Dear Colleague - September 18, 2023

September 18, 2023

Dear Colleague:

The South Carolina Department of Health and Environmental Control (DHEC) is pleased to announce our 4th annual SC PrEP Awareness Week, Sept. 25- Sept. 29, 2023. This is a statewide campaign to increase HIV pre-exposure prophylaxis (PrEP) awareness, access and uptake in South Carolina.

We invite medical providers, pharmacists, nurses, social workers, health educators and college students to join the daily webinars hosted by the South Carolina HIV/AIDS Clinical Training Center, a partner of the Southeast AIDS Training and Education Center (SE AETC), to learn more about PrEP. Participants can earn up to five FREE continuing medical, nursing, social work or pharmacy education credits.

Amid surging syphilis rates and the mpox outbreak, HIV remains a significant health concern, especially in the Southern states, which account for approximately 50% of new HIV infections. It has been 10 years since the Food and Drug Administration’s (FDA) approval of PrEP; unfortunately, PrEP services remain underutilized in Southern states. Through coordination of multi-faceted efforts and collaborations, this can change. South Carolina and other Southern states have a greater PrEP-to-need ratio. The PrEP-to-need ratio is calculated by comparing newly diagnosed HIV infections with current PrEP prescriptions. Increasing PrEP uptake is a critical HIV prevention intervention.

Our goals include increasing awareness and providers’ knowledge about PrEP and gaining support from many disciplines to increase PrEP uptake statewide. This year's activities and testing events will focus on primary care providers and college health centers across South Carolina. Studies have shown college and university health centers often do not prescribe PrEP or offer PrEP referrals because they are unfamiliar with PrEP. According to the Center for Disease Control and Prevention (CDC), in 2021 people aged 18-22 made up 21% of all new HIV diagnoses. Increased PrEP awareness on college campuses could have a significant impact in protecting young adults from HIV infection and ending the HIV epidemic.

Please visit these links to learn more about PrEP week, PrEP resources and how you can get involved:

• PrEP Awareness Week
• PrEP Awareness Week Brochure (PDF)
• scdhec.gov/PrEP

If you have any questions or concerns, please email us at PrEPMeSC@dhec.sc.gov.

Sincerely,

Linda J. Bell, M.D.
State Epidemiologist
Director, Bureau of Communicable Disease Prevention and Control
Public Health
S.C. Dept. of Health & Environmental Control 

I.    DHEC’s Role

The South Carolina Department of Health and Environmental Control (DHEC) HIV Pre-exposure Prophylaxis (PrEP) Statewide Plan and Guidance (The Plan) has been developed by DHEC as on element of the PrEPMeSC initiative. The Plan provides evidence-based guidance about procedures for increasing PrEP acceptance, PrEP prescribing, PrEP referrals, and diagnostic testing for participating providers.

The Plan will include but not be limited to the following subjects:

1. Mission and purpose of the pre-exposure prophylaxis plan
2. Clinical guidance for prescribing pre-exposure prophylaxis
3. Referral guidance for patients who are screened as potential candidates
4. Pre-screening guidance for clinicians to access client readiness
5. Payment options for patients

The SC DHEC STD/HIV and Viral Hepatitis division of the Bureau of Communicable Diseases and Prevention will be responsible for maintaining current guidance in The Plan and will serve as a source for technical assistance and education. The division will utilize CBA (capacity building assistance) to further enhance the capacity of funded and unfunded entities to effectively implement the pre- exposure prophylaxis plan.

The STD/HIV and Viral Hepatitis division will provide basic procedures for engaging a client, scheduling an appointment, developing a referral process, and providing general procedures for required testing.
The STD/HIV and Viral Hepatitis division will implement PrEP referral services in local health departments to address awareness and knowledge surrounding PrEP services. Patients can receive low-cost STI and HIV testing at local health departments. Social workers and disease intervention specialists (DIS) will also provide risk reduction and STI prevention counseling.

