The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans
Background: Evaluating long-term efficacy, safety and pharmacokinetics of long-acting cabotegravir + rilpivirine (CAB+RPV LA) in sub-Saharan African populations is important because of the region’s unique demographics and antiretroviral therapy resistance patterns. Objectives: To describe the 96-we...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
AOSIS
2025-07-01
|
| Series: | Southern African Journal of HIV Medicine |
| Subjects: | |
| Online Access: | https://sajhivmed.org.za/index.php/hivmed/article/view/1709 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849344143157886976 |
|---|---|
| author | Rosie Mngqibisa Yashna Singh Catherine Orrell Johan Lombaard Sandy Griffith Conn Harrington Ronald D’Amico William Spreen Marty St Clair Christine Latham Louise Garside Rodica Van Solingen-Ristea Veerle Van Eygen Fafa Addo Boateng Herta Crauwels Prosperity Eneh Ingrid Eshun-Wilsonova |
| author_facet | Rosie Mngqibisa Yashna Singh Catherine Orrell Johan Lombaard Sandy Griffith Conn Harrington Ronald D’Amico William Spreen Marty St Clair Christine Latham Louise Garside Rodica Van Solingen-Ristea Veerle Van Eygen Fafa Addo Boateng Herta Crauwels Prosperity Eneh Ingrid Eshun-Wilsonova |
| author_sort | Rosie Mngqibisa |
| collection | DOAJ |
| description | Background: Evaluating long-term efficacy, safety and pharmacokinetics of long-acting cabotegravir + rilpivirine (CAB+RPV LA) in sub-Saharan African populations is important because of the region’s unique demographics and antiretroviral therapy resistance patterns.
Objectives: To describe the 96-week efficacy, safety and pharmacokinetics of CAB+RPV LA in South African participants from the pooled FLAIR and ATLAS-2M Phase 3/3b randomised studies.
Method: Primary endpoint: proportion of participants with plasma HIV-1 RNA levels ≥ 50 copies/mL at Week 96. Secondary endpoints: proportion of participants with plasma HIV-1 RNA levels 50 copies/mL, confirmed virological failure (CVF; two consecutive plasma HIV-1 RNA ≥ 200 copies/mL), adverse events and pharmacokinetics.
Results: Sixty-six participants were included, (CAB+RPV LA, n = 49; current oral antiretroviral regimen [CAR], n = 17). Forty-five (92%) on CAB+RPV LA and 15 (88%) on CAR maintained HIV-1 RNA levels 50 copies/mL. At Week 96, two participants, one in each arm, had CVF. Ninety per cent on CAB+RPV LA and 76% on CAR of participants experienced an adverse event; six (12%) of which were drug-related (CAB+RPV LA: n = 6). Injection-site reactions were common (78% [Grade 1: 80%; Grade 2: 20%]). CAB and RPV trough plasma concentrations remained above respective in vitro protein-adjusted 90% inhibitory concentrations following all doses.
Conclusion: This subgroup analysis of South African participants demonstrated durable efficacy, acceptable safety profile and pharmacokinetics of injectable CAB+RPV LA up to 96 weeks, consistent with long-term data from other regions and studies. |
| format | Article |
| id | doaj-art-a82018ca1f3e4264a3edd9ec4722090b |
| institution | Kabale University |
| issn | 1608-9693 2078-6751 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | AOSIS |
| record_format | Article |
| series | Southern African Journal of HIV Medicine |
| spelling | doaj-art-a82018ca1f3e4264a3edd9ec4722090b2025-08-20T03:42:44ZengAOSISSouthern African Journal of HIV Medicine1608-96932078-67512025-07-01261e1e710.4102/sajhivmed.v26i1.1709912The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South AfricansRosie Mngqibisa0Yashna Singh1Catherine Orrell2Johan Lombaard3Sandy Griffith4Conn Harrington5Ronald D’Amico6William Spreen7Marty St Clair8Christine Latham9Louise Garside10Rodica Van Solingen-Ristea11Veerle Van Eygen12Fafa Addo Boateng13Herta Crauwels14Prosperity Eneh15Ingrid Eshun-Wilsonova16Ward D1, Enhancing Care Foundation, Wentworth Hospital, DurbanDesmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine, Department of Medicine, University of Cape Town, Cape TownDesmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine, Department of Medicine, University of Cape Town, Cape TownJosha Research, BloemfonteinViiV Healthcare, Durham, North CarolinaViiV Healthcare, Durham, North CarolinaViiV Healthcare, Durham, North CarolinaViiV Healthcare, Durham, North CarolinaViiV Healthcare, DurhamViiV Healthcare, Durham, North CarolinaPhastar, LondonThe Janssen Pharmaceutical Companies of Johnson and Johnson, BeerseThe Janssen Pharmaceutical Companies of Johnson and Johnson, BeerseJohnson & Johnson Middle East, FZ-LLC, AccraThe Janssen Pharmaceutical Companies of Johnson and Johnson, BeerseJanssen Scientific Affairs, LLC, Titusville, New JerseyThe Janssen Pharmaceutical Companies of Johnson & Johnson, Cape TownBackground: Evaluating long-term efficacy, safety and pharmacokinetics of long-acting cabotegravir + rilpivirine (CAB+RPV LA) in sub-Saharan African populations is important because of the region’s unique demographics and antiretroviral therapy resistance patterns. Objectives: To describe the 96-week efficacy, safety and pharmacokinetics of CAB+RPV LA