For PrEP Prescribers

Step-by-Step Guidance

To download this information in checklist form:

The UNC ID Clinic working group on PrEP uses a Patient/Provider contract for PrEP, which sets some “ground rules” at baseline. Modeled on a contract for patients receiving narcotics, this document spells out expectations of the patient and provider surrounding PrEP management. A signed copy is given to the patient.

Step by Step Provider Checklist

If your patient has one or more of the risk factors below, s/he could benefit from PrEP as part of an overall HIV risk-reduction plan.

Risks for sexual transmission

□ Condomless sex in prior 6 mos.

□ Any STI diagnosed in prior 6 mos.

□ Sex with partners of unknown HIV status

□ Monogamous relationship with HIV+ partner(s)

□ Commercial sex work

□ High-prevalence area / sexual network

Risks for parenteral transmission

□ Shared injection equipment (needles or “works”)

□ Known HIV+ injecting partner(s)

□ Recent drug treatment
(but currently still injecting)

□ Sexually active with injecting partner(s)

NOTE: In North Carolina, the sexual networks of young, Black men who have sex with men have a very high HIV prevalence of at least 30%. If you’d like to examine the prevalence of HIV in your county or city, check out AIDSvu (a service of Emory University and the CDC).

Before starting PrEP, you must confirm that your patient is negative for hepatitis B and HIV, and that her/his renal function is normal at baseline. Links to ordering menus from LabCorp and Quest Diagnostics can be found below.

Within 30 days BEFORE starting PrEP:

□ Hepatitis B surface antigen (sAg)

□ Hepatitis B surface antibody (sAb)

Must be HBsAg negative

  • Truvada treats HBV, and stopping it abruptly can cause a “flare” with illness
□ Serum creatinine

□ Estimated creatinine clearance

□ Urinalysis

eCrCl must be ≥ 60 mL/min
(preferably by Cockcroft-Gault)Urinalysis establishes a baseline

  • This will help evaluate abnormalities in unlikely event they occur later on

Within 7 days BEFORE starting PrEP:

Test for HIV with ONE of the following

□ HIV RNA (viral load)

□ Antigen/antibody combination assay (“4th generation”)

□ Rapid test with fingerstick blood

□ “Traditional” blood test with ELISA (EIA) and reflexive confirmatory testing

Must be HIV negative

  • Preference for HIV RNA (viral load) or 4th generation Ag/Ab assay; both can detect early HIV infection
  • Do NOT rely on oral rapid testing; sensitivity lower than with blood
Any of these symptoms in prior month?

□ Fever

□ Fatigue

□ Skin rash

□ Pharyngitis

□ Cervical adenopathy

No symptoms of acute HIV infection

  • Must be free of these symptoms in the month prior to starting PrEP
  • If ANY symptoms are present, rule out acute HIV infection by ordering HIV RNA (viral load)

Quest Diagnostics

Hepatitis B surface antibody – test number 8475

Hepatitis B surface antigen – test number 498

HIV 4th generation antigen/antibody combination assay – test number 91431

HIV RNA viral load – test number 40085

LabCorp

Click here for test menu search and enter the test numbers below

Hepatitis B surface antibody – test number 006530

Hepatitis B surface antigen – test number 006510

HIV 4th generation antigen/antibody combination assay – test number 083935

HIV RNA viral load – test number 550430

PrEP is part of helping patients maintain their sexual health, so you should consider testing for other sexually transmitted infections (STIs), if not already done in the prior 3-6 months. Screening should include:

Serum RPR for syphilis

Nucleic acid amplification tests (NAATs) for gonorrhea and chlamydia – with samples from cervix, urine, or urethra along with extragenital sites (pharynx, rectum) as appropriate

Nucleic acid amplification test for Trichomonas vaginalis (or wet prep) for sexually active women and heterosexual men

□ Strongly consider hepatitis C antibody for anyone who injects drugs, has had sex with an injection drug user, and men who have sex with men

NOTE: Independent labs like LabCorp and Quest Diagnostics have validated the use of NAATs from pharyngeal and rectal specimens. Whatever test kit you use in your office to collect cervical or urethral samples can probably also be used to collect extragenital samples. If you have a question, you should contact your lab vendor to make sure. They may be able to provide dedicated kits, if needed.

Counseling about medication side effects, adherence strategies, and symptoms of sexually transmitted infections is important prior to starting PrEP.