II.   Goal of PrEP Therapy¹

The goal of PrEP is to reduce the acquisition of HIV infection with its resulting morbidity, mortality, and cost to individuals and society. Therefore, clinicians initiating the provision of PrEP should:

• Prescribe medication regimens that are proven safe and effective for uninfected persons who meet recommended criteria to reduce their risk of HIV acquisition.
• Educate clients about the medications and the regimen to maximize their safe use.
• Provide support for medication adherence to help clients achieve and maintain protective levels of medication in their bodies.
• Provide HIV risk-reduction support and prevention services or service referrals to help clients minimize their exposure to HIV and other STIs.
• Provide effective contraception to women who are taking PrEP and who do not wish to become pregnant.
• Monitor clients to detect HIV infection, medication toxicities, and levels of risk behavior to make indicated changes in strategies to support clients’ long-term health.

III.    Referral Process

When screening, clients should be prioritized according to those who are at the highest risk. Clients who are seeking the following services should be assessed for possible PrEP services or referrals: HIV testing, STI screening, family planning, partner services or general inquiry. The priority populations, according to the Centers for Disease Control and Prevention include the following:

• Persons who have a HIV-positive sexual partner (especially if partner has an unknown or detectable viral load).
• Persons who have tested positive for bacterial STI in the past 6 months.
• Persons who have inconsistent condom use with sexual partner(s).
• Persons who inject drugs with HIV-positive injecting partner or sharing injection equipment.

It’s recommended that a designated position either social worker, disease intervention specialist, case manager, linkage coordinator, nurse, clinician, or physician who has, at a minimum, basic knowledge of pre-exposure prophylaxis provide PrEP navigation.
Positions appointed to conduct the screening may also refer to or familiarize themselves with the “PrEPMeSC: Is PrEP right for you?” (CR-012206), which includes basic PrEP information and questions to ask that will gauge readiness or interest in PrEP services.

• Patients who are pre-screened (may include taking a sexual history) and are interested in moving forward should:
  • Be referred to a PrEP coordinator/navigator or someone designated to assess potential PrEP clients for initial assessment.
  • If PrEP services are not offered at your clinic, clients should be provided with a list of providers in their area by accessing them at one of the 4 options:
    • PrEP Locator: https://preplocator.org/
    • SC Providers: https://gis.dhec.sc.gov/HIVLocator/
    • PrEPMeSC PrEP Directory: https://www.scdhec.gov/sites/default/files/Library/CR-012460.pdf

IV.    Clinician Determination of HIV status for PrEP Provision to Persons with Recent or Ongoing Antiretroviral Prophylaxis Use ¹

