Recent Publications - No name

Global regulatory collaboration for the assessment of lenacapavir as a long-acting pre-exposure prophylaxis against HIV infection

Date:

3/5/26

Citation:

Kristyanto H, González-Tomé MI, Vlcek V, Josephson F, Vrijlandt P, Perombelon N. Global regulatory collaboration for the assessment of lenacapavir as a long-acting pre-exposure prophylaxis against HIV infection. Front Public Health. 2026 Feb 16;14:1760130. doi: 10.3389/fpubh.2026.1760130. PMID: 41778137; PMCID: PMC12950762.

The availability of long-acting pre-exposure prophylaxis (PrEP) to prevent HIV infection will be essential for disease control. Despite significant improvements in prevention strategies, the global HIV population was estimated to increase by 1.3 million in 2024, with Africa accounting for nearly half of all new carriers (1).

Long‐acting injectable cabotegravir and rilpivirine in observational cohort studies: A systematic review on virological failure, resistance and re‐suppression outcomes in virally suppressed individuals living with HIV

Date:

1/6/26

Citation:

Ring K, Elias A, Devonald M, Smuk M, Orkin C. Long-acting injectable cabotegravir and rilpivirine in observational cohort studies: A systematic review on virological failure, resistance and re-suppression outcomes in virally suppressed individuals living with HIV. HIV Med. 2025 Aug;26(8):1267-1288. doi: 10.1111/hiv.70057. Epub 2025 Jun 13. PMID: 40511953; PMCID: PMC12315068.

Introduction: Randomized controlled trial evidence suggests that long‐acting injectable (LA‐I) cabotegravir and rilpivirine (CAB+RPV) has similar virological failure (VF) rates to daily oral therapy, but clinical practice evidence is lacking. Integrase inhibitor (INI) resistance may limit future therapy. The optimal regimen is uncertain.

Health Topics:

LA/ER Injectable Therapy

A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV

Date:

7/21/25

Citation:

Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29. PMID: 40296638; PMCID: PMC12209996.

Long-acting (LA) cabotegravir 200-mg/mL (CAB200) injections are approved for HIV-1 prevention and as a complete LA HIV-1 treatment regimen with rilpivirine. A high-concentration suspension formulation, cabotegravir 400 mg/mL (CAB400-D), was developed to enable less frequent dosing and self-administration.

Health Topics:

HIV

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference

Date:

5/27/25

Citation:

Schug B, Beuerle G, Bilensoy E, Cook J, Fernandes E, Haertter S, Kuribayashi R, Mehta M, Paixao P, Seidlitz A, Tampal N, Tsang YC, Walstab J, Wedemeyer R, Welink J, Jiang W. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference. Eur J Pharm Sci. 2025 May 14:107129. doi: 10.1016/j.ejps.2025.107129. Epub ahead of print. PMID: 40379059.

At the 6th International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI), co-organised by the European Federation of Pharmaceutical Sciences (EUFEPS) and the Product Quality Research Institute (PQRI), critical bioequivalence (BE) topics were discussed by pharmaceutical scientists from academia, industry and regulatory agencies.

In Situ Forming, Enzyme-Responsive Peptoid-Peptide Hydrogels: An Advanced Long-Acting Injectable Drug Delivery System

Date:

8/7/24

Citation:

Coulter SM, Pentlavalli S, An Y, Vora LK, Cross ER, Moore JV, Sun H, Schweins R, McCarthy HO, Laverty G. In Situ Forming, Enzyme-Responsive Peptoid-Peptide Hydrogels: An Advanced Long-Acting Injectable Drug Delivery System. J Am Chem Soc. 2024 Aug 7;146(31):21401-21416. doi: 10.1021/jacs.4c03751. Epub 2024 Jun 26. PMID: 38922296; PMCID: PMC11311241.

Long-acting drug delivery systems are promising platforms to improve patient adherence to medication by delivering drugs over sustained periods and removing the need for patients to comply with oral regimens. This research paper provides a proof-of-concept for the development of a new optimized in situ forming injectable depot based on a tetrabenzylamine-tetraglycine-d-lysine-O-phospho-d-tyrosine peptoid-D-peptide formulation ((NPhe)4GGGGk(AZT)y(p)-OH).

