IMPAACT Shares Study Results at CROI 2022 Poster Presentations
The IMPAACT Network is proud to present research in 14 abstracts as poster presentations at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022. Click here to view all 17 presentations, including oral presentations, when available.
Below are highlights from key abstracts sharing findings in posters presented at CROI.
Safety and PK of Long-acting Cabotegravir and Rilpivirine in Adolescents
Study: IMPAACT 2017
IMPAACT 2017, also known as MOCHA (More Options for Children and Adolescents), is a Phase I/II, open‐label, non‐comparative study of oral cabotegravir (CAB), long-acting injectable CAB (CAB-LA), and long-acting injectable rilpivirine (RPV-LA) in virologically-suppressed children and adolescents living with HIV-1 who are 12 to less than 18 years. The study aims to provide data to extend the use of this long-acting antiretroviral regimen to adolescents living with HIV. IMPAACT 2017 is taking place in Botswana, South Africa, Thailand, Uganda, and the United States.
Parents/caregivers of adolescent participants in the United States may also be enrolled to take part in a single in-depth qualitative interview to contribute to the evaluation of tolerability and acceptability of the study drugs.
Study Results
Findings presented at CROI 2022 are based on interim data collected through Week 16, from 23 participants enrolled in the U.S. to Cohort 1 who received either oral CAB or oral RPV followed by three injections of either CAB-LA or RPV-LA; and ten parents/caregivers who completed an in-depth interview. Results are described below.
- CAB-LA and RPV-LA, when given individually and with a background ART regimen, are well-tolerated and achieve targeted pharmacokinetic concentrations in these adolescents.
- No new or unanticipated safety concerns were identified. Of the injection site reactions which occurred, all were Grade 1 or 2, and none led to treatment discontinuation.
- Adolescents and their parents/caregivers found the long-acting injection formulation and the single injectable study drug to be acceptable.
The study will continue to evaluate the safety, tolerability, acceptability, and pharmacokinetics of oral CAB, CAB-LA, and RPV-LA. These interim results and future results from the MOCHA study are expected to support expanded options of treatment formulations for children and adolescents living with HIV-1 to improve adherence and treatment satisfaction.
Read the long-form summary of IMPAACT 2017 and CROI results here.
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IMPAACT 2017 is also presenting research in another poster, Adolescent and Parent Experiences with Long-acting Injectables in the MOCHA Study. See it here.
IMPAACT 2019: PK & Safety of Dispersible ABC/DTG/3TC in Children with HIV 6 to <14 kg
Study: IMPAACT 2019
IMPAACT 2019 is a Phase I/II, open-label, multicenter, multiple dose study of abacavir/dolutegravir/ lamivudine (ABC/DTG/3TC) fixed dose combination tablets in treatment-experienced and treatment-naïve children living with HIV who are less than 12 years old. The study is taking place in Botswana, South Africa, Thailand, and the United States. Preliminary results were presented at IAS 2021.
Findings presented at CROI 2022 are based on data collected through the first four weeks on-study among 14 children enrolled in two weight bands (6 to less than 10 kg; 10 to less than 14 kg) taking ABC/DTG/3TC dispersible tablets.
Study Results
The dose of ABC/DTG/3TC provided in each weight band was confirmed. Findings through the first four weeks on-study showed that:
- Children 6 to less than 14 kg are able to take ABC/DTG/3TC dispersible tablets.
- ABC/DTG/3TC dispersible tablets are safe and well-tolerated in these children.
- ABC/DTG/3TC dispersible tablets achieve targeted pharmacokinetic exposures in these children.
A total of 57 children were enrolled in IMPAACT 2019; follow-up through 48 weeks of treatment is expected to be completed in mid-2022. Findings from this study are expected to support global efforts to expand the availability of DTG-containing treatment in pediatric-friendly formulations.
IMPAACT 2032: Remdesivir PK & Safety in Pregnant and Non-pregnant Women with COVID-19
Study: IMPAACT 2032
IMPAACT 2032 is a Phase IV, prospective, open-label, non-randomized study of remdesivir (RDV) pharmacokinetics (PK) and safety in pregnant and non-pregnant women receiving RDV for COVID-19 treatment as part of clinical care. It is the first study of the pharmacology of any COVID-19 treatment in pregnancy.
Pregnant people with COVID-19 are at higher risk of severe disease and adverse pregnancy outcomes. RDV was the first antiviral medication U.S. FDA-approved for COVID-19 treatment, and there are currently no PK data available for RDV in pregnant women with COVID-19. PK data in non-pregnant women with COVID-19 and pregnancy safety data are limited.
Study Results
Fifty-four women were enrolled in the study (26 pregnant, 28 non-pregnant). Findings presented at CROI are based on a preliminary data analysis that included 49 women with safety data and 30 women with PK data. In this initial analysis, data showed:
- Plasma and intracellular concentrations of remdesivir and its major metabolites were comparable between the pregnant and non-pregnant participants.
- Remdesivir was generally safe and well-tolerated. There were three adverse events deemed related to remdesivir: two bradycardia events that resulted in treatment discontinuation in two non-pregnant woman, and one grade 3 eGFR decrease in a non-pregnant woman that resolved without intervention. Six women experienced one or more SAEs, all of which were deemed unrelated to remdesivir.
- Of 11 women with pregnancy outcome data, three pregnancies resulted in pre-term birth, one was small for gestational age, and there was one pregnancy loss. This pregnancy loss (intrauterine fetal demise at 26 weeks) was deemed unrelated to RDV.
PK and safety investigations are ongoing. Follow-up is expected to be complete in April 2022.