Prepex

PrePex
Launch year 2009
Company PrePex
Availability Available in Sub-Saharan Africa
Website www.prepex.com

PrePex is a medical device developed to facilitate non-surgical voluntary medical male circumcision (VMMC) of adults as part of a comprehensive HIV prevention strategy in Sub-Saharan Africa.

History

PrePex was developed in 2009 shortly after the World Health Organization (WHO) published substantial research concluding that men in Sub-Saharan Africa can significantly reduce their risk of contracting HIV, the virus that leads to AIDS, and other sexually transmitted diseases, by undergoing circumcision.[1] [2] UNAIDS, in partnership with the President's Emergency Plan for AIDS Relief, the Bill & Melinda Gates Foundation, WHO and the World Bank, announced an accelerated plan to scale up VMMC to reach approximately 20 million men by the year ending 2015, saving roughly 3.4 million lives and $16.5 billion.[3]

Usage

The device is disposable and comprises four elements: a placement ring, an inner ring, an elastic ring and a verification thread. The device stops the flow of blood and oxygen to the foreskin tissue, initiating ischemic necrosis through the use of an elastic ring controlled radial compression.[4] The dead tissue naturally detaches or is easily removed after 7 days.[5] The procedure has been clinically validated and peer reviewed as safe in the hands of trained nurses, who conduct the bloodless procedure in non-sterile settings in less than five minutes, without the need for injected anesthesia or sutures.[6] The device is not for self-use, and is only intended for males aged 18 years or older.[7]

Device and commendations

The PrePex device is cleared by the U.S. Food and Drug Administration (FDA), certified Mark Class IIa device and is available for adult men.[8] The device is patent pending, and has been extensively reviewed by the WHO, with its safety and efficacy validated in a series of studies.[9] [10] Circ MedTech is ISO 13485 certified.

In April 2012, PrePex won the Best Technology for Health Award and was tested and reviewed favorably by the WHO’s Technical Advisory Group on Innovations in Male Circumcision.[11][12]

In March 2013, Tzameret Fuerst, former CEO of Circ MedTech, presented the PrePex device at the AIPAC Policy Conference in Washington DC.[13][14]

In May 2013, after the WHO prequalified the PrePex device, the U.S. Global AIDS Coordinator, Ambassador Eric Goosby, stated, that “PEPFAR [was] ready to support countries that wish to introduce PrePex right away. This will truly help save lives.”[15]

Treatment and efficacy

Male circumcision as HIV prevention

According to the WHO and UNAIDS, there is compelling evidence that male circumcision reduces the risk of heterosexually acquired HIV infection in men by about 60%. The WHO and UNAIDS recommendations emphasize that male circumcision should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, a high incidence of HIV and low prevalence of male circumcision.[1]

The extensive research on the benefits of male circumcision provided the impetus to add VMMC to the PEPFAR Blueprint in order to achieve an AIDS-free generation as declared by the President of the United States, Barack Obama, in his speech on World AIDS Day, December 1, 2011.[16]

On November 8, 2011, United States Secretary of State, Hillary Rodham Clinton had cited male circumcision as one of the key elements in achieving that goal: "In the fight against AIDS, the ideal intervention is one that prevents people from being infected in the first place, and the two methods I’ve described--mother-to-child transmission, voluntary medical male circumcision--are the most cost-effective interventions we have, and we are scaling them up."[17]

Current utilization

PrePex is being used for non-surgical adult male circumcision for HIV prevention in 16 priority countries in Sub-Saharan Africa with high HIV prevalence and, as such, the device is not yet available elsewhere.[18]

Those 16 priority countries set by the WHO for VMMC include: Botswana, Central African Republic, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, South Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.[19]

According to UNAIDS 2013 global report on the AIDS epidemic, as of December 2012, 3.2 million African men had been circumcised through specific services for VMMC. The intention of the PrePex device is to accelerate scale-up of VMMC by providing men with an alternative to surgical circumcision and by relieving demands on the limited number of surgeons available in priority countries.[20]

The device is being scaled up in Rwanda[21] and Zimbabwe[22] following pilot studies that were funded by the Bill & Melinda Gates Foundation and PEPFAR. Other countries are in pilot stages and are expected to start scale-up of VMMC with PrePex in the latter part of 2014.

Peer-reviewed clinical data

The PrePex device was validated for safety and efficacy by the Government of Rwanda as detailed in the Journal of Acquired Immune Deficiency Syndromes (JAIDS) on September 8, 2011.[JAIDS 1] The study was reviewed onsite by WHO and Gates Foundation delegates.

A second study was designed to compare a new non-surgical device with surgical MC to assess non-surgical MC suitability for scale-up. It used a randomized and controlled trial where the PrePex device was compared to the dorsal slit method of circumcision, focusing on adult males aged 21–54, finding that the mean time for a non-surgical PrePex procedure was about 1/5 shorter in duration (3.1 minutes compared to 15.4 minutes). [JAIDS 2]

A third study examined the efficacy and of the PrePex device when circumcision was performed by nurses, finding that training was quick, easy and sufficient to ensure effective procedures.[JAIDS 3]

Elements of HIV prevention

Male circumcision provides only partial protection and therefore should be only one element of a comprehensive HIV prevention package which includes the provision of HIV testing and counseling services, treatment for sexually-transmitted infections, the promotion of safer sex practices, the provision of male and female condoms and the promotion of their correct and consistent use.[1]

Some studies have warned of caution being necessary when carrying out any scale-up of circumcision, particularly warning newly circumcised males (surgical or non-surgical) to refrain from sexual activity until the wounds are fully healed. In addition, that circumcised men might have a false sense of security that could lead to increased risky sexual behavior.[23]

