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 Table of Contents  
EDITORIAL
Year : 2019  |  Volume : 21  |  Issue : 1  |  Page : 1-3

Can pre-exposure prophylaxis be a game changer to prevent new HIV infections? A discussion with an armed forces perspective


1 Department of Community Medicine, INHS Asvini and SSO (Health), HQWNC, Mumbai, Maharashtra, India
2 Department of Psychiatry and Director, Institute of Naval Medicine, INHS Asvini, Mumbai, Maharashtra, India
3 Department of Community Medicine, INHS Asvini, Mumbai, Maharashtra, India
4 Department of Neurology, INHS Asvini, Mumbai, Maharashtra, India

Date of Submission18-May-2019
Date of Acceptance29-May-2019
Date of Web Publication19-Jun-2019

Correspondence Address:
Surg Capt (Dr) Sougat Ray
Department of Community Medicine, INHS Asvini, and SSO (Health), HQWNC, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmms.jmms_33_19

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How to cite this article:
Ray S, Goyal S, Tawar S, Bhaskar V, Wilson V. Can pre-exposure prophylaxis be a game changer to prevent new HIV infections? A discussion with an armed forces perspective. J Mar Med Soc 2019;21:1-3

How to cite this URL:
Ray S, Goyal S, Tawar S, Bhaskar V, Wilson V. Can pre-exposure prophylaxis be a game changer to prevent new HIV infections? A discussion with an armed forces perspective. J Mar Med Soc [serial online] 2019 [cited 2019 Nov 21];21:1-3. Available from: http://www.marinemedicalsociety.in/text.asp?2019/21/1/1/260661




  Introduction Top


With tremendous advances in prevention and control of the HIV/AIDS epidemic, two critical components have evolved, one is the early use of antiretroviral therapy (ART) and the other is administration of pre-exposure prophylaxis (PrEP). ART suppresses the viral load in an HIV-positive individual to an extent that the transmission of the virus is reduced to zero. This concept also campaigns as undetectable equals untransmittable (U = U).[1] PrEP on the other hand can reduce the risk of getting HIV from sex by >90% and can even be lower if combined with condoms and other prevention methods.[2],[3],[4] Recent scientific evidence of PrEP as an HIV prevention tool is strong and merits attention from policymakers and stakeholders from all sections of the society.

Although HIV/AIDS is presently regarded as a chronic manageable disease, the incidence of HIV continues to occur although at a much lesser rate. In 2017, an estimated 1.8 million individuals worldwide were diagnosed as HIV positive, resulting in around 5000 new infections per day.[5] In India, the incidence of HIV is estimated to be 88,000[6] and has shown a sharp downward trend in the present decade. The incidence of new HIV infections in the Indian military population has shown the same drift as in the country, slowing down considerably but occurring persistently.

The World Health Organization[4] in 2015 and the Centers for Disease Control (CDC)[3] in its Clinical Practice Guidelines of 2017 have strongly recommended the use of PrEP for high-risk groups (HRGs) of sexually active adult men who have sex with men (MSM), adult heterosexually active men and women, and injectable drug users (IDU), who are at substantial risk of HIV acquisition. For all the three groups, the indication for the use of PrEP is for those with a high number of sex partners or drug use partners, history of inconsistent condom use, HIV-negative partner of a serodiscordant couple, commercial sex partners, and/or residing in a high HIV prevalence area. Regular HIV and STI (syphilis, gonorrhea, and chlamydia) testing are required in all cases being administered PrEP.


  Use of Pre-Exposure Prophylaxis Top


PrEP has shown phenomenal success in recent years. Mathematical modeling suggests that approximately 2.7–3.2 million new HIV infections could be averted in southern sub-Saharan Africa over 10 years by targeting PrEP to those at the highest behavioral risk. In the USA, the risk group consists of MSM, whereas in Africa, it is being administered to young women. Globally, around 2.6% individuals or around 380,000 people in 68 countries,[7] with 60% of them in the USA, reported ever using PrEP with the odds of reporting doubling each year since 2012 ( P <.00001).[8] The awareness of PrEP is a concern for its use. A systematic review found that out of 23 studies involving 14,040 MSM from low- and medium-income countries, 29.7% (95% confidence interval [CI]: 16.9–44.3) were aware of PrEP. However, the proportion keen to use PrEP was found to be 64.4% (95% CI: 53.3–74.8).[9]

Although there has been a recent scale-up of PrEP in Africa, Australia, and Europe, India is still lagging behind, reporting only an estimated 600–800 users.[10] This may be because of the poor knowledge of PrEP among the general population and among health workers.[9] The access and availability of the drug, especially in India, is another issue. The use of PrEP has not been advocated by the National AIDS Control Organization in India.[6]


  Cost-Effectiveness of Pre-Exposure Prophylaxis Top


PrEP is more expensive than other HIV prevention methods such as the use of condoms. However, the overall cost-effectiveness of reducing the HIV burden has been proven to be higher with PrEP. Leech et al. concluded that PrEP has been found to be economically attractive and cost saving[11] in the US health-care sector. In another study conducted in Thailand, it was found that when incorporated with the ART program, PrEP use was cost-effective in the HRG of MSMs.[12] Truvada which is used in the USA and Europe costs around $2000 for a month's course,[13] and is costlier than the generic versions, approved in countries such as Australia and India. These countries have reduced prices of Truvada or have lower-priced, generic, imported brands.[14] Cipla[15] was the first company to get approval from the Drug Controller General of India to market Tenvir-EM (generic) in 2016. The price of Cipla Tenvir-EM is INR 2,500/, i.e., approximately $36 for 30 tablets, making the drug extremely low priced.


