E la presentazione, infine, ieri c'è stata. E per chi volesse maggiori particolari:Dora ha scritto:
LA FRAGOROSA DÉBÂCLE DEL RIVER TRIAL (e i rischi dell'hype)
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- [...] investigators found no difference in effect between those participants who received the active ‘kick and kill’ therapy and those who had standard treatment [...] - scriveva 'stanotte un articolo delle News dell'Imperial College London.
[...] To claim success in the RIVER proof of concept trial, the researchers said that those receiving the kick and kill drugs should experience a significant fall in levels of HIV in the reservoir cells, known as CD4 T cells.
However, when the results were first unveiled to researchers in April 2018, they found that the half of trial participants given the kick and kill drugs in addition to ART had similar levels of infected reservoir cells compared to those who only received standard ART therapy. [...]
RIVER Chief Investigator, Professor Sarah Fidler of Imperial College London said:
[...] Based on the findings, the study doctors have told participants that they cannot recommend that all study participants receive the kick and kill drugs as well as their ART and that the trial did not find evidence to recommend that any participants could safely stop taking their ART.[...]
- “In the RIVER study, we found that all the separate parts of the kick and kill approach worked as expected and were safe. The vaccine worked on the immune system, the kick drug behaved as we expected it to, and the ART worked in suppressing viral load in the body, but the study has shown that this particular set of treatments together didn’t add up to a potential cure for HIV, based on what we’ve seen so far.” [...]
Looking forward to possible next steps, the RIVER co-principal investigator and scientific lead, Professor John Frater of the University of Oxford said:
- “We need to think about why we didn’t see an effect. The important thing to realise is that despite these disappointing results, it does not mean that the basis of the approach is wrong. This is the very first randomised study of the ‘kick and kill’ concept in humans and the field now needs to work together to explore how better and more effective agents can have an impact on the HIV reservoir while remaining safe.
“It is possible that the combinations of drugs we used weren’t quite right, but for this first study we didn’t want to compromise on safety by using stronger agents that might work better but could cause toxicity to the participants. It is possible that vorinostat was not quite potent enough to wake up as much HIV as was needed for the newly trained immune system to recognise. Equally, it is possible that a different sort of immune response to the one we induced is needed to target the HIV reservoir. All of these possibilities need to be teased out and considered to guide our next move in searching for an HIV cure.” [...]
Direi che, con dichiarazioni così ad ammettere senza possibilità di dubbio il fallimento del trial, non c'è neppure bisogno di aspettare la presentazione di A randomised controlled trial comparing the impact of antiretroviral therapy (ART) with a 'Kick-and-Kill' approach to ART alone on HIV reservoirs in individuals with primary HIV infection (PHI); RIVER trial oggi ad Amsterdam.
Solo una mesta considerazione: professori Sarah Fidler e John Frater, dopo aver assistito al fiasco dei danesi con il panobinostat, valeva proprio la pena creare tutto quell'hype spaventoso sulla stampa quando - di fatto e come sommessamente vi fu ricordato subito - in mano non avevate niente di niente?
Considerazione #2: con lo stesso vaccino terapeutico, ma usando la romidepsina invece del vorinostat, sempre in persone che avevano iniziato la ART in fase acuta, Beatriz Mothe e collaboratori spagnoli hanno invece portato a casa dei risultati assai più incoraggianti - come raccontarono al CROI 2017.
Non è che questa disastrosa débâcle del RIVER trial dovrebbe indurre a qualche seria (e mestissima) riflessione sul vorinostat, professoressa Daria Hazuda (e Sharon Lewin, anche)?
- Natap pubblica le slides e, in mezzo a una certa fuffa auto-assolutoria che mi ha ricordato la strategia di Barbara Ensoli di affannoso affastellare marker su marker totalmente ininteressanti per mascherare il vuoto di risultati concreti, le più interessanti e fondamentalmente oneste delle diapositive a mio parere sono queste:
