The results of the HPTN Study 052 — which randomized 1,763 serodiscordant couples to early vs delayed ART to evaluate whether this reduced the risk of HIV transmission — have just been released:
Findings from the study were reviewed by an independent Data and Safety Monitoring Board (DSMB) …The DSMB concluded that initiation of ART by HIV-infected individuals substantially protected their HIV uninfected sexual partners from acquiring HIV infection, with a 96 percent reduction in risk of HIV transmission… Among the 877 couples in the delayed ART group, 27 HIV transmissions occurred. This was in contrast to only one (1) transmission that occurred in the immediate ART group. This difference was highly statistically significant.
Full details from the study are of course not yet available, but here are some reasons why the results, if not surprising, are so important, and why this is a huge win for earlier antiretroviral therapy:
- The protective effect (96%) was every bit as good as that reported in non-randomized studies (such as this one).
- Since the study only enrolled patients who were asymptomatic with high CD4 cell counts (350-550), study subjects were generally those at the lowest risk of transmitting HIV to others — yet a significant difference in transmission was still observed. One could have imagined the study being negative due to low event rates, and indeed the relative health of the population is at least a partial explanation for how rare transmission was even in the delayed therapy arm.
- Details about the one case of transmission — yes, only one! — that occurred from someone on ART will be important, such as whether the plasma HIV RNA was undetectable, his/her level of adherence, transmission of resistant virus, etc.
- There were clinical benefits to early ART as well, with a significant reduction in the incidence of extrapulmonary tuberculosis — 17 vs 3 cases in the delayed vs early ART arms respectively.
- Note that survival was not different — a factor likely related to #2 above, and something for us to consider when anticipating results of the START trial.
We of course await information on adverse effects, quality of life, resistance, and cost, but it’s hard to imagine that any of these factors would be of sufficient severity to negate the obvious personal and public health benefits of early ART. In fact, I’ll go out on a limb and predict that they won’t even come close.
And I’ll also express the view that this result is far more important than the PrEP studies, since it’s always made way more sense to me to treat the person with HIV, not the other way around. PrEP may have a small role in reducing the spread of HIV — especially in certain very high-risk individuals — but is unlikely ever to be widely adopted.
So treatment is prevention. Now we just have to figure out how to pay for it.
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FROM NEJM — Recent Infectious Disease Articles
Setting aside issues of diagnosis and treatment compliance these findings could be of great significance for sub-Saharan Africa: an intervention that is here now and ready to use, albeit requiring roll out on a massive scale. Math-mo’s, get your calculators at the ready and give us a 20 year cost benefit analysis!
Ed I couldn’t agree more. Since ART is generally cost-effective, if one adds this benefit (reduction of transmission), it will likely up the cost effectiveness substantially.
I agree with yours comments and like Ed I think it can have a major impact on HIV prevention.
Would consider that to be able to start early treatment, we need to think not only on the costs related to treatment, but as you well mentioned, adherence and acceptance. There could be a mistake thinking that it will be better accepted than other prevention measures, such as condom use and it could get to be the opposite, especially in certain countries in Africa. Acceptance of the population directly affected is the key to any success, however small it may be.
On the other hand, an early treatment requires an early diagnosis and in many European countries we see how difficult is obtain a reduction of missed opportunities for early diagnosis (for example, the lack of a mechanism to do a serology in patients who come through the emergency room with other STD (syphilis, etc)).
Thanks a lot!!!
Thumbs up to the research team and study participants. This moves us to another step in HIV prevention. But as noted many time, taking Uganda as an example; one study showed that 76% of the participants were not aware of their HIV status. Thanks to those working around the clock to ensure HCT services reach every one, but a lot is still desired. The story makes us more sad, when many people are kept on septrine for years because of limited capacity to handle the HAART costs.
In my view, the planners should think about re-adjusting the budgets, Prevention has been on top without the inclusion of treatment, since it is proved to do magic, then it should be given priority in the budget. However, all other strategies should continue so that we dont divert and give this enemy way to conquer us again.
Thanks for the good work done once again.