II. Definition

  1. High risk adult HIV prevention protocol

III. Precautions

  1. High risk of noncompliance and secondary Antiretroviral resistance
    1. Compliance is critical (must take daily to prevent HIV resistance)
    2. Does not replace safe sex practices (Condoms)
  2. Financial costs are very high for Truvada in addition to periodic labs and clinic visits
    1. Very expensive ($1300 per month and $14,000 per year)
  3. Risk of Renal Failure, liver toxicity, Osteoporosis

IV. Indications

  1. HIV negative adult (over age 18 years) AND
  2. Understands and consents to risks and benefits of therapy AND
  3. Able to comply with strict daily medication adherance and follow-up with HIV Test every 3 months AND
  4. Very high risk of HIV Exposure
    1. HIV positive partner (or partner at high risk with unknown status)
    2. Sexually active in high HIV Prevalence region or social network
    3. Inadequate Condom adherence
    4. Has Sexually Transmitted Disease
    5. Illicit Drug use or Alcohol Dependence
    6. Sex worker or barters for sex

V. Labs

  1. HIV Screening
    1. PrEP requires negative results of current HIV Screening protocol (fourth generation testing as of 2014)
    2. Repeat HIV Test every 3 months
  2. Sexually Transmitted Infection screening
    1. Increased risk of HIV Transmission with comorbid Sexually Transmitted Infection
    2. Repeat every 6 months
  3. Hepatitis B Virus testing (xHBsAg)
  4. Serum Creatinine
    1. Onset (avoid starting if Creatinine Clearance <60 ml/min)
    2. Repeat 3 months after starting
    3. Repeat every year

VI. Contraindications

  1. HIV positive status (or unknown status)
  2. Non-compliance or unable to comply with monitoring
  3. Age under 18 years of age
  4. Lactation
  5. Pregnancy
    1. Relative contraindication - may be continued with Informed Consent
  6. Creatinine Clearance <60 ml/min
    1. Relative contradindication

VII. Management

  1. Ongoing HIV preventive counseling
    1. Behavioral risk reduction
    2. Condom easy access
    3. Pregnancy status monitoring
    4. STD Screening and management
  2. Antiretroviral therapy
    1. Requires strict Medication Compliance (medication must be taken everyday, not simply before intercourse)
    2. Patient should be aware that Truvada costs $1300/month (as of 2014)
    3. Emtricitabine 200 mg and Tenofovir 300 mg (Truvada) orally daily
  3. Immunizations
    1. Hepatitis B Vaccine

VIII. Efficacy

  1. May reduce HIV risk by 92% if Truvada is taken daily
  2. Prevents one case of HIV in 44 Men who have Sex with Men each year

IX. Adverse Effects

  1. Antiretroviral therapy adverse effects
    1. See Truvada (Emtricitabine with Tenofovir)
    2. Start-up syndrome (Nausea, Abdominal Pain, Flatulence, Headache) which typically resolves after the first month
  2. Hepatitis B Virus flare
    1. Associated with abrupt cessation of Antiretroviral therapy
  3. Acute Renal Failure
    1. Risk when Truvada is combined with multiple dose or high dose NSAIDs

X. Prevention

  1. See HIV Transmission Prevention
  2. Use Condoms to further prevent HIV and other STDs

XI. Resources

  1. CDC HIV Pre-exposure Prophylaxis Information
    1. http://www.cdc.gov/hiv/prevention/research/prep/

XII. References

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