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Announcement plugging ‘encouraging’ safety trial on HIV drug doesn’t include any safety results

Rating

3 Star

Encouraging clinical results for an antibody drug to prevent or treat HIV

Our Review Summary

While this study of a clinical trial of a new biologic agent called 10-1074 is understandably exciting for HIV researchers — it involved just 33 people (19 individuals who were infected with HIV and 14 who were not) — and lacked important detail which would have made it more meaningful for the rest of us.

We give the release credit for acknowledging that the biologic drug is still preliminary and needs to be tested in a larger trial, but that caution seems overshadowed by the other premature projections made in the release.

The stated purpose of the research was “to determine whether the antibody was safe and whether it had antiviral activity in humans” but the news release didn’t tell us the actual results of the trial and what this might mean in the larger context of HIV treatment.

 

Why This Matters

We know that antiretrovirals — the current therapy  — can cause severe side effects and require lifelong treatment. But highlighting a new approach without talking about its potential drawbacks seems to be premature. We hope that “broadly’ neutralizing antibodies is part of an alternate treatment strategy, but without more detail, is it too soon to be getting HIV-infected patients hopes up?

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

This new process sounds very expensive but the release doesn’t give us any clues as to how costly it might be. Biologic therapies used for other indications are very expensive. It would be helpful if the release had at least mentioned cost, even to say that they are as yet unknown.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release could do a better job of explaining that this is a very limited study looking primarily at safety. There are no meaningful clinical outcomes reported.

When the release states “among 13 HIV-infected people who received the highest dose of 10-1074, 11 showed a rapid decline in the amount of virus” — we need to know what that means. What is rapidity and how is it important? Is it relevant to patients that the trial drug was “sensitive to other broadly neutralizing antibodies, including 3BNC117?” What does this mean?

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t include a discussion of actual safety results of the study drug, although this is the primary goal of the study.  Was this safe?  Were there any adverse events? The discussion about “resistant virus” found in some patients is not well described. Was this a resistance identified at the beginning of the trial or related to use of 10-1074?

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

We get no sense of whether the study drug was safe and whether it had antiviral activity in humans.

This is a small and very limited study looking at safety and antiviral activity of broadly neutralizing antibodies in a short-term sense (very different end-point than prior studies of antiviral therapy). While these results may support a larger study, the current data cannot be extrapolated to clinical outcomes.

We applaud the release for including at least one cautionary comment, that of the study’s first author Marina Caskey:

“Based on our findings we think these types of antibodies could be a viable substitute for the drugs currently being used in PrEP.  But to clearly demonstrate that these antibodies have an advantage over the pill that’s currently used, we would need to test them in large numbers of people and show that they remain active for a prolonged period of time in the body.”

The suggestion that the antibodies under study could replace current therapies goes well beyond the study results. Several steps are going to be needed between this preliminary safety study and using broadly neutralizing antibodies clinically as treatment and/or prevention.

Does the news release commit disease-mongering?

Satisfactory

There was no overt disease mongering but the release states that “people who do not have HIV are at substantial risk of getting it,” especially those with multiple sexual partners or an HIV-infected partner.

The release didn’t provide context on HIV prevalence. However, it did offer context on current antiretroviral therapy and its drawbacks.

“Today, HIV is typically treated with antiretroviral therapy, a drug regimen that became available in the 1990s. Although it has been a lifesaver for people infected with the virus, antiretroviral medications have significant drawbacks: they can cause severe side effects, and patients have to take them for life. This is why researchers continue to look for other ways to control the virus—and broadly neutralizing antibodies could prove to be part of an alternate treatment strategy.”

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The major funding sources for the study are listed at the end of the release. The online version of the published study notes that Tibor Keler, one of the study authors, is employed by Celldex Therapeutics which manufactures 10-1074. This should have been noted in the release.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release mentions that broadly neutralizing antibodies may eventually be an alternative to currently available antiviral therapy as well as pre-exposure prophylaxis, PrEP, (a lower dose of antiviral therapy taken as prevention). The current study doesn’t look at clinical outcomes so the comparison may be premature, although it’s presented in a pretty general way.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

We can assume that this is preliminary data collection but it would have been useful if the release included information about how long the research process may be before eligible patients might have access to this new therapy. Next steps regarding future clinical trials are mentioned in the last paragraph.

Does the news release establish the true novelty of the approach?

Satisfactory

The release states this was the first human trial involving a new drug agent and that is indeed novel. The drug must still undergo considerable research on larger groups of patients before its value is proven.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t include overtly sensational language. But some of the claims, such as “the most potent of its kind so far” and “showing early promise,” may not be wholly justified by the research so far. The author quotes contain some statements that go beyond the results as well.

Total Score: 5 of 10 Satisfactory

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