  Safety and Risks of Pre-Exposure Prophylaxis Top


Safety of PrEP is supported by three clinical trials; one carried out among MSM[16] in several countries, one among serodiscordant heterosexual couples,[17] and the other in young high-risk heterosexuals.[18] The drugs have been found to be well tolerated with mild side effects related to gastrointestinal intolerance, renal toxicity, and decreased bone density in patients with a comorbid condition.

Concerns of increased incidence of sexually transmitted diseases as a result of decreased condom use are the greatest fear of the use of PrEP.[1] Adherence to the drug is the other worry as users are required to take the drug daily for it to be effective and fear of drug resistance in such cases looms large.


  Ethico Social Challenges Top


HIV/AIDS has always been involved in ethical considerations and disagreements on human rights, testing policies, and questions on sexual morality. The introduction of PrEP into the prevention environment has further complicated the ethical issues with certain countries yet to introduce the PrEP into their national HIV policy. The safety, stigma, resistance to drugs, and diversions associated with an appropriate control arm while conducting a prevention trial in HIV/AIDS have been ethically challenging;[19] although based on the clinical trials, FDA approved the use of PrEP in high-risk groups of MSM, IDU users, and heterosexual female sex workers (FSWs).[3],[4]

The practical feasibility of administering PrEP in healthy populations becomes complicated when the high-risk group domain is that of heterosexual transmission. Although FSWs may be identified and regularly administered PrEP, it is difficult to identify the high-risk group of men who may be involved in regular visits of FSWs or frequent interactions with multiple casual sex partners.[4] This mode of transmission has been found to be the most common method of HIV transmission in India although reports of transmission through MSMs and IDUs are also seen.


  Pre-Exposure Prophylaxis in the Military Population Top


Not much data are available for use of PrEP in the military population. According to a study[20] conducted among the US Army personnel, where the requirement of PrEP was estimated using the risk assessment tools[21] developed by CDC for MSMs, approximately 2,000 US military personnel were prescribed PrEP although the requirement was estimated to be for 10,000 personnel. Risk assessment tools are available for HRGs of MSMs and young adult women and for FSWs. The Australian Defence Force[22] has recently facilitated the use of PrEP in the HRG without public funding. The high-risk group is to be assessed as per the Australian National guidelines. No data were found in the literature search from the military population of other countries.

In India, the mode of transmission of HIV/AIDS in the military in India is similar to that of the civil population, i.e., mostly through heterosexual transmission. For the administration of PrEP to prevent heterosexual transmission, the high-risk group identified is usually the FSWs or adult heterosexually active men with a high number of sex partners.[3] Identifying such an HRG cohort of military personnel involved with FSWs or multiple casual partners is difficult as the same is considered to be punishable if identified, and the visit to FSW is done surreptitiously. A post deputation medical examination including HIV screening is conducted for men returning from a foreign country. This cohort has also shown nil incidence of HIV due to extensive education before the induction and closer supervision and hence cannot be considered as a high-risk group. The Armed Forces personnel in India, thus, may not fall under any of the high-risk categories of MSM, heterosexual, or IDU and may not be eligible for the administration of PrEP as per the present WHO and CDC guidelines.[3],[4]


  Conclusion Top


The use of PrEP has been advocated as per the risk of transmission of the infection. It has been highly effective and successful when used in the HRG group of MSMs in the Western world and Australia and in young women in the African region. Not many studies have been conducted in other parts of the world.

Data available show that the Western military population has been using PrEP for the HRG of MSM to reduce the incidence of HIV in a well-trained but vulnerable population. The Australian defense forces have allowed the use of PrEP in the personnel without any public funding. However, in India, it is perceived that the risk factors of contracting the infection in the military population would be through FSWs and less through IDUs or MSMs, and hence, identifying populations who form the HRG engaging with FSWs would be a challenge.

PrEP, on the other hand, has been found to be effective, safe, and cost-effective. While implementing PrEP is complex, policymakers will need to debate more on the issue of expanding the scope of delivering PrEP in combination with the social drivers of HIV vulnerability specific to each population. Millions of dollars have been spent on several vaccination programs, but the administration of vaccines to HIV-negative healthy population would also face the same dilemma of identifying appropriate risk groups.

Inability to implement PrEP may be considered as a failure to protect those who could have been prevented from HIV. Whether PrEP can become a game changer, will depend on successfully addressing how to introduce the drug into national programs. The Armed Forces policymakers may follow suit.



