Interim analysis of a phase-2a study has found that Islatravir shows promise of a once-monthly PrEP pill. Islatravir is the first nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently-under-research for HIV prevention and treatment. Presenting data of an ongoing study assessing the safety, tolerability and pharmacokinetics of oral islatravir in adults at low risk for HIV, Dr Sharon Hillier of Magee-Womens Research Institute & Foundation said that the drug-under-study was found to be safe and well tolerated. Preliminary pharmacokinetics analysis of biopsied tissues suggests rapid, sustained and adequate distribution of Islatravir with presence in the blood over time that researchers believe will correlate with protection. Two phase-3 efficacy studies of 60mg islatravir as a once-monthly oral PrEP regimen will begin this year. The study on women will begin in the USA in February 2021 and in 7 African nations in mid 2021. Another study, starting in late 2021, will be done among gay men and transgender women in Asia, South America and USA. Results are expected to be available by 2024, informed Dr Hillier.
Dr Hillier added that Islatravir could be a potential game changer. It is a very potent long-acting agent that can be used for HIV prevention or treatment. It is a little more forgiving in case people forget to take a dose on time - even if 2 weeks late they are still within the protective window. As it is to be taken only once a month it is easier to use, and easier to persist with, than the daily oral PrEP. The potential for 12 pills a year - one pill a month - if proved effective - can have a dramatic impact on HIV prevention.
In a HIVR4P session with journalists, Dr Raphael Landovitz, Professor of Medicine at the UCLA (University of California, Los Angeles) Center for Clinical AIDS Research & Education (CARE), informed that long acting injectable CAB has been paired with another injectable medication - long acting dapivirine, both injected once a month, for maintenance of HIV virological suppression in those who have undetectable viral load. It now has regulatory approvals in Canada and Europe. He said Cabotegravir is being developed both as part of HIV treatment regimen with dapivirine, and also separately by itself as an injectable PrEP agent.
no one size fits all
It is all about expanding the toolbox of prevention options, says Dr Ishwar Gilada, Governing Council Member of International AIDS Society (IAS) and President of AIDS Society of India. No one size fits all. India is home to 2.35 million people living with HIV (3rd largest number of people living with HIV after South Africa and Mozambique). Although PrEP is yet to be part of India's public health programme, Dr Gilada firmly believes that it is an important and integrated tool for larger prevention of HIV in India. In his opinion there should be no reservations for the use of this medicine-based prevention, if there is no reservation for the use of the barrier-based prevention condom. PrEP also works as a confidence builder when couples plan to have a baby.
But having new HIV prevention options alone will not help in ending the AIDS epidemic. Unless the people who need them are able to access and use these interventions, it will not be possible to bend the curve of new HIV infections. While scientists are burning the midnight oil to design new effective prevention products, public health policies and efforts seem to be failing down the line in delivering these gains to vulnerable populations.
Dr Daniel Were, a global public health specialist from Kenya lists four basic requirements for optimum rollout of new HIV prevention products:
- an enabling policy environment and centralised coordination
- community ownership
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