Asset Details
Do you wish to reserve the book?
2840. Long-term Efficacy, Safety, and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy: LATTE Week 312 Results
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
2840. Long-term Efficacy, Safety, and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy: LATTE Week 312 Results
Do you wish to request the book?
2840. Long-term Efficacy, Safety, and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy: LATTE Week 312 Results
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
2840. Long-term Efficacy, Safety, and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy: LATTE Week 312 Results
2019
Overview
Background Cabotegravir (CAB), an INI, is under development in both oral and long-acting (LA) injectable formulations. LATTE (NCT01641809) was designed to select a daily oral dose of CAB and evaluate a two-drug ART regimen with rilpivirine (RPV), as suppressive maintenance therapy. Results enabled the LATTE-2 (NCT02120352) study to evaluate CAB LA + RPV LA dosed once every 1 or 2 months. Methods Phase 2b, multicentre, partially blinded dose-ranging study in ART-naïve HIV infected adults, randomized 1:1:1:1 to the induction regimen of once-daily oral CAB 10, 30, or 60 mg or efavirenz (EFV) 600 mg with TDF/FTC or ABC/3TC through W24. CAB patients with VL <50 c/mL immediately prior to W24 discontinued NRTIs and began RPV 25 mg as a two-drug oral maintenance regimen through W96. No change was made to the EFV arm. After W96, at the start of the open-label (OL) phase, all patients randomized to CAB were given the option to continue and switch to the sponsor-selected dose of oral CAB 30 mg. EFV patients completed the study at W96. The OL phase was completed at W312 (288 weeks on CAB + RPV). Successful CAB + RPV patients transitioned to the POLAR study (NCT03639311). Results A total of 243 patients were randomized and initiated treatment (ITT-E). Of those randomized to CAB (n = 181), 160 patients began CAB + RPV (W24) and 138 continued into OL phase (W96). One hundred and ten patients successfully completed the study (W312). Among patients who began CAB + RPV at W24, 66% maintained <50 c/mL, 9% had HIV-1 RNA ≥ 50 c/mL, and 25% were categorized as “No Virologic Data” by Snapshot at W312 (ITT-ME). There were 11 protocol-defined virologic failures (PDVF) on CAB; only 2 occurring after W144. Six patients developed treatment emergent (TE) resistance to one or both agents during the study; of which 4 patients developed TE major INI resistance mutations, 3 after W96. The median increase in CD4+ cell count from Baseline was 393 cells/mm3 (−174 to 1118). During the maintenance and OL phases, 4% of CAB patients reported drug-related AEs ≥ Grade 2; SAEs occurred in 9% of CAB patients (none drug related); 3% of CAB patients withdrew due to AEs. 43% of CAB patients who entered maintenance phase reported TE lab abnormalities ≥ Grade 3. Conclusion As maintenance therapy in virologically suppressed patients, the 2DR CAB + RPV provided durable viral suppression through W312. Through 7 years of study, CAB + RPV continues to be generally safe and well tolerated. Disclosures All Authors: No reported Disclosures.
Publisher
Oxford University Press
Subject
