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Interview with Study Investigator Andrea Savarino MD. "New HIV Cure Drug Combination Study - Drug-free remission of AIDS in monkeys: from anecdotal reports towards a globally scalable strategy" - "Investigational treatment suspension and enhanced cell-mediated immunity at rebound followed by drug-free remission of simian AIDS"
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New HIV Cure Combination Drug Study - (07/16/13)
Interview by Jules Levin with Andrea Savarino, MD, the principal investigator of this research study
Question #1- Jules: can you explain the reasons for the design, the costs and the parameters for this study and the limitations, why so few monkeys were studied:
Dr Savarino:
Entire cost of the study:
1 million dollar. This is due to the length of the study. I wanted to prove long term control in order to provide real chances for a significant improvement over ART for life. People go on asking this question without considering that ONLY big pharmas can proceed with higher numbers for this kind of study. So far the studies that they did failed, and no similar control was obtained from the higher numbers treated, as far as I know.
Question #2 - Jules: Can you discuss briefly the responses you observed by the macaques-
Dr Savarino:
The macaques that have been subjected to the same treatment respond exactly in the same peculiar manner (100% response), despite the differences in sex, age, MHC, starting viral load, viral load measurement technique and CD4 counts. Such a striking similarity is very unlikely to be a coincidence. The viral set point that I added is conservative due to a referee's request and refers only to the initial period of the follow-up. For example, macaque 4890 started from a viral load of 20 million copies/ml (i.e. ten times higher than the average viral loads of patients with full blown AIDS) and displayed in the last 200 days of follow up after therapy suspension an average viral load of 2.6, i.e. a decrease of almost 5 Logs.
Question #3 - Why is your study small, only a few macaques:
Dr Savarino:
The Berlin patient is one. The Boston patients are two. People are not yet used to these types of studies and think as though they were reading about a vaccination study in which high numbers need to be enrolled in order to exclude spontaneous control of the infection in some subjects.
Spontaneous control of the infection only occurs during or immediately after the acute infection phase, that is to say, either the infection is controlled soon or is controlled nevermore. Spontaneous healing of HIV or SIV infection in the advanced chronic phase has never happened in history. Therefore, such a radical change in disease progression cannot be evaluated only in terms of sheer numbers. If the old vaccine study-based mentality is maintained in the new HIV cure studies, then, this type of research will remain totally in the hands of big pharmas (which do not show to be currently producing brand new ideas on this topic).
It is the first time to my knowledge that a scalable therapy for inducing a functional cure in the advanced chronic phase of the disease yields such results.
Question #4 - You sound very excited about the study findings:
Dr Savarino:
Due to these reasons, yes, it was the most exciting finding of my life.
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