On a stormy november night, I headed for Antwerp, where the Institute of Tropical Medicine held an evening seminar on the latest in the field of combination prevention and HIV-therapy. Sandra Van den Eynde (Sensoa) and Eric Florence (ITG) updated us on the take-home messages and news from the international STD-HIV-AIDS-congresses held in 2015/2016. I will share with you the top 5 topics I think you should know about when involved in reproductive health. You can download the presentations here.
1 Risk of transmission of HIV: ZERO?
Serodiscordant couples are couples of which one the partners is HIV infected (seropositive) and the other is not (seronegative). For a long time, one of the burning questions has been what the transmission risk is in these couples. The good new is that we are getting closer to finding answers.
Last summer, the results of the so called PARTNER-study were presented at the AIDS 2016 conference in Durban, South Africa. The PARTNER-study is a prospective, observational study into the transmission risk in serodiscordant couples who have condomless sexual activity while the HIV-positive partner is on antiretroviral therapy (ART, which suppresses the virus). The study was conducted at 75 clinical sites in 14 European countries and 1166 HIV serodiscordant couples of which the infected partner had a HIV-1 RNA load of less than 200 copies/mL were enrolled.
The promising outcome is that there were no documented cases of within-couple HIV transmission. Of course this result comes with the disclaimer that additional longer-term follow-up studies are needed to give more exact estimates of the risk. However, these first findings might be an important step in using ART as a prevention strategy in serodiscordant couples who have condomless sex. This might give interesting prospects to increase the options for serodiscordant couples who are trying to conceive.
2 The 90 – 90 – 90 target
In 2014, the United Nations Program on HIV/AIDS (UNAIDS) set some firm targets for countries to be reached by 2020, on the way to putting an end to the AIDS epidemic by 2030. It might be good to put them in the spotlight once more. UNAIDS asks that by 2020, countries will have diagnosed 90% of all HIV-positive patients in their population, will have 90% of the diagnosed on treatment and will have reached a fully suppressed viral load in 90% of those on treatment.
There is good progress where the treatment coverage of people who have been diagnosed with HIV is concerned, but there is still a world to win in getting people diagnosed and preventing further spreading. Of all people with HIV 46% is still not aware of their status. There are two innovations that might contribute to an increase in both prevention and diagnosis that you should know about. One is PrEP, the other is HIVST.
3 Be PrEP-ared
Pre-Exposure Prophylaxis - PrEP - is a means of protecting oneself against being infected with HIV by taking antiretroviral medication on a daily basis. The target group for PrEP are those who run an ongoing high risk of being infected with HIV. PrEP usually refers to a pill combining Tenofovir and Emtricitabine, but a vaginal gel containing Tenofovir also exists. In the United States, the Food and Drug Administration has approved Truvada as a drug for PrEP while several other countries, including Belgium and The Netherlands, are currently conducting trials.
Studies among different populations have shown that if PrEP is taken orally on a daily basis, it reduces the risk of being infected with HIV in high risk groups by more than 90%. Crucial to the success however, is that patients commit themselves to taking their medication daily and see their doctor on a regular basis. Combining PrEP with other means of preventing new infections can enhance its effectiveness even more. According to the WHO the vaginal gel is only moderately effective.
As for the safety of PrEP, no serious side effects were reported in clinical studies. Some of the participants experienced early temporary side effects (upset stomach, loss of appetite), others a mild headache.
PrEP and pregnancy
Enabling the couple to make well informed decisions, is key here. When a serodiscordant heterosexual couple wants to have a baby, they need to be thoroughly informed about the pros and cons of all measures for safer conception (and regardless of what they choose, the infected partner should always receive antiretroviral therapy before trying to conceive).
The range of possible measures includes the periconceptional use of PrEP as an additional means of protecting the uninfected partner, since the antiretroviral therapy of the infected partner may not protect fully against sexually transmitting the virus. This goes especially for uninfected women with an infected partner, who run a significant risk of being infected themselves when trying to conceive. Furthermore, pregnancy is associated with a higher risk of contracting HIV.
If it is the female partner taking PrEP, she needs to be aware that is still unclear whether it affects her unborn child since the available evidence is limited. Whether it is safe for a mother on PrEP to breastfeed her child, still needs to be studied.
4 HIV selfie
Another suggested way to achieve the 90-90-90 goal, is the HIV self-testing (HIVST). HIV self-testing is defined as “a process in which people can collect their own specimen (saliva or blood), perform a test and interpret the result, often in private or with someone they trust” (WHO, 2013). It has to be emphasised that self-testing does not provide a HIV-positive diagnosis. In case of a positive test, a diagnostic test at a health facility is still required.
Self-testing might have a huge potential to reach vulnerable populations that would otherwise not be tested. Globally, close to 60% of new HIV infections occur in adolescent girls. This group in the reproductive age is often less likely to be tested at standard health facilities due to barriers such as stigma, shame, privacy, discrimination, age of consent laws or simply limited access to testing facilities. This means that they are unaware of their status and therefore not receiving antiretroviral therapy (ART) timely. In the meanwhile they can, unknowingly, continue to transmit HIV to their partner or unborn child.
It might not come as a surprise that there is an increasing demand for medical self-testing, and an increasing number of companies trying to respond to it. An overview of HIV Rapid Diagnostic Tests (RDT) for self-testing that are currently on the market can be found here. It concerns fingerstick/whole blood based and oral fluid based HIV RDTs for self-testing.
