ViiV HEALTHCARE TO TRIPLE ANNUAL SUPPLY OF LONG-ACTING HIV PREP FOR LOW- AND MIDDLE-INCOME COUNTRIES
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- At least two million doses of long-acting cabotegravir for PrEP to be made available in 2025-2026 to meet growing demand where HIV burden and unmet need are greatest
- Strong progress made with generic manufacturers through Medicines Patent Pool (MPP) voluntary licensing agreement
- Despite availability of PrEP, an estimated 1.3 million people acquired HIV in 2023, highlighting urgent need to scale up access to innovative new options1
London, 7 October 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the company’s commitment to make at least two million doses of long-acting cabotegravir for HIV pre-exposure prophylaxis (CAB LA for PrEP) available for procurement for low- and middle-income countries (L&MICs) during 2025-2026. The new commitment will triple the company’s available supply versus 2024, to accelerate access and meet growing demand where the HIV burden and unmet need are greatest. The announcement was made at the HIV R4P 2024 conference, being held in Lima, Peru from 6 – 10 October.
Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare and President, Global Health at GSK, said: “Today’s announcement marks another important milestone in our efforts to accelerate access to the only long-acting PrEP available now -- CAB LA -- where it’s needed most. We know long-acting PrEP provides a crucial option to suit the needs and circumstances of populations disproportionately affected by HIV, including young women and girls in Sub-Saharan Africa. We are committed to working at pace with our partners and the community -- globally, regionally, and locally -- to continue enabling sustainable access to CAB LA for PrEP as a key part of our mission to help end the HIV epidemic.”
ViiV’s strategy for CAB LA for PrEP in L&MICs is to maximise rapid access and uptake for populations with highest unmet needs, in a sustainable way, centred on partnership and integration into existing healthcare services and HIV prevention programmes.
The roll-out of CAB LA for PrEP -- the first long-acting injectable PrEP option -- is progressing at record pace in Sub-Saharan Africa (SSA) and lower income countries. Following the first approval of CAB LA for PrEP by the U.S. FDA in December 2021, under the brand name Apretude, regulatory submissions have been prioritised in countries where the HIV burden is greatest; almost half of the approvals to date are in SSA and 79% are in low, lower-middle and upper-middle income countries.
ViiV-manufactured CAB LA for PrEP is available at a not-for-profit price for roll-out in low-income, least developed, and SSA countries, via partners including the United States President's Emergency Plan For AIDS Relief (PEPFAR), and The Global Fund. The first of these rollouts was in Zambia in February 2024, just two years after the U.S.; since then, initiations have started in Malawi, Zimbabwe, Eswatini and Ukraine. By the end of 2024, ViiV will have supplied CAB LA for PrEP to key partners for roll-out to a total of 14 countries (13 countries in SSA and Ukraine).
Expanding capacity and improving affordability in resource-limited settings is critical to ensuring sustainable access to innovative medicines. In addition to providing CAB LA for PrEP at a non-profit price, ViiV announced the signing of a licensing agreement with the Medicines Patent Pool in July 2022, to enable the development of generic formulations. ViiV is actively engaged with the generic manufacturers, providing technology transfer and expertise, to expedite this process and the availability of generic CAB LA for PrEP.
Apretude (CAB LA for PrEP) has received marketing authorisation from 24 regulatory agencies, covering 53 countries. For more information on approvals and submissions around the world, click here.
Indication and Important Safety Information for Apretude (cabotegravir 200 mg/mL extended-release injectable suspension)
Apretude is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. Apretude is administered as a single 600-mg (3-mL) intramuscular (IM) injection of cabotegravir in the muscle of the buttock by a health care professional once every 2 months.
WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
See full prescribing information for complete boxed warning.
Individuals must be tested for HIV-1 infection prior to initiating Apretude or oral cabotegravir, and with each subsequent injection of Apretude, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Apretude for HIV-1 PrEP by individuals with undiagnosed HIV-1 infection. Do not initiate Apretude for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving Apretude for PrEP must transition to a complete HIV-1 treatment regimen.
CONTRAINDICATIONS
- Unknown or positive HIV-1 status.
- Previous hypersensitivity reaction to cabotegravir.
- Coadministration with drugs where significant decrease in cabotegravir plasma concentrations may occur.
WARNINGS AND PRECAUTIONS
- Use Apretude for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of comprehensive management to reduce the risk of HIV-1 acquisition.
- Potential risk of developing resistance to Apretude if an individual acquires HIV-1 either before or while taking Apretude or following discontinuation of Apretude. Reassess risk of HIV-1 acquisition and test before each injection to confirm HIV-1 negative status.
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals up to 12 months or longer.
- Hypersensitivity reactions have been reported in association with other integrase inhibitors. Discontinue Apretude immediately if signs or symptoms of hypersensitivity reactions develop.
- Hepatotoxicity has been reported in patients receiving cabotegravir. Clinical and laboratory monitoring should be considered. Discontinue Apretude if hepatotoxicity is suspected.
- Depressive disorders have been reported with Apretude. Prompt evaluation is recommended for depressive symptoms.
ADVERSE REACTIONS
The most common adverse reactions (all grades) observed in at least 1% of subjects receiving Apretude were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
- Refer to the full prescribing information for important drug interactions with Apretude.
- Drugs that induce uridine diphosphate glucuronosyltransferase (UGT1A1) may significantly decrease plasma concentrations of cabotegravir.
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using Apretude to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation.
- Pediatrics: Not recommended in individuals weighing less than 35 kg.
Please see full Prescribing Information.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024.
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Reference:
- UNAIDS 2024 Global AIDS Update: The Urgency of Now. Available at https://www.unaids.org/sites/default/files/media_asset/2024-unaids-global-aids-update_en.pdf. Last accessed October 2024.
