Regimen Selection in the OPTIONS Trial of HIV Salvage Therapy Regimen Selection in the OPTIONS Trial of HIV Salvage Therapy: Drug Resistance, Prior Therapy, and Race-ethnicity Determine the Degree of Regimen Complexity.

Topic:

HIV Prevention

Authors:

Tashima KT, Mollan KR, Na L, Gandhi RT, Klingman KL, Fichtenbaum CJ, Andrade A, Johnson VA, Eron JJ, Smeaton L, Haubrich RH. 

External Link:

Link to article

BACKGROUND: Regimen selection for highly treatment-experienced patients is complicated.

METHODS: Using a web-based utility, study team members reviewed antiretroviral (ARV) history and resistance data and recommended individual ARV regimens and nucleoside reverse transcriptase inhibitor (NRTI) options for treatment-experienced participants consisting of 3-4 of the following agents: raltegravir (RAL), darunavir (DRV)/ritonavir, tipranavir (TPV)/ritonavir, etravirine (ETR), maraviroc (MVC), and enfuvirtide (ENF). We evaluated team recommendations and site selection of regimen and NRTIs. Associations between baseline factors and the selection of a complex regimen (defined as including four ARV agents or ENF) were explored with logistic regression.

RESULTS: A total of 413 participants entered the study. Participants initiated the first or second recommended regimen 86% of the time and 21% of participants started a complex regimen. In a multivariable model, ARV resistance to NRTI (odds ratio [OR] = 2.2), non-nucleoside reverse transcriptase inhibitor (NNRTI, OR = 6.2) or boosted protease inhibitor (PI, OR = 6.6), prior use of integrase strand transfer inhibitor (INSTI, OR = 25), and race-ethnicity (all P ≤ 0.01) were associated with selection of a complex regimen. Black non-Hispanic (OR = 0.5) and Hispanic participants from the continental US (OR = 0.2) were less likely to start a complex regimen, compared to white non-Hispanics.

CONCLUSIONS: In this multi-center trial, we developed a web-based utility that facilitated treatment recommendations for highly treatment-experienced patients. Drug resistance, prior INSTI use, and race-ethnicity were key factors in decisions to select a more complex regimen.

HIV Clin Trials. 2015 Aug;16(4):147-56. doi: 10.1179/1945577115Y.0000000001. Epub 2015 Jul 27. PMID: 26212575

Categories

CRS
Topics

Clinical Trials

NWCS 408: Examining Longitudinal Cytokine Profiles in HIV-TB...

Using existing data from A5274 and data obtained from retrospectively testing available biospecimens, we propose the following...

Read More

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

Read More

A5288: MULTIOCTAVE, Management Using the Latest Technologies...

The study is being done to: test a strategy of using a resistance test to choose anti-HIV drugs. Resistance tests look at the...

Read More

P2001 (DAIDS ID 12026): Evaluating the Pharmacokinetics,...

TB is a major cause of illness and death in women of reproductive age. Pregnant and postpartum women with latent TB are at...

Read More

A5337: Safety and Efficacy of Sirolimus for HIV Reservoir...

When a person becomes infected with HIV the immune system (the system that helps fight infection) is weakened (partly because...

Read More