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Drug resistance is a big problem for many people with HIVHIV.. Fortunately at least two new drugs in the pipeline have been developed specifically for patients whose treatment is failing. Darunavir (a protease inhibitor) and etravirine (a non-nucleoside reverse transcriptase inhibitor) both performed well in recent randomised trials, controlling viral replication significantly better than comparator drug regimens with no extra side effects. Participants in the etravirine trials had drug resistant disease.
The authors of a linked comment (p 3) say these new trials show that innovation is still alive and kicking in HIV research, and that one day there will be effective drugs of one sort or another for everyone. They are less upbeat, however, about the presentation of key data on etravirine, which were published in two separate papers. By failing to combine the data in one analysis, the researchers missed a golden opportunity to look at the outcomes that matter most to patients—opportunistic infections and death, they write. Divided data mean lower statistical power and an over reliance on surrogate measures of success, such as laboratory results. After pooling the data themselves, the comment's authors calculate that etravirine really can slow the progression of HIV disease. But the studies in isolation were too weak to report a significant result.
This kind of split publication does nothing for patients, but plenty for researchers (who get two chances to be first author), drug companies (who get two papers to submit to the regulatory authorities), and medical journals (who get twice the number of citations and twice the income from reprints), they write. Influential journals should insist on combining studies with such similar protocols.