V.    Laboratory Testing ¹

• HIV Ab/Ag screening (4th generation preferred)
  • HIV-1/HIV-2 testing and documented negative results are required prior to prescribing PrEP medications. For patient safety, HIV testing should be repeated at least every 3 months for oral use and every 2 months for injection use (before prescriptions are refilled or reissued). Note: Rapid tests that use oral fluid should not be used to screen for HIV infection when considering PrEP use because they can be less sensitive than blood tests. Clinicians should not accept patient- reported test results or documented anonymous test results.
• HIV-1 RNA (viral load)
  • HIV-1 RNA assay is recommended within one week of initiation (or collected at initiation) and follow-up due to the long duration of drug exposure with injectable PrEP. This is the most sensitive test to exclude acute HIV in clients receiving the injectable PrEP.
• Serum Creatinine
  • Renal function screening should be assessed for clients receiving oral PrEP (F/TDF or F/TAF). Therefore, all persons considering PrEP should have a serum creatinine test performed, and an eCrCL should be calculated utilizing the Cockcroft-Gault formula. Any person with an eCrCl of <60 ml/min should not be prescribed Truvada or TDF/FTC. If eCrCl <30 ml/min, Descovy is not recommended. Serum phosphorous is recommended in patients with chronic kidney disease.
• Hepatitis B Ab/Ag Screening
  • Vaccination against HBV is recommended for all adolescents and adults at substantial risk for HIV infection, especially for MSM. Therefore, HBV infection status should be documented prior to PrEP being prescribed. Those patients found to be HBsAg positive should be evaluated for possible treatment either by the clinician providing PrEP care or by linkage to an experienced HBV care provider.
  • HBV infection is not a contraindication to PrEP use. Both TDF and FTC are active against HBV. HBV-mono-infected patients taking TDF or FTC, whether as PrEP or to treat HBV infection, who then stop these medications must be closely monitored for severe acute exacerbations of hepatitis B.
• Hepatitis C antibody
  • Serologic testing for HCV is recommended for persons who have ever injected drugs. MSM at substantial risk for HIV infection being started on PrEP have been shown to have a high prevalence of HCV infection. Therefore, MSM starting PrEP should be tested for HCV infection as a part of baseline laboratory assessment.
  • Patients with active HCV infection (HCV RNA+ with or without anti-HCV seropositivity) should be evaluated for possible treatment because TDF/FTC does not treat HCV infection. When the clinician providing PrEP care is not able to provide HCV care, the patient should be linked to an experienced HCV care provider.
• Lipid Panel
  • Higher rates of triglyceride elevation and weight gain was noted among F/TAF users. Persons being prescribed F/TAF should receive annual (every 12 months) triglyceride and cholesterol level monitoring.
• Sexually Transmitted Infections- Syphilis and GC/CT (3-point testing)
  • Syphilis- Tests to screen for syphilis are recommended for all adults prescribed PrEP, both at initiation and follow-up screening visits.
  • Gonorrhea & Chlamydia- Tests to screen for gonorrhea and chlamydia are recommended for all sexually active adults prescribed PrEP, both at initiation and follow-up screening visits. NAAT testing is preferred.
• Pregnancy testing, if applicable
  • T/TDF is approved for PrEP use in pregnant and breastfeeding women.  Data in the Antiretroviral Pregnancy Registry does not have any evidence of adverse effects among fetuses exposed to medication during pregnancy.  Women who become pregnant while taking PrEP should seek prenatal care as soon as possible.

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VI.    Medication

Prescription: FDA-approved medications (as of 9/1/2022)

Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; FTC/TDF (Truvada) 1 tablet PO daily (30-day supply); up to 2 refills. Note: no refills with initiation. Patients should return to clinic 1 month after initiation ^1,2.

Emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF (Descovy) 1 tablet PO daily (30-day supply); up to 2 refills. Note: no refills with initiation. Patients should return to clinic 1 month after initiation. Descovy is not approved for cisgender women (women who identify with their assigned gender at birth) ^1,3.

Cabotegravir 600 mg (Apretude) intramuscular injection (gluteal muscle) every 2 months ^1,4.

*Optional* Cabotegravir 30 mg, 1 tablet PO daily for a 4-week lead-in prior to initial injection. Note: no refills with initiation. Patients should return to clinic 1 month after initiation to receive injection ^1,4.

PrEP should be initiated within one week of a confirmed HIV-negative result. Assess for early side effects, discuss any difficulties with medication adherence and answer any questions at 1-month follow-up. Also assess for signs and symptoms of acute HIV infection, which include fever, fatigue, myalgia, skin rash, cervical adenopathy, night sweats, headache, and/or pharyngitis ^3,5.

Also, clinicians should consider acute HIV infection ^_1,2,3,4:

1. I.    If the client reports the condom broke during sex with an HIV-positive partner or relapse to injection drug use etc.
2. II.    If the client describes any nonspecific signs and symptoms of a viral infection during the past month or on the day of visit.

Protection - maximum intracellular concentrations of TFV-DP (activated form of medication) achieved in the following durations ¹:

• Blood (peripheral blood mononuclear cells) - 7 daily days
• Cervicovaginal Tissue - 20 daily days
• Rectal Tissue- 7 daily days

Data is not currently available for to estimate the maximum protection against HIV infection in F/TDF or F/TAF in penile tissue or injectable PrEP ¹.

