A quieter HIV warning
India has made major progress against HIV over the past two decades, but the latest numbers are showing that the problem has not disappeared completely. New HIV infections increased for three consecutive years after 2020, reaching 68,451 cases in 2023 before falling to 64,470 in 2024. That remains far below the estimated 2010 level, yet the recent pattern has raised concerns about whether progress is becoming harder to maintain.
The issue is not simply about the number of infections being recorded each year. HIV prevention also depends heavily on whether people at risk can consistently use the available preventive medicines. Daily tablets can work extremely well, but remembering them every day is not always easy for everyone. Stigma, privacy concerns, travel, irregular routines and limited healthcare access can all affect adherence.
That is where twice-yearly lenacapavir is attracting attention. The medicine offers a very different approach to HIV prevention because protection can be maintained with injections given only twice a year. The World Health Organization has recommended injectable lenacapavir as an additional HIV pre-exposure prophylaxis option.
Why recent numbers matter
India’s HIV story is not one of uncontrolled growth. The country has actually achieved a substantial reduction in new infections compared with earlier years, supported by prevention programmes, testing, awareness campaigns and wider access to antiretroviral treatment.
Still, the movement in recent years deserves attention because new infections rose from 57,549 in 2020 to 62,970 in 2021, then 66,410 in 2022 and 68,451 in 2023. The figure later declined to 64,470 in 2024, but it remains important to understand why the downward trend has not continued consistently.
India also has a large population living with HIV, estimated at around 2.56 million people. Even though overall adult HIV prevalence remains relatively low at around 0.20 percent, the size of the population means prevention continues to have major public health importance.
Some groups and regions experience considerably greater vulnerability than the national average. Young people, transgender communities, men who have sex with men and people who inject drugs can face additional barriers around prevention, testing and healthcare access.
What makes lenacapavir different
Lenacapavir is an HIV-1 capsid inhibitor developed by Gilead Sciences, and its mechanism is different from many older HIV medicines. It interferes with the virus’s capsid, a structure involved in several stages of the HIV replication process.
For prevention, however, the biggest attraction may be much simpler than its molecular mechanism. It does not require someone to remember a preventive tablet every single day.
The prevention regimen involves an initial oral dosing schedule followed by subcutaneous injections every six months. Before starting PrEP, a person must be confirmed to be HIV-negative, while ongoing HIV testing remains important during prevention. This is because using PrEP when someone already has an undiagnosed HIV infection can create concerns around drug resistance.
That six-month schedule could make a major practical difference for people who struggle with daily medication routines.
Trial results created attention
The enthusiasm around lenacapavir did not appear without evidence. Large Phase 3 clinical trials produced unusually strong results for HIV prevention.
In the PURPOSE 1 trial involving adolescent girls and young women in South Africa and Uganda, there were no HIV infections among 2,134 participants who received twice-yearly lenacapavir during the primary analysis period. The result translated into 100 percent efficacy in that trial comparison.
PURPOSE 2 looked at different populations, including cisgender men, transgender people and gender-diverse participants who have sex with male partners. Two HIV infections occurred among 2,179 participants receiving lenacapavir, and the trial found a 96 percent reduction in HIV incidence compared with background incidence. It was also more effective than daily oral TDF/FTC in the trial comparison.
The 100 percent figure from PURPOSE 1 needs some explanation, because it should not be interpreted as an absolute guarantee that infection is impossible. Clinical trial results describe what happened among participants during the studied period. They do not mean that every individual receiving the medicine will have identical protection under every circumstance.
Daily pills have a real barrier
HIV prevention medicines can only provide their full benefit when people can use them properly and consistently. That sounds straightforward, but real life is usually more complicated.
Someone may forget a tablet occasionally. Another person may avoid carrying PrEP because they do not want friends or family asking questions. Some people may experience pill fatigue after taking medication repeatedly for long periods. Others may have difficulty reaching clinics regularly or maintaining a stable routine.
