II. Definition
- High risk adult HIV prevention protocol
III. Precautions
- High risk of noncompliance and secondary Antiretroviral resistance
- Compliance is critical (must take daily to prevent HIV resistance)
- Does not replace safe sex practices (Condoms)
-
HIV Medications risk adverse effects
- Risk of Renal Failure, liver toxicity, Osteoporosis
- Review Drug Interactions and adverse effects with patient prior to starting PrEP
- Financial costs were previously high for Truvada in addition to periodic labs and clinic visits
- However, now generic Truvada costs $80/month
- Prior to generics, was very expensive ($1300 per month and $14,000 per year)
- In U.S. under Affordable Care Act as of 2022, PrEP can be obtained without copay
- If no insurance, there is a "Ready, Set, PrEP" program
- However, now generic Truvada costs $80/month
IV. Indications
- HIV negative adult (over age 18 years) AND
- Understands and consents to risks and benefits of therapy AND
- Able to comply with strict daily medication adherance and follow-up with HIV Test every 3 months AND
- High risk of HIV Exposure (or per patient request)
- HIV positive partner (or partner at high risk with unknown status)
- HIV positive with undetectable viral load is low risk of transmission
- Rodger (2016) JAMA 316(2): 171-81 +PMID: 27404185 [PubMed]
- Sexually active with partner who shares needles
- Sexually active in high HIV Prevalence region or social network
- Inadequate Condom adherence
- Sexually Transmitted Infection within the last 3-6 months
- Illicit Drug use or Alcohol Dependence (including sex under the influence)
- Sex worker or barters for sex
- Gonorrhea or Syphilis in last 6 months
- HIV positive partner (or partner at high risk with unknown status)
V. Labs
-
HIV Screening
- PrEP requires negative results of current HIV Screening protocol (fourth generation testing as of 2014)
- Repeat HIV Test every 3 months
- Risk of resistance if HIV positive patients remain only on HIV PrEP
- Switch to HIV Treatment if HIV positive
-
Sexually Transmitted Infection screening
- Increased risk of HIV Transmission with comorbid Sexually Transmitted Infection
- Repeat every 6 months
-
Hepatitis B Virus Testing (xHBsAg)
- Risk of Hepatitis BVirus fare on starting Truvada
-
Serum Creatinine
- Onset (avoid starting if Creatinine Clearance <60 ml/min)
- Repeat 3 months after starting
- Repeat every year
VI. Contraindications
- HIV positive status (or unknown status)
- Non-compliance or unable to comply with monitoring
- Age under 18 years of age
- Lactation
- Pregnancy
- Relative contraindication - may be continued with Informed Consent
-
Creatinine Clearance <60 ml/min
- Relative contradindication
VII. Management
- Ongoing HIV preventive counseling
- Behavioral risk reduction
- Condom easy access
- Pregnancy status monitoring
- STD Screening and management
- Immunizations
-
Antiretroviral therapy
- Requires strict Medication Compliance (medication must be taken everyday, not simply before intercourse)
- Repeat test for Sexually Transmitted Infection every 3 months
- First-line options
- Emtricitabine 200 mg and Tenofovir Disoproxil fumarate 300 mg (Truvada) orally daily
- Generic Truvada costs $80/month in 2022
- Monitor Renal Function and avoid with NSAIDs
- Consider monitoring Bone Mineral Density
- Emtricitabine 200 mg and Tenofovir Disoproxil fumarate 300 mg (Truvada) orally daily
- Alternative options
- Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (Descovy) orally daily
- Appears effective for HIV PrEP in men and transgender Men who have Sex with Men
- May be preferred in reduced Renal Function (GFR >30 ml/min) or Osteoporosis
- Costs $2000 per month in 2022
- FDA Approved for HIV PrEP in October 2019
- Cabotegravir (Apretude) Injectable
- Indicated in Creatinine Clearance <30 ml/min or non-compliance
- Gluteal Intramuscular Injection (gluteal) monthly for 2 months and then every 2 months
- Administered in clinic at cos of $3700/dose
- Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (Descovy) orally daily
VIII. Efficacy: Truvada
- May reduce HIV risk by 92-96% if Truvada is taken daily
- Number Needed to Treat: 44-60 to prevent HIV in one man/year who has multiple male sexual partners
- Truvada does not reach maximal protective effect for 3 weeks after starting
IX. Adverse Effects
-
Antiretroviral therapy adverse effects
- See Truvada (Emtricitabine with Tenofovir) or Descovy for adverse effects and Drug Interactions
- Start-up syndrome (Nausea, Abdominal Pain, Flatulence, Headache) which typically resolves after the first month
- Monitor Renal Function and Bone Mineral Density
-
Hepatitis B
Virus flare
- Associated with abrupt cessation of Antiretroviral therapy
- Acute Renal Failure
X. Prevention
- See HIV Transmission Prevention
- Use Condoms to further prevent HIV and other STDs
XI. Resources
- CDC HIV Pre-exposure Prophylaxis Information
XII. References
- (2022) Presc Lett 29(2): 10
- (2018) Presc Lett 25(5): 26
- (2014) Presc Lett 21(7): 41
- (2012) Presc Lett 19(8): 44
- Baeten (2012) N Engl J Med 367:399-410 [PubMed]
- Grant (2010) N Engl J Med 363(27):2587-99 +PMID:21091279 [PubMed]
- Sherin (2014) Am Fam Physician 89(4): 265-72 [PubMed]