References

  1. 1 2 3 "Male circumcision for HIV prevention". WHO. Retrieved 8 April 2014.
  2. ↑ Park, Alice (17 April 2013). "Why Circumcision Lowers Risk of HIV". Time Magazine. Retrieved 8 April 2014.
  3. ↑ "International partners call for accelerated access to voluntary medical male circumcision in eastern and southern Africa". UNAIDS. Retrieved 8 April 2014.
  4. ↑ Farley, Tim. "Adult Male Circumcision Devices". PowerPoint Presentation. World Health Organization. Retrieved 30 May 2014.
  5. ↑ "Clinical Procedure". Prepex. Retrieved 20 April 2014.
  6. ↑ "Non-surgical male circumcision device" (PDF). WHO Medical Devices. WHO. Retrieved 20 April 2014.
  7. ↑ "9 studies found for PrePex". ClinicalTrials.gov. Retrieved 20 April 2014.
  8. ↑ "501(K) Summary for PrePex" (PDF). FDA. Retrieved 30 May 2014.
  9. ↑ "WHO Prequalification of Male Circumcision Devices Public Report - Product: PrePex" (PDF). WHO. Retrieved 30 May 2014.
  10. ↑ "CIRCUMCISION DEVICE AND METHOD FOR MASS CIRCUMCISION". Espacenet Patent Search. Retrieved 20 April 2014.
  11. ↑ "Technology for Health 2012 Winner: PrePex by Circ MedTech" (PDF). GBC Health. Retrieved 20 April 2014.
  12. ↑ "WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of Two Adult Devices" (PDF). WHO. Retrieved 20 April 2014.
  13. ↑ "Women in Israel 2014". Israel Ministry of Foreign Affairs. Retrieved 2 August 2015.
  14. ↑ Klein Leichman, Abigail. "AIPAC Innovation Showcase brings ISRAEL21c’s stories to life". Israel21c. Retrieved 2 August 2015.
  15. ↑ "Statement by the Office of the U.S. Global AIDS Coordinator (OGAC) on World Health Organization Prequalification of First Medical Device for Adult Voluntary Medical Male Circumcision". The United States President's Emergency Plan for AIDS Relief. Retrieved 20 April 2014.
  16. ↑ "PEPFAR Blueprint: Creating an AIDS-Free Generation" (PDF). President's Emergency Plan for AIDS Relief. Retrieved 30 May 2014.
  17. ↑ "Secretary Clinton’s Remarks on Creating AIDS-Free Generation". U.S. DEPARTMENT OF STATE Office of the Spokesperson. Retrieved 30 May 2014.
  18. ↑ McNeil, Donald G., Jr. (Aug 13, 2012). "Africa: Nonsurgical Circumcision Device Will Be Tested to Help Curb AIDS". The New York Times. Retrieved 30 May 2014.
  19. ↑ "Progress in scale-uP of male circumcision for HiV PreVention in eastern and soutHern africa: Focus on service delivery" (PDF). WHO. Retrieved 30 May 2014.
  20. ↑ "UNAIDS report on the global AIDS epidemic 2013" (PDF). UNAIDS.
  21. ↑ "Rwanda Becomes the First Country to Launch Nationwide Scale-Up of Non-Surgical Adult Male Circumcision to Reduce HIV Infection" (PDF). Republic of Rwanda Ministry of Health. Retrieved 30 May 2014.
  22. ↑ "Zimbabwe: Govt to introduce less painful male circumcision". Southern Africa HIV and AIDS Regional Exchange. Retrieved 30 May 2014.
  23. ↑ Kalichman, Seth; Lisa Eaton; Steven Pinkerton (March 2007). "Circumcision for HIV Prevention: Failure to Fully Account for Behavioral Risk Compensation". PLoS Medicine 4 (3): 138. doi:10.1371/journal.pmed.0040138. PMC 1831748. PMID 17388676.

JAIDS references

  1. ↑ Bitega, Jean Paul; Ngeruka, Muyenzi Leon; Hategekimana, Theobald; Asiimwe, Anita; Binagwaho, Agnes (December 15, 2011). "Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings". Journal of Acquired Immune Deficiency Syndromes 58 (5): 127–134. doi:10.1097/QAI.0b013e3182354e65. Retrieved 30 May 2014.
  2. ↑ Mutabazi, Vincent MD; Kaplan, Steven A. MD; Rwamasirabo, Emile MD; Bitega, Jean Paul MD; Ngeruka, Muyenzi Leon MD; Savio, Dominique MD; Karema, Corine MD; Binagwaho, Agnes MD (September 1, 2012). "HIV Prevention: Male Circumcision Comparison Between a Nonsurgical Device to a Surgical Technique in Resource-Limited Settings: A Prospective, Randomized, Nonmasked Trial". Journal of Acquired Immune Deficiency Syndromes 61 (1): 49–55. doi:10.1097/QAI.0b013e3182631d69. Retrieved 30 May 2014.
  3. ↑ Mutabazi, Vincent MD; Kaplan, Steven A. MD; Rwamasirabo, Emile MD; Bitega, Jean P. MD; Ngeruka, Muyenzi L. MD; Savio, Dominique MD; Karema, Corine MD; Binagwaho, Agnes MD (July 1, 2013). "One-Arm, Open-Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale-Up of Nonsurgical Circumcision When Performed by Nurses in Resource-Limited Settings for HIV Prevention". Journal of Acquired Immune Deficiency Syndromes 63 (3): 315–322. doi:10.1097/QAI.0b013e31828e6412. Retrieved 30 May 2014.
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