14. How do I assess for adherence?
Strict adherence to PrEP is critical for maximum efficacy. This should be evaluated at the initial visit and at follow-up appointments.
The likelihood of adhering should be assessed at the initial visit with questions such as, “Can you commit to take a pill every day?”.
- For MSM who state that they cannot commit to taking a pill every day, on-demand dosing is an option if sexual exposures are infrequent. Assess likelihood of adherence by asking the patient to articulate how and when they will take 2-1-1 dosing and what they will do if consecutive sexual contacts occur.
Adherence at follow-up visits should also be evaluated, for example by asking, “Over the past four days, how many doses of PrEP have you taken?”.
- For MSM patients using 2-1-1 dosing, at follow-up visits, consider asking them to explain how they took PrEP for their last sexual encounter.
15. What HIV tests are recommended for HIV screening?
As described in Q9, excluding HIV infection prior to starting PrEP is critically important. TDF-FTC as PrEP does not constitute a full HIV treatment regimen, so patients with HIV who are on PrEP are at risk of developing a resistant strain. HIV testing should be conducted immediately prior to starting PrEP, ideally the same day the prescription is provided. DHSP recommends using a lab-based fourth-generation (preferred) or viral load due to increased sensitivity for acute HIV, however, CDC states that any HIV test (except an oral rapid test) can be used for the baseline HIV testing. For a list of FDA-approved third- and fourth-generation tests and other testing resources, visit https://www.cdc.gov/hiv/testing/laboratorytests.html.
If the patient has symptoms of acute HIV infection or risk factors for acute HIV infection a nucleic acid amplification test (NAAT, viral load) should be performed. PrEP should not be started unless the result is negative.
Symptoms of acute HIV are fever, swollen lymph nodes, sore throat, myalgia, and arthralgia, and risk factors include unprotected sex or sharing needles.
For more information on HIV, including detection of acute HIV, visit the CDC STD Treatment Guidelines, section HIV Infection: Detection, Counseling, and Referral.
16. What if my patient reports recent high-risk exposure?
Patients who report any high-risk exposures within the last month should first be evaluated for symptoms or signs of acute HIV infection: fever, swollen lymph nodes, sore throat, myalgia, and arthralgia. If the patient has had signs or symptoms suggestive of acute HIV in the past month, the patient should be evaluated for HIV and PrEP initiation deferred (see Q17).
If the exposure was in the past 72 hours, offer Post-Exposure HIV Prophylaxis (PEP) (see the CDC Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV). If the exposure was >72 hours (therefore PEP not recommended), the patient has no signs or symptoms of HIV in the past 4 weeks, tests HIV negative, and the risk of HIV acquisition is ongoing, PrEP should be offered.
17. If my patient reports recent symptoms suggestive of acute HIV, can I still start PrEP?
No. PrEP initiation should be deferred until HIV infection is ruled out.
CDC Guidelines suggest the following options for patients with signs and/or symptoms of acute HIV infection within the prior four weeks (see algorithm on p. 41 of the CDC PrEP Guidelines).3
- Option 1 - Retest in one month; defer decision to start PrEP.
- Option 2 - Send blood for HIV antibody/antigen assay (i.e., fourth generation HIV testing). If the patient is negative, it is acceptable to initiate PrEP.
- Option 3 - Send blood for HIV-1 viral load (VL) assay.
- If the patient has VL<50,000 copies/mL, PrEP should be deferred while testing is repeated.
- If the VL is undetectable and the patient has no signs/symptoms the day of the blood draw, it is acceptable to initiate PrEP.
- If the VL is undetectable and the patient has signs/symptoms the day of the blood draw, retest in one month and defer decision on PrEP.
- If the patient has VL >50,000, they are HIV-infected and are not eligible for PrEP.
18. How should daily PrEP be discontinued?
If daily PrEP is to be discontinued, the patient should continue to take daily TDF/FTC for 1 week after the last sexual exposure to prevent new HIV infection.
For patients with active HBV infection (detectable HBsAg), discontinuation of TDF/FTC PrEP could lead to acute HBV flares or hepatic decompensation, particularly for patients with hepatic cirrhosis; careful monitoring of HBV infection and liver function is recommended after discontinuation of TDF/FTC. For more information see The Safety of Tenofovir–Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B.
19. What are the insurance and payment options for PrEP?
Many insurance plans cover PrEP. TDF-FTC is on the California Medi-Cal formulary and Medi-Cal completely covers the cost of TDF-FTC as PrEP, as well as medical visits and laboratory testing. Prior authorization is NOT required.
Several programs have been established to help cover the cost of PrEP and associated care, including the following three.
Gilead Advancing Access Patient Assistance and Co-pay Coupon Programs
The manufacturer of Truvada (Gilead) has established programs to help cover the cost of PrEP. Advancing Access provides assistance to patients who are uninsured or underinsured, or who need financial assistance to pay for Gilead medications. These programs include:
- Access to counselors who can help patients and their providers with insurance-related questions, including coverage options.
