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Antiretroviral Therapy in India (2025): Drugs, Indications, Contraindications, Mechanisms, and Prophylaxis (PEP/PrEP)
1Professor, Department of Emergency Medicine, Pacific Medical College and Hospital, Udaipur, Rajasthan, India, Corresponding Author.
Background:
India has made major gains in HIV control, with nationwide scale-up of antiretroviral therapy (ART), routine viral load monitoring, and simplified dolutegravir-based regimens. Yet gaps persist in differentiated service delivery, drug-resistance surveillance, and prevention implementation (PEP/PrEP).
Objectives:
To provide a comprehensive, India-focused review of currently available antiretroviral drugs and fixed-dose combinations (FDCs), indications and contraindications for ART initiation, core mechanisms of action by class, regimen selection and monitoring, and detailed, practical guidance on HIV postexposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), with attention to 2024-2025 updates.
Methods:
Narrative review of national guidance (NACO), WHO recommendations, and key implementation documents and peer-reviewed Indian literature (2018-2025), emphasizing policy-relevant updates and practical algorithms.
Key Findings:
(1) First-line ART in India is an FDC of tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD), with alternatives guided by renal, hepatic, pregnancy, TB cotreatment, and toxicity considerations. Viral load monitoring and "Treat All" remain policy cornerstones. (2) PEP: NACO's national PEP document continues to list a 28-day triple regimen with TDF + 3TC + EFV started as soon as possible (preferably ≤2 h; within 72 h). Several institutions have operationalized DTG-based PEP (TDF/3TC/DTG) in line with broader ART updates and WHO's 2024 PEP guidance favoring 3-drug regimens. (3) PrEP in India: DCGI approved TDF/FTC for PrEP; national technical guidance exists, but programmatic rollout remains uneven. Global prevention options expanded with FDA approval (June 2025) of twice-yearly injectable lenacapavir for PrEP. Indian availability will depend on future regulatory decisions and access arrangements.
Conclusion:
India's ART platform is strong and increasingly INSTI-based. Scaling PrEP, standardizing DTG-aligned PEP, fortifying viral load and resistance monitoring, and integrating long-acting prevention as it becomes available are the next priorities.
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