Since HIV/AIDS has no cure or vaccine, prevention of new HIV infection remains an important strategy towards ending HIV and AIDS. Effective HIV prevention response needs to consider the various underlying biological, behavioral, sociocultural, economic, political, legal, and other contextual factors.
In recognition of this, Zanzibar implements combination prevention interventions, which include biomedical interventions, such as proper and consistent use of male and female condoms, screening and treatment of sexual transmitted infections(STIs),Post-Exposure Prophylaxis(PEP), and safer conception choices for HIV positive mothers or women of the childbearing age group who are in sero-discordant relationships and Pre-Exposure Prophylaxis(PrEP),a newly introduced biomedical tool for preventing primary HIV infection among individuals with a substantial ongoing risk of HIV, such as key and vulnerable populations.
Pre-Exposure Prophylaxis (PrEP)
Pre-Exposure Prophylaxis (PrEP) is the use of antiretroviral drugs (ARVs) by people who do not have HIV infection in order to prevent the acquisition of HIV.WHO recommends that oral PrEP containing tenofovir disoproxil fumarate (TDF) should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV approaches. These populations include Men who have Sex with Men (MSM), Female Sex Workers (FSW), People Who Inject Drugs (PWID), and discordant couples. However, PrEP should not replace or compete with effective and well-established HIV prevention interventions, such as comprehensive condom programming for sex workers and men who have sex with men and harm reduction for people who inject drugs.
PrEP Target Populations
The target population for PrEP in Zanzibar currently include the following
- Key population (i.e., sex workers, men who have sex with men, and people who inject drugs).
- HIV negative partners in sero-discordant relationships (i.e., when an HIV infected partner is not on ART or is on ART for less than six months or has not attained viral suppression less than 50copies/ml). This includes HIV negative pregnant and breastfeeding mothers in a sero-discordant relationship.
PrEP Eligibility Criteria
- HIV seronegative as per the current national testing algorithm
- No suspicion of acute HIV infection
- Age greater than or equal to 15 years
- Willing to use PrEP as prescribed
- Willing to stop PrEP when no longer eligible
- No contraindications PrEP medicines (TDF/FTC), including having creatinine clearance > 60ml/min**
Having a substantial risk of HIV acquisition, defined as engaging in one or more of the following activities within the last six months:
- Vaginal or anal sex without a condom with more than one partner or,
- History of a new sexually transmitted infection or,
- Use of post-exposure prophylaxis for sexual exposure or,
- Has a known HIV positive sexual partner(s) who is not on ART/ on ART less than six months or refuses to report a risk category but still request PrEP
Clients Ineligible for PrEP
- HIV positive status ‘OR’ Unknown HIV status
- Sign/symptoms of acute HIV Infection (AHI), probably recent exposure to HIV
- Known renal impairment or estimated creatinine clearance <60ml/min (if known)
- Significantly mobile persons who will not be able to attend visits as per prescribed. For example:
- Clients who will not be in a region where PrEP can be provided at the next visit
- Clients who do not have contact information
- Unwilling/unable to take daily medication
- Allergy or contraindication to any medication within PrEP regimen
Preferred ARV PrEP regimens
The recommended PrEP regimen is Emtricitabine (FTC) 200mg/Tenofovir Disoproxil Fumarate (TDF) 300mg (Truvada) taken orally once daily.
Indications for PrEP Discontinuation
Individuals taking PrEP require an ongoing risk assessment, and PrEP can be discontinued if individuals acquire HIV infection, are no longer substantial risk for HIV infection or decide to use other effective prevention methods or poor adherence or severe side effects/adverse events.
Note: PrEP should be provided for at least 28 days after the last possible exposure to HIV.
PrEP Service Delivery Modality
PrEP can be provided both at health facilities or MOH-approved community locations/hotspots. PrEP should be provided as part of a comprehensive prevention package of interventions.
In the United States, federal guidelines recommend the use of pre-exposure prophylaxis (PrEP) for HIV-negative adults with the following characteristics:
- sexually active in the last 6 months and NOT in a sexually monogamous relationship with a recently tested HIV-negative partner, and who
- is a (MSM), and who…
- has had anal sex with another man in the past 6 months without a condom, or…
- has had a STI in the past 6 months
- or is a sexually active adult (male or female with male or female partners), and who…
- is a man who has sex with both men and women, or…
- has sex with partners at increased risk of having HIV (e.g. injection drug users, men who have sex with men) without consistent condom use
- is a (MSM), and who…
- or anyone who has injected illicit drugs in the past six months, shared recreational drug injection equipment with other drug users in the past six months, or who has been in treatment for injection drug use in the past six months
In the United Kingdom the BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PrEP) 2018 recommend:
- On-demand or daily oral Tenofovir-emtricitabine (TD-FTC) for HIV-negative MSM who are at elevated risk of HIV acquisition through unprotected anal sex in the previous 6 months and ongoing unprotected anal sex.
- On-demand or daily oral TD-FTC for HIV-negative MSM having unprotected anal sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.
- Tenofovir (TDF) alone should not be offered to MSM.
- Daily oral TD-FTC for HIV-negative heterosexual men and women having unprotected sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.
- Daily oral TD-FTC for heterosexual men and women on a case-by-case basis with current factors that may put them at increased risk of HIV acquisition.
- TDF alone can be offered to heterosexual men and women where FTC is contraindicated.
- PrEP is not recommended for people who inject drugs where needle exchange and opiate substitution programs are available and accessed by the individual.
- PrEP with daily oral TD-FTC for HIV-negative trans women who are at risk of HIV acquisition through unprotected anal sex in the previous 6 months and ongoing unprotected sex.
- Daily oral TD-FTC for HIV-negative trans women and trans men who have unprotected sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.
Research shows that pre-exposure prophylaxis (PrEP) is generally safe and well tolerated for most individuals, although some side effects have been noted to occur. Some people experience a “start-up syndrome” involving nausea, headache, and/or stomach issues, which generally resolve within a few weeks of starting the PrEP medication.
Research has shown that the use of Truvada as PrEP has been associated with mild to moderate declines in kidney function, mostly associated with older people over 50, those with predisposing conditions such as diabetes, or glomerular filtration rate lower than 90.These declines were usually of no concern, stabilized after several weeks of being on the drug, and reversed once the drug was discontinued.
However, these side effects were serious enough for several people on PrEP to file lawsuits against the makers of Truvada as well as the makers of other similar drugs.
Osteopenia or bone loss has been reported in clinical studies. Bone loss was not seen as a major concern for ending the service since bone loss was considered minimal and did not lead to osteoporosis. When comparing bone fractures between active participants and control there was no major difference in bone fractures.
Fat redistribution and accumulation was more commonly seen in individuals receiving antiretroviral therapy, particularly older antiretrovirals, for the treatment of HIV.
No significant changes in fat redistribution or change in fat had been noted as of February 2018 when used as a pre-exposure prophylaxis. Research and study outcome analysis suggests that emtricitabine/tenofovir does not have a significant effect on fat redistribution or accumulation when used as pre-exposure prophylaxis in HIV negative individuals. As of early 2018 these studies have not assessed in detail subtle changes in fat distribution that may be possible with the drug when used as PrEP, and statistically significant – though transient – weight changes have been attributed to detectable drug concentrations in the body.
Other potential serious side effects of Truvada include acute exacerbations of hepatitis B in individuals with HBV infection, Lactic acidosis, and severe hepatomegaly with steatosis.
Descovy research and data from public use has shown similar “start-up” effects; however, some data indicates that Descovy is better for one’s kidneys and for those with a diagnosis of osteoporosis.