- Patient assistance that provides medications at no charge for eligible patients with no other insurance options. Patients must have annual income less than 500% of the Federal Poverty Level (FPL). In 2019, 500% of FPL is $62,450 for a one-person household.
- Co-pay assistance for eligible patients (up to $7,200 in co-pays per year with no monthly limit).
For more information, call 1-800-226-2056 or visit www.gileadadvancingaccess.com
California PrEP Assistance Program
The State of California also offers the PrEP Assistance Program (CA PrEP-AP) which assists with co-pays, labs, and visits for patients who are underinsured or uninsured and ineligible for Medi-Cal. Providers who prescribe PrEP are eligible to apply to join the CA PrEP-AP Provider network, which allows them to bill the State for labs and visits of eligible patients. For more information about this program or to join the Provider Network, visit https://www.cdph.ca.gov/Programs/CID/DOA/Pages/OA_adap_serviceproviders_prepAP.aspx
Los Angeles County Department of Public Health PrEP Centers of Excellence (PCOE)
In August 2016, DHSP funded nine community agencies and clinics at 14 sites throughout Los Angeles County to serve as “PrEP Centers of Excellence”. The PCOEs offer PrEP at low cost for patients at high risk for HIV acquisition who are uninsured or underinsured. These PCOEs are community clinics with expertise in sexual health, which also offer essential services to address social determinants of health that prevent patients from achieving optimum health, such as benefits navigation, mental health, and substance abuse referrals. Eligibility criteria include:
- Patients must be LA County residents
- Patients must have an income of <500% FPL
For more information, visit http://getprepla.com/centers-excellence.html or call 1-844-YEA-PREP.
20. Is PrEP recommended if the partner is virologically suppressed?
Whether the HIV-negative partner should take PrEP if the positive partner has an undetectable HIV viral load is a matter of substantial debate. This decision must be individualized and may depend on the HIV-positive partner’s virologic control, condom use and other partners that the HIV-negative partner may have. Recent findings from a large cohort study among stable, sero-different couples where the HIV-positive partner was virologically suppressed suggested that in this situation the risk of seroconversion is zero.13 Reasons why PrEP might still be offered include lapses in adherence to antiretroviral therapy and differences between plasma and seminal/vaginal fluid viral load measurements.14 Additionally, research suggests that much of HIV transmission is from non-main partners.15
21. Does a person living with HIV need treatment if their partner is on PrEP?
Yes. The Los Angeles County Public Health Department and national experts recommend that all people with HIV be treated, regardless of clinical status or CD4 cell count.16,17 Virologic suppression of the HIV-infected partner protects his or her health and the health of the HIV uninfected partner.18
22. Can PrEP be used to help sero-different couples conceive?
PrEP may be one of several options to help protect the HIV-negative partner of an HIV positive person during attempts to conceive. Expert consultation is recommended in order to tailor the approach to the specific needs of each couple. It is recommended that in all cases, the HIV-infected partner is given antiretroviral therapy (ART), and that conception is not attempted until virologic suppression is achieved. Extensive counseling of both partners is recommended regardless of the specific approach selected. For more information, consult federal guidelines.19,20
23. Are there new modalities of PrEP in clinical trials?
Yes. Tenofovir alafenamide/emtricitabine (Descovy)
On August 7, 2019, an FDA advisory panel voted in favor of approving tenofovir alafenamide/emtricitabine (TAF/FTC or Descovy™) for daily use PrEP in MSM and transgender women who have sex with men. TAF/FTC is already FDA approved to treat chronic HIV. If the FDA ultimately approves TAF/FTC for PrEP, there will be two daily PrEP options for MSM and transgender women who have sex with men.
Future Possible Routes of Administration
Select long-acting antiretroviral drugs that are administered intramuscularly are being studied for both HIV prevention and HIV treatment. The first large-scale clinical trial of a long-acting injectable for HIV prevention began in December 2016. Called HPTN 083, the NIH-sponsored study—a partnership with ViiV Healthcare and the Bill & Melinda Gates Foundation—is examining whether a long-acting form of the investigational antiretroviral drug cabotegravir, injected once every 8 weeks, can safely protect men and transgender women from HIV infection at least as well as daily PrEP. In 2017, the long-acting injectable cabotegravir for PrEP was found to be well tolerated by study participants. The drug is currently in efficacy trials. Results are expected in 2021. For more information see NIH Launches First Large Trial of a Long-Acting Injectable Drug for HIV Prevention
The National Institutes of Health (NIH) is funding the development and testing of several implants for HIV prevention. These products have not yet entered clinical trials. Studies supported by other funders are exploring an implant for women that protects users from both HIV and unplanned pregnancy.
For more information see Long-Acting HIV Prevention Tools