Tobias Polak

Results from expanded access programs: a review of academic literature 163 7♦ Comparison with other data When comparing the expanded access program with safety data from other clinical trials, the authors conclude that: ‘Safety data from this trial are aligned with prior Phase IIb/III clinical trials with no new or unexpected safety issues observed.’ Limitations include: ‘genotypic/phenotypic data for etravirine were not available at baseline at the time most subjects in this analysis were enrolled (i.e., sensitivity to etravirine was unknown), ARV selection was not randomized within subgroups, disease characteristics at baseline showed some variability across subgroups, the contribution of background ARVs to overall virologic and immunological improvements is unknown, laboratory assessments were non-centralized, and the safety data are limited as only SAEs and AEs leading to treatment discontinuation were recorded.’ Conclusion The authors conclude that: ‘This study suggests that clinicians were able to use etravirine with newly available agents, such as darunavir/ritonavir, and expanded access program drugs, such as raltegravir, to successfully construct suppressive regimens for treatment-experienced patients with HIV-1.’ As etravirine was utilized in combination with other new (darunavir/ritonavir) or experimental (raltegravir) antiretrovirals in a significant proportion of patients, this undoubtedly contributed to the response rates seen as well.

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