VII.    Side Effects

Common Side Effects

• “Start-up syndrome” - usually resolve within the first month of taking PrEP. Discuss with client about the use of over-the-counter medication to assist with temporary side effects ¹.
  • Headache
  • Nausea
  • Abdominal discomfort
• Weigh loss reported with F/TDF use ².
• Weight gain was reported with F/TAF use ¹.
• Injection site reactions - Inform clients these reactions are common and transient. Clients can take over-the-counter medication prior to (1-2 hours) or after receiving injection or a apply a warm compress or heating pad to injection site for 15-20 minutes after injection ¹.
  • Pain
  • Tenderness
  • Induration

Adverse Effects

Oral Medications ^2,3

• Renal Failure - FTC and TDF are eliminated by the kidneys. Renal impairment, including cases of acute renal failure and Fanconi syndrome associated with TDF ^2,3.
• Decrease bone mineral density (BMD)- only observed in 3-4% of HIV-infected individuals taking medications with TDF. In clinical trials TDF was associated with slightly greater decreases in BMD and increases in biochemical markers of bone metabolism. Also, parathyroid hormone and 1,25 Vitamin D levels were also higher with TDF users. Unclear if it would be seen in HIV-uninfected individuals taking fewer antiretroviral meds ^2,3.
• Severe Acute Exacerbations of Hepatitis B in patients with HBV.
• Lactic Acidosis and Severe Hepatomegaly.
• Serum Lipid changes reported with F/TAF ³.

Injection Medication

• Hepatotoxicity was reported in a limited number of individuals ⁴.
• Depressive Disorder (including depression, depressed mood, major depression, persistent depressive disorder, suicide ideation or attempt)

Additional Counseling

• Clients discontinuing the injection, should be informed about the long “tail” of gradually declining drug levels and the risk for developing a drug-resistant strain if HIV infection is acquired during that time ⁴.  

VIII.    Data Collection

SC DHEC is working to improve data collection regarding PrEP uptake in the state. For those who are funded by SC DHEC, you should use the following modalities to input data regarding PrEP:

• EvaluationWeb- Prevention grantees
• PrEP QA Monitoring Tool

Non-DHEC funded agencies (providers) can utilize the PrEP QA Monitoring tool to report PrEP data. Please submit report by the 15th of each month to preventionreports@dhec.sc.gov.

IX.    Clinical Support and Resources

1. DHEC STD/HIV/VH Division, Nurse Practitioner, PrEP Program Manager, 803-898-3939 Email address: prepmesc@dhec.sc.gov
2. Clinician Consultation Center PrEPLine 1-855-448-7737. Clinicians are available Monday through Friday, 9 a.m.- 8 p.m. EST
3. University of South Carolina Telehealth, http://schivtc.med.sc.edu/, 803-545-5402
4. The Southeast AIDS Education& training Center Program, https://www.seaetc.com/

X.    Quick Provider Reference for Oral HIV Pre-exposure Prophylaxis (PrEP):

XI.    Quick Provider Reference for Injectable HIV Pre-exposure Prophylaxis (PrEP)

XII.    References

1. Centers for Disease Control and Prevention: US Public Health Service: Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 Update: a clinical practice guideline. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Published 2021.
2. Truvada (emtricitabine and tenofovir disoproxil fumarate) [package insert] Foster City, CA: Gilead Sciences, Inc.; 2018. https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf
3. Descovy (emtricitabine and tenofovir alafenamide tablets) [package insert] Foster City, CA: Gilead Sciences, Inc.; revised 2019. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf
4. Apretude (cabotegravir extended-release injectable suspension) [package insert] Research Triangle Park, NC: Viiv Healthcare; 2021. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF

Additional Resources can be found at:

1. Centers for Disease Control and Prevention. HIV Surveillance Report, 2020; vol. 33. https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May 2022. Accessed [September 21, 2022].
2. South Carolina Department of Health and Environmental Control. South Carolina epidemiologic profile of HIV, AIDS, and sexually transmitted infections 2020. South Carolina Epidemiologic Profile of HIV, AIDS, and Sexually Transmitted Infections 2020. Accessed [September 21, 2022].