This article discusses a once-a-day HIV treatment that may be available at some unknown time in the future. The treatment has been submitted to the FDA for approval. While the companies may be genuinely pleased with the studies they have done to demonstrate that the drugs in combination work as well as they do separately, those results still need to be evaluated by the FDA. This is an article on a re-packaging of a combination of medications currently used for the treatment of AIDS. The story fails to discuss issues that such re-formulation may cause that could be of concern to consumers. In several ways the story reads like it came from a drug company news release, although there is no direct evidence of that. The story would have been helped by interviews with independent experts who could address the evidence. There was really no evidence discussed in this story at all.
There was no cost of treatment information; how would this once-a-day pill compare to the two pill once-a-day combination?
There was no quantification of benefits of treatment. While it is easy to forget to take medications that are taken several times during the day, it is also easy to forget to take a medication once-a-day. There were no data to indicate how compliance compared.
No harms of treatment or side effects were mentioned. Does the frequency of side effects differ when medication is taken once or more than once a day?
This article does not contain evidence. It appears to have been stimulated by “forward-looking” statements from one of the drug manufacturers involved in this partnership. It contains the view of one patient describing how difficult it is to remember to take daily prescription medications. This is a hurdle faced by many people with a variety of conditions other than HIV. The article did not contain evidence that compliance with taking medication once a day is actually better than dosing strategies that rely on medication taken multiple times a day.
In addition, the article failed to provide information about how effective the once-a-day regiment is as compared to other dosing schemes.
No evidence of disease mongering.
While there were several people interviewed for the story, an independent source with expertise on the subject should have been asked to comment on the therapeutic claims. One patient provides a single patient perspective; two individuals working for AIDS advocacy groups are also quoted. However no expert was quoted on any clinical evidence demonstrating effectiveness of the proposed treatment.
While not mentioning all the approaches to HIV treatment, the article does include mention of a combination of pills that could be taken once a day and gave an example of one patient who had to take only 3 pills twice a day.
The story reports that the FDA is expected to approve the drug this year. But the timing of FDA approval is highly uNPRedictable and in some recent cases the FDA has rejected the advice of expert panels. This medication has only just been submitted for FDA approval.
The pill described would represent the first combination therapy for the treatment of HIV that necessitates taking medication only once a day. It is, however, a re-packaging of two existing treatments. So, if the story is going to let someone call this “a breakthrough,” it should at least explore what is novel and what isn’t.
We can’t be sure if the story relied solely or largely on a news release.