Health Topics:

LA/ER Injectable Therapy

Safety and Effectiveness From the CARISEL Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings

Date:

5/6/24

Citation:

Jonsson-Oldenbüttel, Celia MDa,b; Ghosn, Jade MD, PhDc,d; van der Valk, Marc MD, PhDe; Florence, Eric MD, PhDf; Vera, Francisco MD, PhDg; De Wit, Stéphane MDh; Rami, Agathe MDi; Bonnet, Fabrice MD, PhDj; Hocqueloux, Laurent MDk; Hove, Kai MResl; Ait-Khaled, Mounir PhDl; DeMoor, Rebecca MScm; Bontempo, Gilda MDn; Latham, Christine L. MSn; Gutner, Cassidy A. PhDn; Iyer, Supriya MSco; Gill, Martin BScp; Czarnogorski, Maggie MD, MPHn; D’Amico, Ronald DO, MScn; van Wyk, Jean MBChBl. Safety and Effectiveness From the CARISEL Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings. JAIDS Journal of Acquired Immune Deficiency Syndromes ():10.1097/QAI.0000000000003448, May 06, 2024. | DOI: 10.1097/QAI.0000000000003448

Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. Here, we report Month 12 clinical outcomes in patient study participants (PSPs) in the CARISEL study.

A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs

Date:

5/3/24

Citation:

Khanolkar A, White S, Margerison E. A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs. Pharm Res. 2023 Oct;40(10):2303-2315. doi: 10.1007/s11095-023-03504-1. Epub 2023 Apr 3. PMID: 37012534.

Healthcare trends continue to move from hospital to home and many targeted therapies and precision medicines are now being designed to be self-administered by patients or delivered in a home setting. In the case of long acting injectables and bio-therapeutics, the importance of optimal drug/biologic-device combination in terms of user needs becomes critical for successful clinical outcomes.

A novel formulation enabled transformation of 3 HIV drugs Tenofovir-Lamivudine- Dolutegravir (TLD) from Short-Acting to Long-Acting All-in-One Injectable

Date:

9/28/23

Citation:

Perazzolo, Simone; Stephen, Zacharya; Eguchi, Masaa; Xu, Xiaolina; Fratte, Rachele Dellea; Collier, Ann C.b; Melvin, Ann J.c; Ho, Rodney J.Y.a,d. A novel formulation enabled transformation of 3 HIV drugs tenofovir-lamivudine-dolutegravir (TLD) from short-acting to long-acting all-in-one injectable. AIDS ():10.1097/QAD.0000000000003706, August 25, 2023. | DOI: 10.1097/QAD.0000000000003706

Objective: To develop an injectable dosage form of the daily oral HIV drugs, tenofovir (T), lamivudine (L), and dolutegravir (D), creating a single, complete, all-in-one TLD 3-drug-combination that demonstrates long-acting pharmacokinetics.

Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis

Date:

10/27/22

Citation:

Blair HA. Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis. Drugs. 2022 Oct 18. doi: 10.1007/s40265-022-01791-3. Epub ahead of print. PMID: 36255686.

Cabotegravir extended-release (ER) injectable suspension (Apretude™) is the first long-acting injectable option to be approved for HIV-1 pre-exposure prophylaxis (PrEP). As an HIV-1 integrase strand transfer inhibitor, cabotegravir ER injectable suspension prevents DNA integration and inhibits HIV-1 replication.

Health Topics:

HIV

Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling

Date:

10/27/22

Citation:

Kinvig H, Cottura N, Lloyd A, Frivold C, Mistilis J, Jarrahian C, Siccardi M. Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling. Eur J Drug Metab Pharmacokinet. 2022 Sep 30. doi: 10.1007/s13318-022-00793-6. Epub ahead of print. PMID: 36178586.

Technologies for long-acting administration of antiretrovirals (ARVs) for the prevention and treatment of HIV are at the forefront of research initiatives aiming to tackle issues surrounding drug adherence with the current standard of once-daily oral administration. Islatravir (ISL) is an emerging ARV that shows promising characteristics for long-acting prevention and treatment both orally as well as through alternative routes of administration.

Health Topics:

HIV

Recent Publications - No name

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