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. HIV Medications risk adverse effects
    1. Risk of Renal Failure, liver toxicity, Osteoporosis
    2. Review Drug Interactions and adverse effects with patient prior to starting PrEP
  3. Financial costs were previously high for Truvada in addition to periodic labs and clinic visits
    1. However, now generic Truvada costs $80/month
      1. Prior to generics, was very expensive ($1300 per month and $14,000 per year)
    2. In U.S. under Affordable Care Act as of 2022, PrEP can be obtained without copay
      1. If no insurance, there is a "Ready, Set, PrEP" program

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. High risk of HIV Exposure (or per patient request)
    1. HIV positive partner (or partner at high risk with unknown status)
      1. HIV positive with undetectable viral load is low risk of transmission
      2. Rodger (2016) JAMA 316(2): 171-81 +PMID: 27404185 [PubMed]
    2. Sexually active with partner who shares needles
    3. Sexually active in high HIV Prevalence region or social network
    4. Inadequate Condom adherence
    5. Sexually Transmitted Infection within the last 3-6 months
    6. Illicit Drug use or Alcohol Dependence (including sex under the influence)
    7. Sex worker or barters for sex
    8. Gonorrhea or Syphilis in last 6 months

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
      1. Risk of resistance if HIV positive patients remain only on HIV PrEP
      2. Switch to HIV Treatment if HIV positive
  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)
    1. Risk of Hepatitis BVirus fare on starting Truvada
  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. Immunizations
    1. Hepatitis B Vaccine
  3. Antiretroviral therapy
    1. Requires strict Medication Compliance (medication must be taken everyday, not simply before intercourse)
    2. Repeat test for Sexually Transmitted Infection every 3 months
    3. First-line options
      1. Emtricitabine 200 mg and Tenofovir Disoproxil fumarate 300 mg (Truvada) orally daily
        1. Generic Truvada costs $80/month in 2022
        2. Monitor Renal Function and avoid with NSAIDs
        3. Consider monitoring Bone Mineral Density
    4. Alternative options
      1. Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (Descovy) orally daily
        1. Appears effective for HIV PrEP in men and transgender Men who have Sex with Men
        2. May be preferred in reduced Renal Function (GFR >30 ml/min) or Osteoporosis
        3. Costs $2000 per month in 2022
        4. FDA Approved for HIV PrEP in October 2019
          1. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic
      2. Cabotegravir (Apretude) Injectable
        1. Indicated in Creatinine Clearance <30 ml/min or non-compliance
        2. Gluteal Intramuscular Injection (gluteal) monthly for 2 months and then every 2 months
        3. Administered in clinic at cos of $3700/dose

VIII. Efficacy: Truvada

  1. May reduce HIV risk by 92-96% if Truvada is taken daily
  2. Number Needed to Treat: 44-60 to prevent HIV in one man/year who has multiple male sexual partners
  3. Truvada does not reach maximal protective effect for 3 weeks after starting

IX. Adverse Effects

  1. Antiretroviral therapy adverse effects
    1. See Truvada (Emtricitabine with Tenofovir) or Descovy for adverse effects and Drug Interactions
    2. Start-up syndrome (Nausea, Abdominal Pain, Flatulence, Headache) which typically resolves after the first month
    3. Monitor Renal Function and Bone Mineral Density
  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

  1. (2022) Presc Lett 29(2): 10
  2. (2018) Presc Lett 25(5): 26
  3. (2014) Presc Lett 21(7): 41
  4. (2012) Presc Lett 19(8): 44
  5. Baeten (2012) N Engl J Med 367:399-410 [PubMed]
  6. Grant (2010) N Engl J Med 363(27):2587-99 +PMID:21091279 [PubMed]
  7. Sherin (2014) Am Fam Physician 89(4): 265-72 [PubMed]

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