MOPEB235
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Background: Short-term results of the OPTIONS trial showed that NRTIs can be safely omitted from therapy as long as the regimen has cumulative activity of >2 active ARVs. The long-term durability of this approach and outcomes in persons with more-extensive resistance are uncertain.
Methods: Treatment-experienced participants with virologic failure and cumulative activity >2 active ARVs received an optimized regimen and were randomized to Omit or Add NRTIs. A third Highly-Resistant group (cumulative activity ≤2 active agents) received optimized regimen including NRTIs.
Results: At week 96, among 360 participants randomized to Omit (n=179) or Add NRTIs (n=181), 70% and 65% had VL< 200 copies/mL, respectively. In the Highly-Resistant group (n=53), 53% had VL< 200 copies/mL. Virologic failure was uncommon after week 48 (Figure 1).Younger age (≤46 vs. >46, OR=4.4 [95%CI 2.4, 8.2], p< 0.01) and starting fewer ARVs (1-2 vs. 4-6, 6.9 [2.0, 24.0]; 3 vs 4-6, 3.0[1.4, 6.5], p< 0.01) were associated with higher odds of virologic failure. Among those with virologic failure (randomized groups), treatment-emergent phenotypic resistance occurred in 3.4% for darunavir and 16% for etravirine. Among those with virologic failure on raltegravir (overall population), major primary integrase resistance mutations emerged in 11%. Quality-of-life scores increased after regimen initiation.
(Figure 2)
Conclusions: NRTIs can be safely omitted from HIV salvage therapy 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.


Figure 1. Cumulative probability of virologic failure over time by treatment group.
[Figure 1. Cumulative probability of virologic failure over time by treatment group.]




Figure 2. Quality of life scores over time by treatment group.
[Figure 2. Quality of life scores over time by treatment group.]