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HIV PROPHYLAXIS










  • Numbers are based on CDC data from 2018 (37,968 cases) and 2019 (34,800 cases)
Annual new cases of HIV in the U.S.
Group % of new cases
Sex
Men (overall) 81%
Men (gay and bisexual) 70%
Women 18%
Age
Age 13 - 24 years 21%
Age 25 - 34 years 40%
Age 35 - 44 years 20%
Race
Black 41%
Hispanic 29%
White 25%
High-risk behavior
People who inject drugs 10%

  • Reference [2]
Estimated risk of acquiring HIV by exposure type
Exposure type Rate of HIV acquisition
per 10,000 exposures
Parenteral
Blood transfusion 9,250
Needle sharing during injection drug use 63
Percutaneous (needlestick) 23
Sexual
Receptive anal intercourse 138
Receptive penile-vaginal intercourse 8
Insertive anal intercourse 11
Insertive penile-vaginal intercourse 4
Receptive oral intercourse low
Insertive oral intercourse low
Other
Biting Negligible
Spitting Negligible
Throwing body fluids (including semen or saliva) Negligible
Sharing sex toys Negligible



  • Reference [1]
ORAL PREP CRITERIA (CDC 2021)
Sexually-active adults and adolescents weighing at least 77 lbs (35 kg)
Sexual history - anal or vaginal sex in past 6 months and any of the following:
  • HIV-positive sexual partner (especially if partner has an unknown or detectable viral load)
  • Bacterial STI in past 6 months defined as:
    • Gonorrhea, chlamydia, and syphilis for MSM and transgender women who have sex with men including those who inject drugs
    • Gonorrhea and syphilis for heterosexual women and men including persons who inject drugs
  • History of inconsistent or no condom use with sexual partner(s)

Clinical eligibility - must meet all the following:
People who inject drugs that share injection equipment and/or have HIV-positive injecting partners
Must meet all the following:

  • Reference [1]
INJECTABLE PREP CRITERIA (CDC 2021)
Sexually-active adults
Sexual history - anal or vaginal sex in past 6 months and any of the following:
  • HIV-positive sexual partner (especially if partner has an unknown or detectable viral load)
  • Bacterial STI in past 6 months defined as:
    • Gonorrhea, chlamydia, and syphilis for MSM and transgender women who have sex with men including those who inject drugs
    • Gonorrhea and syphilis for heterosexual women and men including persons who inject drugs
  • History of inconsistent or no condom use with sexual partner(s)

Clinical eligibility - must meet all the following:
People who inject drugs that share injection equipment and/or have HIV-positive injecting partners
Must meet all the following:

  • Reference [2]
NPEP RECOMMENDATIONS (CDC 2016)
NPEP is recommended if all of the following are met:
  • ≤ 72 hours since exposure
  • Source patient is known to be HIV-positive
  • Exposure type:
    • Exposed surface: vagina, rectum, eye, mouth, other mucous membrane, nonintact skin, or percutaneous contact
    • HIV-positive source: blood, semen, vaginal secretions, rectal secretions, breast milk, or any body fluid that is visibly contaminated with blood

  • If HIV status of source patient is unknown, NPEP should be considered on a case-by-case basis

NPEP is not recommended (regardless of source HIV status) if any of the following are true:
  • ≥ 73 hours since exposure
  • Exposure type:
    • Exposed surface: vagina, rectum, eye, mouth, other mucous membrane, intact or nonintact skin, or percutaneous contact
    • Exposure source: urine, nasal secretions, saliva, sweat, or tears it not visibly contaminated with blood



hiv infection markers in blood
  • NP = not performed
  • If HIV-2 or HIV differentiation is repeatedly indeterminate, further testing for HIV-2 should be performed
  • Reference [3]
HIV screening test interpretation
HIV 1/2 antigen
antibody test
HIV 1/2 antibody
differentiation
HIV-1 NAT Interpretation
Negative NP NP Negative
Positive HIV-1 (+)
HIV-2 (-)
NP HIV-1 positive
Positive HIV-1 (-)
HIV-2 (+)
NP HIV-2 positive
Positive HIV-1 (+)
HIV-2 (+)
NP HIV positive
(untypable)
Positive HIV-1/2 negative
or indeterminate
Positive Acute HIV-1 infection
Positive HIV-1/2 negative
or indeterminate
Negative Negative for HIV-1

