HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
2022 Rome Action Plan on Paediatric HIV & TB
ViiV Healthcare
Gilead, ViiV Healthcare and MSD commit to implement the principles of the Call to Action (CTA)[1] launched on 1st December 2021 by stakeholders[2] involved in studying antiretroviral agents for treatment and prevention of HIV to support greater inclusion of pregnant women and breastfeeding and contribute to a more equitable investigation of new HIV agents.This includes:
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26. Committing to complete embryo-fetal development (EFD) studies for new antiretroviral (ARV) drugs by end of Phase 2 clinical trials.
27. Committing at aiming to complete pre- and post-natal development studies (PPND) for new ARV drugs by the time of early Phase 3 clinical trial enrolment.
28. Committing to generate pharmacokinetic (PK) and early safety data in pregnancy for new drugs by end of Phase 3 clinical trial completion, in the assumption that there are no contraindications to use in pregnancy from pre-clinical studies.
[1] Idem 7
[2] Idem 8
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ViiV Healthcare, building on ongoing work to support generation of data during implementation research of CAB LA, commits to:
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32. Support investigators to allow women who become pregnant while taking CAB LA to continue CAB LA in pregnancy, following a discussion with their healthcare provider on the benefits and risks, and guided by the approved label.
33. Collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) in women who receive CAB LA PrEP or CAB/RPV LA treatment during pregnancy.
34. Support, facilitate and generate data on pregnancy, birth, and infant safety outcomes for CAB-LA in pregnancy and during lactation via ongoing clinical, non-interventional and implementation science studies and if needed with rapid initiation of additional dedicated studies.
35. Collect PK and safety data in women who become pregnant and elect to stay in the Phase 3 clinical study.
ViiV Healthcare updates
26. Sept 2024: There is a framework is in place which will be implemented for all future ViiV Healthcare drug development programmes. This action is now fully completed.
26. Q3 update: The framework to accelerate data generation for ARV use in pregnancy has been adopted and integrated into the drug development programmes, commitments 26, 27 and 28 are now completed.
26.May 2024: Ongoing progress - commitment now completed - the framework now implemented has become an integral part of all ViiV Healthcare drug development programmes. ViiV's commitment to accelerate data generation for ARV use in pregnancy remains a top priority.
26.Jan. 2024: Ongoing progress as outlined in Sept. 2023 update.
26. June 2023: Ongoing Commitment: The framework to include women of childbearing potential for products in development is now well established. Phase II clinical trials for N6LS (the BnAB programme) are designed to enrol women of childbearing potential.
26. October 2023:
Ongoing commitment: Ongoing progress as outlined in June update: June 2023 - The framework to include women of childbearing potential for products in development is now well established. Phase II clinical trials for N6LS (the BnAB programme) are designed to enrol women of childbearing potential.
27. Sept 2024: There is a framework is in place which will be implemented for all future ViiV Healthcare drug development programmes. This action is now fully completed.
27. Q3 update
The framework to accelerate data generation for ARV use in pregnancy has been adopted and integrated into the drug development programmes, commitments 26, 27 and 28 are now completed.
27. May 2024 Ongoing progress - commitment now completed - the framework now implemented has become an integral part of all ViiV Healthcare drug development programmes. ViiV's commitment to accelerate data generation for ARV use in pregnancy remains a top priority.
27. Jan. 2024: Ongoing progress as outlined in Sept. 2023 update.
27. June 2023: Ongoing Commitment: The framework to include women of childbearing potential for products in development is now well established. Phase II clinical trials for N6LS (the BnAB programme) are designed to enrol women of childbearing potential.
27. October 2023: Ongoing commitment: On going progress as outlined in June update. June 2023 -The framework to include women of childbearing potential for products in development is now well established. Phase II clinical trials for N6LS (the BnAB programme) are designed to enrol women of childbearing potential.
28. Sept 2024: There is a framework is in place which will be implemented for all future ViiV Healthcare drug development programmes. This action is now fully completed.
28. Q3 update: The framework to accelerate data generation for ARV use in pregnancy has been adopted and integrated into the drug development programmes, commitments 26, 27 and 28 are now completed.
28. May 2024: Ongoing progress - commitment now completed - the framework now implemented has become an integral part of all ViiV Healthcare drug development programmes. ViiV's commitment to accelerate data generation for ARV use in pregnancy remains a top priority.
28. Jan. 2024: Ongoing progress as outlined in Sept. 2023 update
28. Sept. 2023: Ongoing progress as outlined in June update.
28. June 2023: Ongoing Commitment: ViiV Healthcare is including women of childbearing potential in clinical trials. Should they become pregnant they are able to remain in studies as well as continue to be provided with treatment and care. Phase 2b studies are scheduled to start in 2023. Women of childbearing potential will also remain in Phase 3 studies should they become pregnant, and they will continue to receive treatment and care.