in South African participants from the pooled FLAIR and ATLAS-2M Phase 3/3b randomised studies. Method: Primary endpoint: proportion of participants with plasma HIV-1 RNA levels ≥ 50 copies/mL at Week 96. Secondary endpoints: proportion of participants with plasma HIV-1 RNA levels 50 copies/mL, confirmed virological failure (CVF; two consecutive plasma HIV-1 RNA ≥ 200 copies/mL), adverse events and pharmacokinetics. Results: Sixty-six participants were included, (CAB+RPV LA, n = 49; current oral antiretroviral regimen [CAR], n = 17). Forty-five (92%) on CAB+RPV LA and 15 (88%) on CAR maintained HIV-1 RNA levels 50 copies/mL. At Week 96, two participants, one in each arm, had CVF. Ninety per cent on CAB+RPV LA and 76% on CAR of participants experienced an adverse event; six (12%) of which were drug-related (CAB+RPV LA: n = 6). Injection-site reactions were common (78% [Grade 1: 80%; Grade 2: 20%]). CAB and RPV trough plasma concentrations remained above respective in vitro protein-adjusted 90% inhibitory concentrations following all doses. Conclusion: This subgroup analysis of South African participants demonstrated durable efficacy, acceptable safety profile and pharmacokinetics of injectable CAB+RPV LA up to 96 weeks, consistent with long-term data from other regions and studies.https://sajhivmed.org.za/index.php/hivmed/article/view/1709clinical trialsphase 3viral suppressionresistancetreatmentafricaadherencearv |
| spellingShingle | Rosie Mngqibisa Yashna Singh Catherine Orrell Johan Lombaard Sandy Griffith Conn Harrington Ronald D’Amico William Spreen Marty St Clair Christine Latham Louise Garside Rodica Van Solingen-Ristea Veerle Van Eygen Fafa Addo Boateng Herta Crauwels Prosperity Eneh Ingrid Eshun-Wilsonova The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans Southern African Journal of HIV Medicine clinical trials phase 3 viral suppression resistance treatment africa adherence arv |
| title | The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans |
| title_full | The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans |
| title_fullStr | The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans |
| title_full_unstemmed | The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans |
| title_short | The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans |
| title_sort | 96 week outcomes and pharmacokinetics of long acting cabotegravir plus rilpivirine in south africans |
| topic | clinical trials phase 3 viral suppression resistance treatment africa adherence arv |
| url | https://sajhivmed.org.za/index.php/hivmed/article/view/1709 |
| work_keys_str_mv | AT rosiemngqibisa the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT yashnasingh the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT catherineorrell the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT johanlombaard the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT sandygriffith the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT connharrington the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT ronalddamico the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT williamspreen the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT martystclair the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT christinelatham the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT louisegarside the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT rodicavansolingenristea the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT veerlevaneygen the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT fafaaddoboateng the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT hertacrauwels the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT prosperityeneh the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT ingrideshunwilsonova the96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT rosiemngqibisa 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT yashnasingh 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT catherineorrell 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT johanlombaard 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT sandygriffith 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT connharrington 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT ronalddamico 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT williamspreen 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT martystclair 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT christinelatham 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT louisegarside 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT rodicavansolingenristea 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT veerlevaneygen 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT fafaaddoboateng 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT hertacrauwels 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT prosperityeneh 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans AT ingrideshunwilsonova 96weekoutcomesandpharmacokineticsoflongactingcabotegravirplusrilpivirineinsouthafricans |