 
  References Top

1.
Gandhi M, Spinelli MA, Mayer KH. Addressing the sexually transmitted infection and HIV syndemic. JAMA 2019;321:1356-8.  Back to cited text no. 1
    
2.
The Global HIV/AIDS Epidemic. Henry Kaiser Family Foundation. Available from: https://www.kff.org/global-health-policy/fact-sheet/the-global-hivaids-epidemic/. [Last accessed on 2019 Mar 14].  Back to cited text no. 2
    
3.
US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update, a Clinical Practice Guideline. Available from: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. [Last accessed on 2019 Apr 13].  Back to cited text no. 3
    
4.
World Health Organization. Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. World Health Organization; 2015. Available from: https://apps.who.int/iris/bitstream/handle/10665/186275/9789241509565_eng.pdf?sequence=1. [Last accessed on 2019 Apr 30].  Back to cited text no. 4
    
5.
Global Statistics. Available from: https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics. [Last accessed on 2019 Apr 13].  Back to cited text no. 5
    
6.
National Technical Guidelines on Anti Retroviral Treatment. NACO; October, 2018. Available from: http://naco.gov.in/sites/default/files/NACO%20-%20National%20Technical%20Guidelines%20on%20ART_October%202018%20%281%29.pdf. [Last. [Last accessed on 2019 Apr 13].  Back to cited text no. 6
    
7.
380,000 People on PrEP Globally, Mostly in the USA and Africa. Available from: http://www.aidsmap.com/300000-people-on-PrEP-globally-mostly-in-the-USA-and-Africa/page/3357159/. [Last accessed on 2019 Apr 13].  Back to cited text no. 7
    
8.
PrEP Use Growing in the US and Worldwide. Available from: https://www.theaidsreader.com/hiv-aids/prep-use-growing-us-and-worldwide. [Last accessed on 2019 Mar 14].  Back to cited text no. 8
    
9.
Yi S, Tuot S, Mwai GW, Ngin C, Chhim K, Pal K, et al. Awareness and willingness to use HIV pre-exposure prophylaxis among men who have sex with men in low- and middle-income countries: A systematic review and meta-analysis. J Int AIDS Soc 2017;20:21580.  Back to cited text no. 9
    
10.
Pre Exposure Prophylaxis Watch. Available from: https://www.prepwatch.org/country/india/. [Last accessed on 2019 May 03].  Back to cited text no. 10
    
11.
Leech AA, Burgess JF, Sullivan M, Kuohung W, Horný M, Drainoni ML, et al. Cost-effectiveness of preexposure prophylaxis for HIV prevention for conception in the United States. AIDS 2018;32:2787-98.  Back to cited text no. 11
    
12.
Suraratdecha C, Stuart RM, Manopaiboon C, Green D, Lertpiriyasuwat C, Wilson DP, et al. Cost and cost-effectiveness analysis of pre-exposure prophylaxis among men who have sex with men in two hospitals in Thailand. J Int AIDS Soc 2018;21 Suppl 5:e25129.  Back to cited text no. 12
    
13.
Cost of HIV Prevention Drug Discouraging People from Doing PrEP Therapy. Available from: https://www.healthline.com/health-news/cost-of-hiv-prevention-drug-discouraging-people-from-doing-prep-therapy#1. [Last accessed on 2019 May 05].  Back to cited text no. 13
    
14.
Subsidy for HIV Prevention Drug PrEP to Slash Cost from $10,000 a Year to $474. Available from: https://www.theguardian.com/australia-news/2018/feb/08/hiv-prevention-drug-prep-likely-to-be-approved-for-federal-subsidy. [Last accessed on 2019 May 05].  Back to cited text no. 14
    
15.
Cipla Gets Approval to Sell its Version of Truvada in India. Available from: https://www.thehindubusinessline.com/companies/cipla-gets-approval-to-sell-its-version-of-truvada-in-india/article8637483.ece. [Last accessed on 2019 May 01].  Back to cited text no. 15
    
16.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363:2587-99.  Back to cited text no. 16
    
17.
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367:399-410.  Back to cited text no. 17
    
18.
Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012;367:423-34.  Back to cited text no. 18
    
19.
Sugarman J, Mayer KH. Ethics and pre-exposure prophylaxis for HIV infection. J Acquir Immune Defic Syndr 2013;63 Suppl 2:S135-9.  Back to cited text no. 19
    
20.
Blaylock JM, Hakre S, Okulicz JF, Garges E, Wilson K, Lay J, et al. HIV preexposure prophylaxis in the U.S. military services – 2014-2016. MMWR Morb Mortal Wkly Rep 2018;67:569-74.  Back to cited text no. 20
    
21.
Oral Risk Assessment Tools. Available from: https://www.prepwatch.org/risk-assessment-tools/. [Last accessed on 2019 May 02].  Back to cited text no. 21
    
22.
PrEP Treatment Options for Defence Personnel Clarified. Available from: https://www.defglis.com.au/index.php/news/219-prep-treatment-options-for-defence-personnel-clairifed. [Last accessed on 2019 May 10].  Back to cited text no. 22
    




 

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Introduction
Use of Pre-Expos...
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Safety and Risks...
Ethico Social Ch...
Pre-Exposure Pro...
Conclusion
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