Browsing by Author "Ndung'u T"

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    Multi-stakeholder consensus on a target product profile for an HIV cure.
    (2021-Jan) Lewin SR; Attoye T; Bansbach C; Doehle B; Dubé K; Dybul M; SenGupta D; Jiang A; Johnston R; Lamplough R; McCune JM; Nabel GJ; Ndung'u T; Pottage J; Ripin D; Rooney JF; Sikazwe I; Nsubuga M; Warren M; Deeks SG
    Developing a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three distinct therapeutic modalities (combination therapies, ex-vivo gene therapy, and in-vivo gene therapy) for a target product profile for an HIV cure were identified. Using a process of expert face-to-face consultation and an online Delphi consultation, we found a high degree of agreement regarding the criteria for the optimum target product profile. Although the minimum attributes for a cure were debated, the broad consensus was that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. An intervention that successfully cured a reasonable fraction of adults would be sufficient to advance to the clinic. These target product profiles will require further discussion and ongoing revisions as the field matures.
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    The case for an HIV cure and how to get there.
    (2021-Jan) Dybul M; Attoye T; Baptiste S; Cherutich P; Dabis F; Deeks SG; Dieffenbach C; Doehle B; Goodenow MM; Jiang A; Kemps D; Lewin SR; Lumpkin MM; Mathae L; McCune JM; Ndung'u T; Nsubuga M; Peay HL; Pottage J; Warren M; Sikazwe I
    In light of the increasing global burden of new HIV infections, growing financial requirements, and shifting funding landscape, the global health community must accelerate the development and delivery of an HIV cure to complement existing prevention modalities. An effective curative intervention could prevent new infections, overcome the limitations of antiretroviral treatment, combat stigma and discrimination, and provide a sustainable financial solution for pandemic control. We propose steps to plan for an HIV cure now, including defining a target product profile and establishing the HIV Cure Africa Acceleration Partnership (HCAAP), a multidisciplinary public-private partnership that will catalyse and promote HIV cure research through diverse stakeholder engagement. HCAAP will convene stakeholders, including people living with HIV, at an early stage to accelerate the design, social acceptability, and rapid adoption of HIV-cure products.
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    The impact of the PEPFAR funding freeze on HIV deaths and infections: a mathematical modelling study of seven countries in sub-Saharan Africa.
    (2025-May) Hontelez JAC; Goymann H; Berhane Y; Bhattacharjee P; Bor J; Chabata ST; Cowan F; Kimani J; Knox J; Lora WS; Lungu C; Manne-Goehler J; Mauti J; Moshabela M; Mpembeni RM; Wa Mwanza M; Ndung'u T; Omondi E; Phiri S; Siedner M; Tanser FC; de Vlas SJ; Bärnighausen TW
    BACKGROUND: On January 24, 2025, the United States government issued an executive order to freeze all foreign aid programs, including The President's Emergency Plan for AIDS Relief (PEPFAR), for 90 days. A limited waiver option became available, but its implementation remains incomplete. We estimated the impact of these policy changes on HIV deaths and new infections in seven sub-Saharan African (SSA) countries-Ethiopia, Kenya, Malawi, South Africa, Tanzania, Zambia, and Zimbabwe -, which together account for about half of all people living with HIV in SSA. METHODS: We used STDSIM, an established individual-based simulation model, and previously published quantifications for the seven countries. We predicted changes in HIV deaths and new infections over the period 2025-2030 for four scenarios: (1) FINDINGS: A 90-day funding freeze would result in 60 thousand [95% UI: 49-71 thousand] excess HIV deaths for the INTERPRETATION: The sudden cessation of PEPFAR funding likely results in tens of thousands of HIV deaths and new infections. These losses of life and health should compel the United States government to rapidly and fully re-instate one of the most successful health programs in history. FUNDING: None.
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    The imperative for increased investment for an HIV cure.
    (2025-Jul-22) van Leeuwen R; Barré-Sinoussi F; Müller-Trutwin M; Sáez-Cirión A; Nijhuis M; Lewin SR; Ndung'u T; Riako-Anam F; Warren M; Sikazwe I; Poniatowski B; Grinsztejn B; Kityo C; Davis M; Søgaard OS; Altfeld M; Martinez-Picado J; Vandekerckhove L; Gramatica A; Sok D; Collins S; Yazdanpanah Y