  • Reference [1]
Oral PrEP Lab Recommendations (CDC 2021)
Initial visit
  • HIV test
    • HIV-1/2 antibody/antigen plasma test is preferred
    • Point of care rapid blood test may be used, but a plasma sample should also be ordered at the same time. Saliva tests are not recommended.
    • If the patient reports HIV exposure-prone event and acute HIV symptoms in the prior 4 weeks, HIV-1/2 antibody/antigen plasma test and HIV NAT should be ordered.
  • Creatinine clearance
  • Syphilis testing (RPR)
  • Gonorrhea
  • Chlamydia
  • Lipid panel
  • Hepatitis B
  • Hepatitis C in MSM, transgender women, and people who inject drugs
Treatment monitoring
  • HIV testing
    • HIV-1/2 antibody/antigen plasma test every 3 months. The 2021 update also recommends HIV-1 NAT every 3 months because antibody development from acute infection may be delayed in patients who are receiving PrEP. Some experts have questioned the cost-effectiveness of this recommendation since NATs are expensive.
  • Creatinine clearance
    • Age ≥ 50 or CrCl < 90 ml/min on initial testing: every 6 months
    • Age < 50 and CrCl ≥ 90 ml/min on initial testing: every 12 months
  • Syphilis, gonorrhea, and chlamydia
    • MSM and transgender women: every 3 months
    • All others: every 6 months
  • Lipid panel - every 12 months
  • Hepatitis C - every 12 months in MSM, transgender women, and people who inject drugs
  • Reference [1]
Injectable PrEP Lab Recommendations (CDC 2021)
Initial visit
  • HIV test
    • HIV-1/2 antibody/antigen plasma test is preferred
    • Point of care rapid blood test may be used, but a plasma sample should also be ordered at the same time. Saliva tests are not recommended.
    • If the patient reports HIV exposure-prone event and acute HIV symptoms in the prior 4 weeks, HIV-1/2 antibody/antigen plasma test and HIV NAT should be ordered.
  • Syphilis testing (RPR)
  • Gonorrhea
  • Chlamydia
Treatment monitoring
  • HIV testing
    • HIV-1/2 antibody/antigen plasma test and HIV-1 NAT one month after initial injection and every 2 months thereafter
  • Syphilis
    • MSM and transgender women: every 4 months
    • All sexually-active others: every 6 months
  • Gonorrhea
    • MSM and transgender women: every 4 months
    • All sexually-active others: every 6 months
  • Chlamydia
    • MSM and transgender women: every 4 months
    • All sexually-active others: every 12 months

  • Reference [2]
NPEP Lab Recommendations (CDC 2016)
Initial testing
  • NOTE: all initial testing should also be performed on source patient if able
  • HIV-1/2 antibody/antigen plasma test
  • Hepatitis B
  • Hepatitis C
  • Creatinine clearance and liver enzymes (ALT, AST) if prescribed F/TDF
  • Syphilis testing (RPR) if sexual exposure
  • Gonorrhea if sexual exposure
  • Chlamydia if sexual exposure
  • Pregnancy if sexual exposure

4 - 6 weeks after exposure
  • HIV-1/2 antibody/antigen plasma test
  • Creatinine clearance and liver enzymes (ALT, AST) if prescribed F/TDF
  • Syphilis testing (RPR) if sexual exposure
  • Gonorrhea if sexual exposure
  • Chlamydia if sexual exposure
  • Pregnancy if sexual exposure

3 months after exposure
  • HIV-1/2 antibody/antigen plasma test

6 months after exposure
  • HIV-1/2 antibody/antigen plasma test
  • Hepatitis B
  • Hepatitis C
  • Syphilis testing (RPR) if sexual exposure






  • References [2,4]
NPEP treatment regimens (CDC 2016)
Adults and adolescents ≥ 13 years, including pregnant women, with CrCl ≥ 60 ml/min
  • Preferred: F/TDF once daily with one of the following for 28 days:
    • Raltegravir 400 mg twice daily
      • OR
    • Dolutegravir 50 mg once daily

