Long-term outcomes in a large randomized trial of HIV-1 salvage therapy: 96-week results of AIDS Clinical Trials Group A5241 (OPTIONS)

Citation: Gandhi RT, Tashima KT, Smeaton LM, Vu V, Ritz J, Andrade A, Eron JJ, Hogg E, Fichtenbaum CJ; ACTG A5241 Study Team. Long-term outcomes in a large randomized trial of HIV-1 salvage therapy: 96-week results of AIDS Clinical Trials Group A5241 (OPTIONS). J Infect Dis. 2019 May 28. pii: jiz281. doi: 10.1093/infdis/jiz281. [Epub ahead of print] PMID: 31135883

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https://www.ncbi.nlm.nih.gov/pubmed/31135883

BACKGROUND:
Short-term (48-week) results of the OPTIONS trial showed that nucleoside reverse transcriptase inhibitors (NRTIs) can be safely omitted from salvage therapy as long as the regimen has a cumulative activity of >2 active antiretroviral (ARV) medications. The long-term durability of this approach and outcomes in persons who have more-extensive HIV-1 drug resistance are uncertain.

METHODS:
Participants with virologic failure and anticipated ARV susceptibility received an optimized regimen and were randomized to Omit or Add NRTIs. A separate group with more resistance (cumulative activity ≤2 active agents) received an optimized regimen including NRTIs.

RESULTS:
At week 96, among 360 participants randomized to Omit or Add NRTIs, 70% and 65% had HIV-1 RNA <200 copies/mL, respectively. Virologic failure was uncommon after week 48. Younger age and starting fewer new antiretroviral medications were associated with higher odds of virologic failure. In the Highly Resistant group, 53% had HIV-1 RNA <200 copies/mL at week 96.

CONCLUSIONS:
HIV-1 salvage therapy can safely omit NRTIs without compromising efficacy or durability of response as long as the new regimen has a cumulative activity of >2 active drugs. Younger people and those receiving fewer new ARVs require careful monitoring. Even among individuals with more-extensive resistance, most achieve virologic suppression.

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