Response to: weight gain stopping/switch rules for antiretroviral clinical trials

Response to comments by Taramasso and colleagues on weight gain stopping/switch rules for antiretroviral clinical trials

“…We welcome the contribution by Taramasso et al [1] to stopping rules for weight gain in clinical trials. Our original recommendation, to offer a voluntary switch to efavirenz in those on dolutegravir with the highest BMI gains, was made in the light of available evidence, and specifically in relation to continuation of patients enrolled into ADVANCE [2].…”

“…Therefore, our original recommendation could be strengthened, such that patients who gain weight on dolutegravir should be discouraged from switching to efavirenz. Nevertheless, the issue is probably irrelevant, as it seems unlikely that efavirenz will be a comparator drug in future studies, for all the reasons on the list of Taramasso et al [1]. Whether alternate regimens, such as those based on newer nonnucleoside reverse transcriptase inhibitors, such as doravarine, have a role to play here remains uncertain, and currently not relevant to most low-income and middle-income countries where such drugs remain inaccessible.…”