Side effects

Generally Truvada is well-tolerated and side effects are minimal. Key points:

  • Some patients develop mild headaches, nausea or flatulence after starting PrEP.
  • For most, these symptoms go away within the first month (a so-called “startup syndrome”).
  • If your patient develops any unexpected reaction – especially a skin rash – s/he should contact your office and request a follow-up evaluation.

Adherence and dosing strategies

Encourage your patient to:

  • Pair pill-taking with a daily task – something they do consistently every day, including on weekends. Examples include eating breakfast, brushing teeth, or plugging in a cell phone before bedtime.
  • Set an alarm on a clock, wristwatch, or cell phone
  • Use a pill box to help verify they’ve taken the day’s dose, thus avoiding missed or doubled doses
  • Keep an extra dose handy at work or in the car to help avoid missing a dose

Provide some anticipatory guidance:

  • A dose can safely be taken 3-4 hours before or after a planned dosing time. It’s better to take a dose a bit early or a bit late rather than miss a dose entirely! Outside that window, it’s probably best to skip the dose and begin the following day on the pre-planned schedule.
  • There are no interactions with Truvada and alcohol or recreational drugs – but you should encourage patients to avoid using substances around the time of sexual activity. Some patients skip medications if they know they’re going to be going out to a bar or club out of concern for interactions with alcohol.

Signs and symptoms of sexually transmitted infections

Encourage your patient to contact you promptly if s/he develops:

  • pain or burning with urination (urethritis from multiple possible causes)
  • sore throat with or without lymphadenopathy following a sexual encounter (differential includes gonococcal pharyngitis and acute HIV infection)
  • urethral, rectal, or vaginal discharge (typically from gonorrhea or chlamydia)
  • skin rashes, especially involving the palms and soles (possible herpes, HPV, or syphilis)

The CDC’s STD website also has information for patients about these infections, testing, and treatment.

Prescription should read:
Truvada (emtricitabine/tenofovir) 200/300mg
One tablet PO daily

First prescription should be for 30 tablets (one month). This allows a short-interval follow-up to assess adherence and side effects.

Subsequent prescriptions be for 30 tablets with 2 refills. This allows for the patient to return for their required HIV testing every 3 months while on PrEP.

Helping Your Patient Pay for PrEP

Patient assistance is available from Gilead Science, the manufacturer of Truvada. This program is available to insured patients as a copayment assistance program, and to uninsured patients as a medication access program. For additional details, visit Gilead’s dedicated webpage for PrEP patient assistance: http://start.truvada.com/individual/truvadaprep-copay.

You or your patient can begin the application process by:

The most important component of follow-up is frequent testing for HIV – at least every 3 months, for ALL patients on PrEP.

The recommended schedule of assessments below is the minimum follow-up. Providers should feel free to schedule interim visits or assessments more frequently, depending on the patient’s individual circumstances.

At least every 3 months:

HIV testing with strong preference given to a 4th generation antigen/antibody combination assay (see ordering info for LabCorp and Quest above, under Step 2)

□ Assess adherence

□ Assess side effects

□ Assess risk-reduction behaviors

□ Pregnancy testing, as appropriate

□ Provide a refill prescription

ADDITIONALLY, at least every 6 months:

□ Serum creatinine with estimated creatinine clearance calculation

□ STI testing, if not already done (see Step 3 above)

ADDITIONALLY, at least every 12 months:

□ Urinalysis with dipstick

If after reviewing the information here you still have a specific question about a patient on PrEP, scroll to the bottom of this page for contacts who can help.

Clinician Contacts for Help with PrEP

  • Call PrEPline, a service of the Clinician Consultation Center at the University of California, San Francisco, at 1-855-448-7737 (11 AM and 6 PM EST)
  • Contact a UNC Infectious Diseases clinical fellow or attending physician through the Carolina Consultation Center, at 1-800-862-6264. Between 8 AM and 5 PM on weekdays, you’ll speak with an attending physician. After hours and on weekends, you’ll speak with a fellow (who can reach an attending physician quickly, if needed).
  • Email a UNC Infectious Diseases provider who has agreed to provide clinical guidance on issues related to PrEP. Please allow up to 48 hours for a response.
Click Here for Dr. Wohl’s presentation Moving beyond condoms to prevent HIV transmission.
Click Here for Dr. Hurt’s webinar presentation on prescribing PrEP.

Are You Providing PrEP?

If you would like to have your practice added to our map of PrEP providers in North Carolina, please email Christopher Hurt, MD with UNC Infectious Diseases at .