PrEP Provider Toolkit

Dear Colleague - September 18, 2020

September 18, 2020

Dear Colleague:

HIV is a significant public health threat in South Carolina. Approximately 700 South Carolinians become newly infected with HIV each year. It is estimated that over 20,000 S.C. residents were living with HIV at the end of 2017. Based on the most current data (2018), South Carolina ranks 9th among states for incident cases of HIV. Fortunately, medication is available to help curb the rise in HIV cases, and you can play a key role in increasing the use of highly effective therapies to prevent new HIV infections. 

As a clinician, you are uniquely positioned to help promote HIV pre-exposure prophylaxis (PrEP) as a viable prevention option. HIV PrEP is indicated for HIV-negative individuals at high risk of acquiring HIV. Two medications are available, Truvada® (a fixed-dose combination of emtricitabine/tenofovir disoproxil fumarate) and Descovy ® (a fixed-dose combination of emtricitabine/tenofovir alafenamide). 

In 2014, the Centers for Disease Control and Prevention (CDC) and the U.S. Public Health Service released clinical guidelines recommending that health care providers prescribe HIV PrEP for patients at risk for HIV infection and who meet specified risk criteria. According to CDC, less than a quarter of Americans who could benefit from PrEP use it – and Southerners accounted for only 27% of PrEP users in 2016, even though the region has more than half of new annual HIV cases. 

Increasing the use of PrEP for those at risk is a cornerstone of the national initiative, Ending the HIV Epidemic, launched by the U.S. Department of Health and Human Services. The initiative aims to reduce new HIV infections in the U.S. by 90% by 2030. With more widespread use of PrEP, we can reduce HIV in South Carolina. HIV PrEP can save lives and reduce health care costs associated with HIV/AIDS. The enclosed guidelines provide information needed to prescribe and support PrEP use for eligible patients. 

This year South Carolina will host its first PrEP Awareness Week, September 28th - October 3rd. We encourage you to participate in the daily webinars for providers to learn more about prescribing and managing clients on PrEP. Providers can earn up to 5 FREE continuing education credits during this week. Please visit scdhec.gov/PrEPMeSC for additional information. 

We are also working to build a statewide PrEP provider directory that will be available for consumers and other human services providers to refer persons to clinical PrEP services. If you currently prescribe PrEP and would like to be added to our PrEP directory, please email your practice’s contact information to PrEPMeSC@dhec.sc.gov. Thank you for your consideration of this important public health initiative. 

Please refer to these documents: 

 

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 an 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 clients who are screened as potential candidates
  4. Pre-screening guidance for clinicians to access client readiness
  5. Payment options for clients

The SC DHEC STD/HIV and Viral Hepatitis division of the Bureau of Communicable Diseases and Preventionwill be responsible for maintaining current guidance in The Plan and will serve as a source for technicalassistance and education. The division will utilize CBA (capacity building assistance) to further enhance thecapacity 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 anappointment, referral process, assessing and providing general procedures for STI/HIV testing and diagnostictesting.

The STD/HIV and Viral Hepatitis division will implement PrEP referral services in local health departments toaddress awareness and knowledge surrounding PrEP services. Clients can receive low-cost STI and HIV testingat local health departments. Social workers and disease intervention specialists (DIS) will also provide riskreduction and STI prevention counseling.

II.    Goal of PrEP Therapy 

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.
  • 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 in order to make indicated changes in strategies to support clients’ long-term health.

III.    Medication


Prescription: FDA-approved medications (as of 10/09/2019)

Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; FTC/TDF) 1 tablet PO daily (30-day supply); up to 2 refills. Note: no refills with initiation. Clients should return to clinic 1 month after initiation.
                        OR
Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) 1 tablet PO daily (30-day supply); up to 2 refills. Note: no refills with initiation. Clients should return to clinic 1 month after initiation. Descovy is not approved for cisgender women (women who identify with their assigned gender at birth).

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 pharyngitis3,5

Also, clinicians should consider acute HIV infection 2,3,5:

  1. If the client reports the condom broke during sex with an HIV-positive partner or relapse to injection drug use etc.
  2. 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 after:

  • Rectal - 7 daily doses
  • Cervicovaginal tissue - 20 daily doses
  • Blood- 20 daily doses

Side Effects
“start-up syndrome” - usually resolve within the first month of taking PrEP. Discuss with patient about taking over-the-counter medications for headache, nausea, and flatulence.

  • Headache
  • Weight loss/weight gain
  • Fatigue
  • Gastrointestinal symptoms: nausea, vomiting, flatulence, etc.

Adverse Effects

  • Renal Failure- FTC and TDF are eliminated by the kidneys. Renal impairment, including cases of acute renal failure and Fanconi syndrome associated with TDF2,3.
  • 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/Severe Hepatomegaly with Steatosis
  • Fanconi syndrome

IV.    Clinician Determination of HIV status for PrEP Provision5

Chart for Clinician Determination of HIV status for PrEP Provision 5

 

V.    Laboratory Testing

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 (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.

Serum Creatinine

  • Renal function screening should be assessed. 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 clients with chronic kidney disease

Urinalysis (recommended by manufacture)

  • Urine glucose and urine protein should be assessed prior to initiating PrEP and during use on a clinically appropriate schedule in all individuals 4,5.

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 clients 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 clients 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 assessmentt.
  • Clients 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.

Sexually Transmitted Infections- Syphilis and GC/CT (3-point testing - pharyngeal, genital, and anal)

  • Syphilis- Tests to screen for syphilis are recommended for all adults prescribed PrEP, both at screening and at semi-annual visits.
  • Gonorrhea/Chlamydia- Tests to screen for gonorrhea are recommended for all sexually active adults prescribed PrEP, both at screening and at semi-annual visits. Tests to screen for chlamydia are recommended for all sexually active MSM prescribed PrEP, both at screening prior to initiation and at semi-annual visits. NAAT testing is preferred.

Pregnancy testing, if applicable

VI.    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 South Carolina epidemiological data of high HIV incidence and/or risk factors, should be assessed. This includes: 

  • Men who have sex with men
  • Persons who have inconsistent condom use
  • Persons who inject drugs
  • Persons who have tested positive for bacterial STI in the past 6 months.

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: Quick Guide (CR-012206), which includes basic PrEP information and questions to ask that will gauge readiness or interest in PrEP services.

VII.    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:

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.

VIII.    Clinical Support and Resources

  1. DHEC STD/HIV/VH Division
    Nurse Practitioner, PrEP Program Manager
    803-898-3939
    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
    803-545-5402
    schivtc.med.sc.edu
  4. The Southeast AIDS Education & Training Center Program
    seaetc.com/
     

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

PrEP Provider Reference

 

X.    References:

  1. South Carolina Department of Health and Environmental Control. South Carolina’s STD/HIV/AIDS Data Surveillance Report. https://scdhec.gov/sites/default/files/media/document/STD-HIV-AIDS-Surveillance_Report_2017.pdf. Published December 31, 2017.
  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. South Carolina Department of Health and Environmental Control (2018). An epidemiologic profile of HIV and AIDS in South Carolina 2018. An Epidemiologic Profile of HIV and AIDS in South Carolina 2018
  5. Centers for Disease Control and Prevention: US Public Health Service: Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 Update: a clinical practice guideline. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018.

 

Additional Resources can be found at: 

Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2010–2016. HIV Surveillance Supplemental Report 2019;24 (No. 1). http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published February 2019.