28. October 2023: Ongoing progress as outlined in June update. June 2023 -ViiV Healthcare is including women of childbearing potential in clinical trials. Should they become pregnant they are able to remain in studies as well as continue to be provided with treatment and care. Phase 2b studies are scheduled to start in 2023. Women of childbearing potential will also remain in Phase 3 studies should they become pregnant, and they will continue to receive treatment and care.
32. June 2023:
COMPLETED: ViiV Healthcare has established a framework which supports investigators to allow women who become pregnant - while taking CAB LA to continue this treatment in pregnancy, following a discussion with their healthcare provider on the benefits and risks, as well as guided by the approved label.
33. Sept 2024: Ongoing progress as outlined in Jan. 2024 update.
33. May 2024: Ongoing progress as outlined in Jan. 2024 update.
33. Jan. 2024: ViiV Healthcare continues its programme of studies to collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) in women who receive CAB LA PrEP (prevention) or CAB/RPV LA treatment during pregnancy.
33. June 2023: Ongoing Commitment: ViiV Healthcare has established a framework to collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) in women who receive CAB LA PrEP (prevention) or CAB/RPV LA treatment during pregnancy. In addition, we have ongoing data collection with the Antiretroviral Pregnancy Registry (APR) and PENTA's (Paediatric European Network for Treatment of AIDS) cohort (EPPICC - European Pregnancy and Paediatric Infections Cohort Collaboration).
34. Sept. 2024: Ongoing progress as outlined in Jan. 2024 update.
34. May 2024: Ongoing progress as outlined in Sept. 2023 update.
34. Jan. 2024: Ongoing progress as outlined in Sept. 2023 update.
34. Sept. 2023: June update still stands. In addition, with respect to the assessment of the initial data from the Antiretroviral Pregnancy Registry (APR), this was presented 27th June 2023 at the Birth Defects Research and Prevention Meeting, Charleston, South Carolina, US - https://birthdefectsresearch.org/meetings/2023/
The registry continues to collect data.
34. June 2023: Ongoing Commitment: ViiV Healthcare continues to undertake the work to support, facilitate and generate data on pregnancy, birth, and infant safety outcomes for CAB LA treatment in pregnancy and during lactation via ongoing clinical, non-interventional and implementation science studies - and if needed initiate additional dedicated studies. An assessment of the initial data from the Antiretroviral Pregnancy Registry (APR) is due to be presented 27th June 2023 at the Birth Defects Research and Prevention Meeting, Charleston, South Carolina, US - https://birthdefectsresearch.org/meetings/2023/
35. June 2023: COMPLETED: The framework to collect PK and safety data in women who become pregnant and elect to stay in Phase 3 clinical studies has been established. This now forms part of ViiV Healthcare's standard practice and will be implemented for the N6LS programme (bnAb programme) and future programmes.
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All partners commit to:
163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment.
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164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care.
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165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.
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166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.
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ViiV Healthcare commits to:
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245. Collaborate with key PAWG members and research networks to support ViiV to undertake appropriate modelling to inform the use of CAB LA for perinatal and postnatal prophylaxis.
246. Advance research and collaborate with WHO and research networks on the investigation of CAB LA injectables in the context of PNP and treatment for children and adolescents.
247. Contribute to the implementation of a platform trial to assess innovative options to deliver postnatal prophylaxis.
248. Collaborate with GAP-f partners to design and set up a dedicated platform for neonatal PK studies.
249. Support long-term follow up in the ODYSSEY trial, including long-term safety profile data by Q1 2024.
250. Collaborate with GAP-f partners to develop an enhanced monitoring and safety data platform for new and existing paediatric ARV drugs.
251. Shipping (GSK/ViiV Healthcare) study drugs (DTG) for DOLPHIN Kids in Q1 2023[1].
252. Advance research and contribute to collaborations and coordination designed to ensure more efficient and timely investigation of bNABs in the context of PNP and paediatric treatment.
[1] DOLPHIN-Kids is primarily a drug interaction study between DTG and the TB drug rifapentine in children and adolescents living with HIVin South Africa. ViiV is supporting this study by drug donation of DTG clinical trials’ material.
ViiV Healthcare updates
245. Sept. 2024 Ongoing progress as outlined in Sept 2023 update.
245. May 2024 Ongoing progress as outlined in Sept 2023 update.
245. Jan. 2024 Ongoing progress as outlined in Sept 2023 update.
245. Sept. 2023 Enabling work is underway to support initial dosing of CAB LA in neonates.
245. June 2023: ONGOING COMMITMENT - ViiV Healthcare held an internal two-day workshop on CAB LA for post-natal prophylaxis in 245. February 2023 to further discuss plans in detail and understand how to address the key gaps to make progress. Additionally, ViiV's Paediatric team have held meetings with PAWG members and paediatric research network members including the specific clinical pharmacology sub-group of PAWG to discuss post- natal prophylaxis (PNP).
246. Sept 2024 The MOCHA study is near completion. The CRAYON study continues to enrol participants. An interim analysis will be undertaken to determine dosing for lower weight cohorts.
246. May 2024 The MOCHA (IMPAACT2017) study in adolescents continues to progress. The CRAYON (IMPAACT2036) study has opened and is enrolling participants.
