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Patients May Not Benefit From Trials Involving Switching HIV Drugs

An increasingly used type of HIV study which involves switching patients on one type of antiretroviral therapy (ART) to another, to see whether the new drug is as good at preventing replication of the HIV virus, may be unethical, according to a new essay published in this week’s PLoS Medicine. The studies, termed non-inferiority trials, are only ethical if participants can meaningfully benefit from the treatment change and are more likely to benefit than suffer harm, according to Andrew Carr from the HIV unit in St Vincent’s Hospital in , , Jennifer Hoy from the infectious diseases unit in Alfred Hospital in , , and Anton Pozniak from the Chelsea and Westminster Hospital in London, UK. The authors argue in their essay that such trials are not in the best interests of patients, especially as often, these trials have inadequate numbers to assess the key expected benefit and report all outcomes.

The authors say: “There are several potential for patients of switching or simplifying ART. Potential advantages include reduced toxicity, pill burden, or cost. One key potential disadvantage is that effective, well-tolerated ART is abandoned.”

The authors argue that such trials often enrol patients who cannot benefit from the switch, do not capture or report all potential risks, and are designed with a view to a pharmaceutical company’s profits rather than participant benefit. They make a strong case for measuring, analysing and reporting relevant disadvantages of the switch and argue that patients must be informed about all potential advantages and disadvantages.

The authors conclude: “Switching ART regimens when virologically suppressed may be appropriate for many reasons, but the full risk-benefit profile should be determined beforehand. The diminishing antiretroviral drug pipeline suggests greater care will need to be given in coming years to extending the benefits of existing drugs for what is likely to remain lifelong therapy.”

Source

Funding: AC is supported by a Practitioner Fellowship of the Australian National Health and Medical Research Council, which had no role in manuscript conception, decision to publish, or preparation of the manuscript. No specific funding was received to write this article.
Competing Interests: AC is a member for the PLoS Medicine Editorial Board. AC has received research funding from Baxter, GlaxoSmithKline/ViiV Healthcare, , and Pfizer; consultancy fees from Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, and Merck; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. AC is funded in part by a Practitioner Fellowship of the Australian National Health and Medical Research Council. AC (but not JH or AP) was an investigator in the SWITCHMRK trial; no author participated in the MONET trial. AC has recently received research funding for a clinical trial sponsored by . JH’s institution has received research funding from GlaxoSmithKline/ViiV Healthcare, , and Merck; travel sponsorship from , Janssen-Cilag, and Merck; and JH has served on advisory boards for Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, Janssen-Cilag, Merck, and Roche. AP has received consultancy fees from Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, Merck, and Roche; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, Merck, and Roche and has received research funding from Bristol-Myers Squibb, , GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. No pharmaceutical company was involved in the writing this paper or decision to publish.
Citation: Carr A, Hoy J, Pozniak A (2012) The Ethics of Switch/Simplify in Antiretroviral Trials: Non-Inferior or Just Inferior? PLoS Med 9(7): e1001240. doi:10.1371/journal.pmed.1001240
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