in new HIV diagnoses in certain major cities that have a high proportion of patients on treatment, such as San Francisco, New York, and London.
Happy New Year, everyone!
And in honor of the setting for HVTN 702 (see #3 above), here's 2016's most popular Youtube video in South Africa.
(Thanks to NPR.org for the video reference.)
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