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

Access full article:

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.

Categories

CRS
Topics

Clinical Trials

A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

Read More

A5384: A Phase II, Randomized, Open-Label Trial of a...

Study Description A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease...

Read More

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

Read More

A5253: Sensitivity and Specificity of Mycobacterium...

An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with...

Read More

P1077FF: Formula Feeding Version of the PROMISE Study...

1077FF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More