246. Jan. 2024 The MOCHA (IMPAACT2017) study in adolescents continues to progress. The CRAYON (IMPAACT2036) study has opened for recruitment.
246. Sept. 2023 The MOCHA (IMPAACT2017) study in adolescents continues to progress. Preparation activities for the CRAYON (IMPAACT2036) study are being finalised and recruitment will commence imminently.
246. June 2023: ONGOING COMMITMENT - There are two studies for CAB LA and RPV LA for treatment in paediatrics: MOCHA (IMPAACT2017) a study in adolescents is ongoing; and CRAYON (IMPAACT2036) a study in children is due to commence shortly.
247. Sept. 2024 Ongoing progress as outlined in Jan. 2024 update.
247. May 2024 Ongoing progress as outlined in Jan. 2024 update.
247. Jan. 2024 Continue to support discussions with clinical trial networks and GAP-f convened group.
247. Sept. 2023 On-going discussions with clinical trial networks, WHO and GAP-f. Meeting series planned for Oct. and Nov. 2023.
247. June 2023: ONGOING COMMITMENT - ViiV Healthcare participated in a GAP-f private sector dialogue on 6th June which included discussion on platform trials. ViiV also participated in a dialogue with industry and regulators on new ARVs strategies for PNP on 11th May. This discussion which included regulators and other external stakeholders also explored the role of platform trials for post-natal prophylaxis.
248. Sept. 2024 Ongoing progress as outlined in Jan. 2024 update.
248. May 2024 Ongoing progress as outlined in Jan 2024 update.
248. Jan. 2024 Continue to support discussions with clinical trial networks and GAP-f convened group.
248. Sept. 2023 On-going discussions with clinical trial networks, WHO and GAP-f. Meeting series planned for Oct. and Nov. 2023.
248. June 2023: ONGOING COMMITMENT - ViiV Healthcare participated in a GAP-f private sector dialogue on 6th June which included discussion on platform trials. ViiV also participated in a dialogue with industry and regulators on new ARVs strategies for PNP on 11th May. This discussion - which included regulators and other external stakeholders - also explored the role of platform trials for post-natal prophylaxis.
249. Sept 2024 Presented at AIDS, Munich July 2024. Additional updates to follow in the next quarter.
249. May 2024 Presented at CROI in March 2024 with an additional presentation at AIDS Munich in July 2024.
249. Jan. 2024 Presentation for a late abstract related to ODYSSEY long-term follow-up trial data is anticipated at CROI 2024.
249. Sept. 2023 The first presentation of ODYSSEY long-term follow-up trial data is anticipated to take place at AIDS 2024 - the 25th International AIDS Conference. This will take place in Munich, Germany - July 2024. The last subject completed the ODYSSEY study on 28th July 2023.
249. June 2023: ONGOING COMMITMENT - This remains a work in progress and ViiV Healthcare continues to support long term follow-up in the ODYSSEY trial.
250. Sept 2024 Protocol to be finalised shortly.
250. May 2024 Contract executed and protocol to be approved imminently.
250. Jan. 2024 Contract executed and protocol development currently underway.
250. Sept. 2023 Contract negotiations underway and protocol anticipated to be in place by mid-year 2024.
250. June 2023: REVISE COMMITMENT SCOPE NOW FOCUSED ON UGANDA [not 20 countries. EC funding bid by PENTA?). IAS CIPHER not involved in Uganda study] - ViiV and PENTA are working with the Ugandan MoH to assess data collected through the PENTA platform by collaborating on a study to explore safety and effectiveness of DTG-based regimens among paediatric population in Uganda.
251. June 2023: COMPLETED - The first shipment of ViiV Healthcare DTG clinical trials’ material for this study was successfully delivered to the Sponsor on 5th January.
252. Sept. 2024 Ongoing progress as outlined in Jan 2024 update.
252. May 2024 Ongoing progress as outlined in Jan 2024 update.
252. Jan. 2024 ViiV Healthcare continues its support of IMPAACT 1115 (through provision of DTG); a study using bNABs in combinations with ARVs in infants. ViiV Healthcare continues to participate in multisector discussions as part of a taskforce on bNABs in paediatrics.
252. Sept. 2023 In July 2023, ViiV Healthcare participated in a bNABs task force meeting at the International AIDS conference in Brisbane. The IMPAACT1115 study is anticipated to start by the end of 2023.
252. June 2023: ONGOING COMMITMENT - ViiV Healthcare is providing support (through the provision of DTG as standard of care comparator) to the IMPAACT1115 study which is exploring bNABs in the context of PNP.
ViiV commits to:
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407. Support the study the possible interaction between Dolutegravir and Rifapentine.
407. June 2023: COMPLETED -This has been duplicated under a Sanofi commitment (commitment # 407) as well as featuring in a ViiV Healthcare commitment (commitment # 251) - The first shipment of VH DTG clinical trials’ material for this study was successfully delivered to the Sponsor on 5th January.