Dr. Sonali Kochhar, medical director India of OneWorld Health and one of the two Indian women chosen for the prestigious 2011 Yale World Fellows leadership initiative, provides a thoughtful discussion on PrEP within the Indian context.
MP: Could you please briefly introduce yourself, and tell us how you got involved in the field of HIV prevention?
SK: I was the Medical Director, India for the International AIDS Vaccine Initiative for seven years and was involved in the preparation and conduct of the first ever AIDS vaccine trials conducted in India.
I got involved in the field of HIV prevention because early on in my medical training, I saw firsthand how diseases like HIV not only severely impacted the person infected but also their whole families. The severe stigma and discrimination associated with the disease in developing countries like India only worsens the issues. Seeing women being disowned by their families and children thrown out of schools and shunned by society convinced me that it is imperative that safe, effective and accessible preventive options are found at the earliest to prevent these tragedies. History has shown that vaccines are often the most powerful and cost-effective disease prevention tools available. It is hoped that a preventive AIDS vaccine will stem the global HIV pandemic.
MP: What are your thoughts on PrEP, particularly within the Indian context?
SK: There is mounting evidence that pre-exposure prophylaxis might prove to be an important new prevention approach. The results of from the iPrEx trial were promising in showing that in MSM and transgendered women who have sex with men, daily TDF/FTC (tenofovir disoproxyl fumarate plus emtricitabine, Truvada) reduced the risk of HIV by 44 percent.
If proven safe and effective in all populations, PrEP could help address the urgent need for a female-controlled prevention method for women who are often unable, because of cultural and financial barriers, to negotiate condom use.
It could be used by men and women at risk due to sexual or drug-using behaviors, when combined with prevention measures like reducing the number of sexual partners, HIV counseling and testing, condom use, use of sterile syringes etc.
MP: What are the particular pros and cons, challenges, or issues of rolling out PrEP here? Do you think it should be made accessible to everyone?
SK: There are numerous questions about the implementation of PrEP outside of the research setting especially in the context of countries like India with problems like the lack of a strong evidence base on which to formulate decision making, an unregulated health sector and a highly vulnerable population often severely disadvantaged in terms of income, education, power structures and gender.
These include whether the intermittent use of the drugs will be effective, how the cost will be borne and how would the health and safety of PrEP users be monitored. The impact of PrEP may be strongly diminished or even reversed by behavioral disinhibition (increased risky sexual behavior because people may feel protected against HIV infection), especially in scenarios with low coverage and low effectiveness. PrEP would need to be used with other preventive modalities but it is not certain how this can best be done.
Large-scale PrEP use might encounter problems such as poor adherence and resistance. One of the problems of intermittent use, besides reduced effectivity, is possible emergence of resistant viruses.
If clinical trials demonstrate efficacy of PrEP, as many expect, the demand for its provision may increase rapidly. Indian Policymakers, Program Planners and Public Health Workers will need to prepare for this. This will include the development of national testing and assessment protocols, behavioral interventions, ensuring uninterrupted supply of PrEP and monitoring the population-level impacts of PrEP use.
To support the use of PrEP as a population-level prevention strategy, I feel that the following issues need to be resolved:
1) PrEP drugs – The challenges encountered in countries like India would include ensuring financing for an uninterrupted supply of drugs, training and retaining health workers; establishing and maintaining clinical, laboratory, and public health infrastructure; overcoming barriers to accessing care such as stigma, lack of awareness, and geographical distance; implementing appropriate monitoring and evaluation systems; sustaining patient adherence; and managing drug-related toxicity and resistant infections. Guidelines for PrEP eligibility, optimal PrEP dosing, necessary adherence, route of administration and channels for PrEP prescription and monitoring would need to be developed.
2) Safety screening – To address the risk of new HIV infection, including the acquisition of drug-resistant HIV and the development of secondary resistance in PrEP users, repeated and frequent HIV testing would be required. This will require laboratory costs and infrastructure expansion. PrEP may only be cost effective for individuals at high risk for HIV. Side effects of PrEP like loss of bone density or renal impairments, will require ongoing clinical and laboratory monitoring.
3) Integration of PrEP as part of comprehensive care – As PrEP implementation requires clinical assessment, prescription, routine testing, and long-term monitoring of PrEP users, it will require a frequent and stable interface between PrEP users and clinical providers in an ideal scenario.
MP: Looking at the big picture, who do you think would benefit most from PrEP?
SK: Keeping in mind the above mentioned challenges, initial efforts might target members of known high-risk groups, such as sex workers, high-risk men who have sex with men, HIV negative individuals in serodiscordant sexual partnerships, and high-risk injection drug users.
MP: Is there any experience that stands out to you from your time on the field, which had an impact on you or that you can’t forget?
SK: Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against. Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.
Dr. Sonali Kochhar is currently the medical director for India at OneWorld Health, where she leads efforts to develop safe, affordable, and accessible drugs and vaccines for diseases prevalent in the developing world.
 To know more about HIV/AIDS in LGBT communities, read HIV Prevention and LGBT Communities: Syndemics, Resilience, and Real Change.
[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]