HIV Preexposure Prophylaxis

Aka: HIV Preexposure Prophylaxis, HIV Pre-exposure Prophylaxis, HIV PrEP

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II. Definitions

  1. HIV Preexposure Prophylaxis
    1. High risk adult HIV prevention protocol prior to exposure

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
    9. Pregnancy in patients with risk factors as above

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 (HIV Ag/Ab and HIV RNA assay) 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. Weight <35 kg (HIV PrEP is approved for teens, weight >35kg)
  4. Lactation
  5. Pregnancy
    1. Relative contraindication - may be continued with Informed Consent
    2. Emtricitabine with Tenofovir disoproxil Fumarate (Truvada, FTC/TDF) is considered safe and preferred in pregnancy
  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. Follow-up visits every 3 months (2 months if on Cabotegravir )
    3. Repeat test for Sexually Transmitted Infection every 3 months
    4. Protocols are approved for adults and teens with weight >35 kg
    5. First-line options
      1. Emtricitabine 200 mg and Tenofovir disoproxil Fumarate 300 mg (Truvada, FTC/TDF) orally daily
        1. Generic Truvada costs $80/month in 2022
        2. Monitor Renal Function (avoid if eGFR <60 ml/min) every 6 months, and avoid with NSAIDs
        3. Repeat HIV Test (HIV Ag/Ab and HIV RNA assay) and other STI every 3 months
        4. Preferred in pregnancy and Lactation, and also preferred in IVDA
        5. Consider monitoring Bone Mineral Density
    6. Alternative options
      1. Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (Descovy, FTC/TAF) 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. Repeat HIV Test (HIV Ag/Ab and HIV RNA assay) and other STI every 3 months
        4. Monitor for weight gain
        5. Hypertriglyceridemia risk (monitor lipid panel at least yearly)
        6. Not FDA approved for HIV PrEP in receptive vaginal intercourse
        7. Costs $2200 per month in 2024
        8. 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. May be used in Creatinine Clearance <30 ml/min
        4. Administered in clinic at cos of $3900/dose in 2024
        5. Repeat HIV Test (HIV Ag/Ab and HIV RNA assay) and other STI with every dose

VIII. Efficacy: Truvada

  1. May reduce HIV risk by 92-96% (up to 99%) 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 and sterile needles to further prevent HIV, Viral Hepatitis and other infections and STDs

XI. Resources

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

XII. References

  1. (2024) Presc Lett 31(4): 23
  2. (2022) Presc Lett 29(2): 10
  3. (2018) Presc Lett 25(5): 26
  4. (2014) Presc Lett 21(7): 41
  5. (2012) Presc Lett 19(8): 44
  6. Baeten (2012) N Engl J Med 367:399-410 [PubMed]
  7. Grant (2010) N Engl J Med 363(27):2587-99 +PMID:21091279 [PubMed]
  8. Sherin (2014) Am Fam Physician 89(4): 265-72 [PubMed]
  9. Tracer (2023) Am Fam Physician 108(6): 617-8 [PubMed]

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