These issues are especially important because many people taking PrEP do not feel sick. They are taking medicine to prevent an infection that they may never acquire.
Lenacapavir changes that routine considerably. Instead of having prevention depend on remembering a pill every day, the medication is administered only twice annually. WHO has specifically highlighted the potential value of long-acting prevention for people facing challenges with daily adherence, stigma or healthcare access.
India now has an access opportunity
The discussion becomes even more relevant for India because Indian pharmaceutical companies are moving toward domestic production of generic lenacapavir.
According to recent reporting, an expert panel under India’s Central Drugs Standard Control Organisation recommended waiving local Phase 3 clinical trials and bioequivalence requirements for generic lenacapavir for PrEP applications from Dr Reddy’s Laboratories and Emcure Pharmaceuticals. The companies would still face post-marketing study requirements for the prevention indication.
That development could potentially shorten the regulatory pathway for bringing generic versions to the Indian market.
Affordability will be a crucial part of the story. A highly effective medicine has limited public health impact if people who need it cannot realistically obtain it. India already has a major role in producing affordable generic HIV medicines for global markets, so domestic manufacturing could eventually support wider access if pricing and distribution are handled effectively.
The exact availability, pricing and implementation pathway will still matter greatly.
Prevention needs more than medicine
Lenacapavir should not be viewed as a replacement for every existing HIV prevention method. HIV prevention works best when people have multiple options and can choose an approach that fits their circumstances.
Condom use, HIV testing, treatment for people living with HIV, harm-reduction services, sexual-health education and existing PrEP options remain important parts of the broader response.
There is also an important public-health principle involved here. People should be able to access HIV prevention without facing unnecessary stigma or judgement.
Testing is equally important because prevention and diagnosis are connected. Someone who has already acquired HIV needs appropriate treatment rather than prevention medication alone. Effective antiretroviral treatment can suppress HIV to undetectable levels, allowing people to live much healthier lives and preventing sexual transmission when viral suppression is maintained.
So the goal is not simply adding another drug. It is building a prevention system that people can actually use.
The affordability question remains
The biggest question for India may eventually be less about whether lenacapavir works and more about how widely people can access it.
Generic manufacturing could potentially make the medicine considerably more affordable than an expensive branded product. But manufacturing approval, regulatory requirements, pricing agreements, healthcare delivery and public-sector procurement will all influence what happens next.
There is also the practical question of where injections will be provided and how regularly people will return for them. A six-monthly medicine reduces the burden of daily tablets, but patients still need scheduled healthcare contact for injections and HIV testing.
If those systems are designed properly, the twice-yearly schedule could become one of the medicine’s biggest strengths.
Why six months could matter
The importance of lenacapavir is ultimately about making HIV prevention easier to maintain.
India has already shown that sustained prevention and treatment programmes can reduce the country’s HIV burden substantially. The recent fluctuations in new infections are a reminder that progress cannot simply be assumed to continue automatically.
A prevention option that requires only two doses each year could help address some of the everyday barriers associated with daily PrEP. Clinical evidence has shown very high protection, while WHO has formally recommended twice-yearly injectable lenacapavir as an additional PrEP option.
For India, the next stage will involve access, affordability, awareness and responsible implementation. The medicine itself is only one part of that equation.
Conclusion: A new prevention window
India’s HIV response has made considerable progress, but recent infection figures show why prevention still needs attention. Twice-yearly lenacapavir could offer an important new option for people who find daily PrEP difficult because of routine, stigma, privacy or adherence challenges. Its strong clinical results and WHO recommendation make it one of the most significant recent developments in HIV prevention.
The real impact in India will depend on whether the medicine becomes affordable, accessible and properly integrated into existing HIV services. If those pieces come together, six-monthly prevention could help close an important gap between having an effective HIV medicine and making that medicine practical for everyday life. Readers should follow updates from India’s health authorities and trusted HIV-care providers for availability and eligibility information.
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