About sixteen countries have adopted HIV self-testing policies (although not all have already implemented them). For instance, in Brazil there are oral fluid-based self-tests and in Thailand fingerstick blood-based self-tests, while in Zimbabwe and South-Africa oral fluid-based tests are part of ongoing implementation studies on reaching other than key populations, like young people. One of those projects is Self-Testing Africa (STAR), a four year study of UNITAID in which several models of test-kit distributions are evaluated in three countries with a high HIV burden: Zimbabwe, Malawi and Zambia. This clip gives an idea of the work being done in Malawi for the STAR project:
As of the coming week, inhabitants of Belgium will be able to test themselves for HIV with the so called Autotest VIH, developed by Mylan. The test will be launched on Wednesday, November 23, and will be available through pharmacies without a doctor's prescription. The Autotest VIH is a second generation test with 100% sensitivity and 99,8% specificity. The test is CE marked and submitted for WHO prequalification and will be available for a little less than 30 euros.
The Autotest VIH is an orientational test that detects antibodies to HIV 1 and 2 in human blood in case of an infection. The window period is three months, instead of the six weeks for regular tests by the general practitioner (GP). As mentioned above, if the test indicates an infection, one should go the GP and have the outcome confirmed through a regular test (Elisa). The same, by the way, goes for a negative result if the person taking the test showed sexual risk behavior in the window period or was unintentionally exposed to risks. To ensure a reliable outcome, the instructions have to be strictly followed. They are explained in a tutorial:
For all its promises, the introduction of HIV self-testing doesn’t go without debate. During the first international symposium on self-testing for HIV in 2013 (WHO, Geneva), the legal, ethical and public health implications of self-testing scale up were discussed.
Currently, the leading principle in the fight against the HIV epidemic is “test and treat”. For a variety of reasons, however, those who test positive in a self-test, do not always go straight to their GP, which might delay (or even avert) both the confirmation test and the immediate start of ART treatment. Furthermore, the GP is the gatekeeper who informs the patient about the results, puts them into context (a negative HIV-test doesn’t exclude other STD’s, while a positive result isn’t a death sentence), discusses risk behavior during the window period, et cetera. These matters need to be addressed properly and quickly, which is unlikely to happen in case of a delayed or averted visit to the GP.
In December 2016, the WHO will release a HIVST guidance with normative guidelines on HIV self-testing. You can follow these developments here.
5 Stay Tuned
The Institute of Tropical Medicine in Antwerp organises an evening course for medical doctors, midwives, nurses and medical students and teachers on HIV Care and Prevention during springtime (12 evenings from March to June 2017). The HIV-plan Belgium 2014 - 2019 will be the guiding document during the course as it is an instrument in reaching the 90-90-90 target in Belgium. For more information on the classes, check the course page. We were told that unless Obama enrolls, the course will be taught in Dutch. Can someone please invite Obama?
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Powerpoints of the evening seminar “Combination prevention & HIV-therapy anno 2016: what is new?, 17 november 2016, at the Institute of Tropical Medicine. See: http://www.itg.be/itg/GeneralSite/Default.aspx?WPID=702&MIID=642&L=E
Joint United Nations Programme on HIV/AIDS (UNAIDS) (2014). Report: 90-90-90 – An Ambitious Treatment Target to Help End the AIDS Epidemic. UNAIDS / JC2684. See: http://www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf
UNITAID (2016). Technology Landscape. HIV Rapid Diagnostic Tests For Self-Testing, 2nd Edition, July 2016. See: http://www.aidsdatahub.org/sites/default/files/publication/UNITAID_HIV_rapid_diagnostic_tests_for_self-testing_2016.pdf
Rodger, A.J., Cambiano, V., Bruun, T., et al. (2016). Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy, JAMA, 316(2):171-181. doi:10.1001/jama.2016.5148, see: http://jamanetwork.com/journals/jama/article-abstract/2533066
Abstracts of the AIDS 2016, Durban Conference, see: http://programme.aids2016.org/Abstract/Index
WHO, UNAIDS, Brocher Foundation, LSTM. (2013). Report on the first international symposium on self-testing for HIV: The legal, ethical, gender, human rights and public health implications of self-testing scale-up. Meeting report - Geneva, Switzerland. 8-9 April 2013. See: http://apps.who.int/iris/bitstream/10665/85267/1/9789241505628_eng.pdf?ua=1
CDC, PreEP Information Sheet, Frequently Asked Questions, nr CS246841-A. See: http://www.cdc.gov/hiv/pdf/prep_gl_patient_factsheet_prep_english.pdf
US Public Health Service (2014). Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - A Clinical Practice Guideline, p. 40 - 41. See: http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
US Public Health Service (2014). Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - Clinical Providers’ Supplement, p. 14 - 17. See: http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf
Centers for Disease Control and Prevention on PrEP http://www.cdc.gov/hiv/risk/prep/index.html
Site of the US Federal government providing HIV/AIDS related information. www.aids.gov
World Health Organisation on HIVST http://www.who.int/hiv/mediacentre/news/hiv-self-testing-2016/en/
CCO provides resources for healthcare providers in different areas, among others in the area of HIV http://www.clinicaloptions.com/HIV.aspx
Hivandheptatitis provides information about treatment, management, and prevention of HIV, hepatitis B and C, HIV/HBV and HIV/HCV coinfection, and related conditions http://hivandhepatitis.com/hiv-aids
Online Center for Public Health Research, documentation and policies regarding HIV Self-testing www.hivst.org