Madison Clinic
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Pre-Exposure Prophylaxis [PrEP]

The CDC has issued interim guidance [1] on using tenofovir-emtricitabine for the prevention of HIV acquisition in HIV-negative men who have sex with men in the aftermath of the Pre-Exposure Prophylaxis Initiative (iPrEX) study, published Dec 2010 in the NEJM [2].

As a Ryan White funded clinic, we do not provide care for HIV-uninfected individuals (aside from cases of post-exposure prophylaxis) and therefore not likely to be providing PrEP. The link below is a reference for those situations when we may be asked by patients, partners and other providers about this new intervention.

Key ELEMENTS OF THE INTERIM GUIDELINES are as follows:
1. PrEP is for men who have sex with men at high-risk for HIV acquisition -- we do not know about the efficacy/effectiveness in other groups;

2. PrEP must be delivered in the context of a comprehensive set of prevention services that includes risk reduction counseling, condoms and diagnosis/treatment of STIs;

3. Screening patients for chronic hepatitis b before PrEP is necessary given the activity of Truvada against HBV and the consequences of treatment and treatment interruption.

4. PrEP will require baseline & frequent monitoring of HIV status and renal function, as well as frequent assessment of side effects and adherence.

MMRW Table: CDC interim guidance for health-care providers electing to provide preexposure prophylaxis (PrEP) for the prevention of HIV infection in adult men who have sex with men and who are at high risk for sexual acquisition of HIV

 

Before initiating PrEP

Determine eligibility

  • Document negative HIV antibody test(s) immediately before starting PrEP medication.
  • Test for acute HIV infection if patient has symptoms consistent with acute HIV infection.
  • Confirm that patient is at substantial, ongoing, high risk for acquiring HIV infection.
  • Confirm that calculated creatinine clearance is ≥60 mL per minute (via Cockcroft-Gault formula).

Other recommended actions

  • Screen for hepatitis B infection; vaccinate against hepatitis B if susceptible, or treat if active infection exists, regardless of decision about prescribing PrEP.
  • Screen and treat as needed for STIs.

Beginning PrEP medication regimen

  • Prescribe 1 tablet of Truvada* (TDF [300 mg] plus FTC [200 mg]) daily.
  • In general, prescribe no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV-uninfected.
  • If active hepatitis B infection is diagnosed, consider using TDF/FTC for both treatment of active hepatitis B infection and HIV prevention.
  • Provide risk-reduction and PrEP medication adherence counseling and condoms.

Follow-up while PrEP medication is being taken

  • Every 2--3 months, perform an HIV antibody test; document negative result.
  • Evaluate and support PrEP medication adherence at each follow-up visit, more often if inconsistent adherence is identified.
  • Every 2--3 months, assess risk behaviors and provide risk-reduction counseling and condoms. Assess STI symptoms and, if present, test and treat for STI as needed.

  • Every 6 months, test for STI even if patient is asymptomatic, and treat as needed.
  • 3 months after initiation, then yearly while on PrEP medication, check blood urea nitrogen and serum creatinine.

n discontinuing PrEP (at patient request, for safety concerns, or if HIV infection is acquired)

  • Perform HIV test(s) to confirm whether HIV infection has occurred.
  • If HIV positive, order and document results of resistance testing and establish linkage to HIV care.
  • If HIV negative, establish linkage to risk-reduction support services as indicated.
  • If active hepatitis B is diagnosed at initiation of PrEP, consider appropriate medication for continued treatment of hepatitis B.



REFERENCES
1. CDC Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men. MMWR Jan 28, 2011;60(3):65-68.

2. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363:2587–99.

 

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