  • Alternative: F/TDF once daily with both of the following for 28 days:
    • Darunavir 800 mg once daily
    • Ritonavir 100 mg once daily
Adults and adolescents ≥ 13 years with CrCl ≤ 59 ml/min
  • Preferred: Zidovudine and lamivudine (see dosing below) with one of the following for 28 days:
    • Raltegravir 400 mg twice daily
      • OR
    • Dolutegravir 50 mg once daily

  • Alternative: Zidovudine and lamivudine (see dosing below) with both of the following for 28 days:
    • Darunavir 800 mg once daily
    • Ritonavir 100 mg once daily
Zidovudine dosing
  • Adults and adolescents ≥ 13 years weighing ≥ 66 lbs (30 kg)
    • CrCl ≥ 15 ml/min: 300 mg twice daily
    • CrCl < 15 ml/min or hemodialysis or peritoneal dialysis: 100 mg every 6 - 8 hours

Lamivudine dosing
  • Adults and adolescents ≥ 13 years weighing ≥ 55 lbs (25 kg)
    • CrCl ≥ 50 ml/min: 150 mg twice daily or 300 mg once daily
    • CrCl 30 - 49 ml/min 150 mg once daily
    • CrCl 15 - 29 ml/min 150 mg first dose, then 100 mg once daily
    • CrCl 5 - 14 ml/min 150 mg first dose, then 50 mg once daily
    • CrCl < 5 ml/min 50 mg first dose, then 25 mg once daily







  • Reference [4]
Side effect Descovy
(N=2694)
Truvada
(N=2693)
Diarrhea 5% 6%
Nausea 4% 5%
Headache 2% 2%
Fatigue 2% 3%
Abdominal pain 2% 3%


  • References [1,4]
Truvada Drug Interactions
Contraindicated drugs
  • Adefovir (Hepsera®) - DO NOT COMBINE. Adefovir may increase TDF exposure.
Drug interactions
  • NSAIDs - NSAIDs may increase the risk of TDF-associated renal toxicity. High-dose or multiple NSAIDs may increase F/TDF exposure. Use caution when combining.
  • Antivirals (Acyclovir, valacyclovir, cidofovir, ganciclovir, valganciclovir) - emtricitabine and TDF are eliminated in the kidneys through glomerular filtration and active tubular secretion. Antiviral agents that are also eliminated through active renal tubular secretion may increase F/TDF exposure and vice versa. Use caution when combining.
  • Hepatitis C drugs - Epclusa (sofosbuvir + velpatasvir), VOSEVI (sofosbuvir + velpatasvir + voxilaprevir), and HARVONI (ledipasvir + sofosbuvir) may increase exposure to TDF. Monitor for TDF toxicity when combining.
  • Aminoglycosides (e.g. gentamicin) - emtricitabine and TDF are eliminated in the kidneys through glomerular filtration and active tubular secretion. Aminoglycosides that are also eliminated through active renal tubular secretion may increase F/TDF exposure and vice versa. Use caution when combining.
  • Feminizing hormones (spironolactone, estrogens) - feminizing hormones may cause lower rectal tissue levels of TDF. It's unknown if this reduces PrEP effectiveness. TDF does not affect hormone levels.
Relevant drugs that do not interact with Truvada

  • References [1,4]
Descovy Drug Interactions
Contraindicated drugs
  • Antimycobacterials (rifabutin, rifampin, rifapentine) - DO NOT COMBINE. Antimycobacterials decrease TAF exposure.
  • St. John's wort - DO NOT COMBINE. St. John's wort decreases TAF exposure.
Drug interactions
  • NSAIDs - NSAIDs may increase the risk of TAF-associated renal toxicity. High-dose or multiple NSAIDs may increase F/TAF exposure. Use caution when combining.
  • P-glycoprotein inducers and inhibitors - TAF is a P-glycoprotein substrate. P-glycoprotein inducers may decrease TAF absorption and reduce its effectiveness. Drugs that inhibit P-glycoprotein and BCRP may increase exposure to TAF.
  • Antivirals (Acyclovir, valacyclovir, cidofovir, ganciclovir, valganciclovir) - emtricitabine and TAF are eliminated in the kidneys through glomerular filtration and active tubular secretion. Antiviral agents that are also eliminated through active renal tubular secretion may increase F/TAF exposure and vice versa. Use caution when combining.
  • Aminoglycosides (e.g. gentamicin) - emtricitabine and TAF are eliminated in the kidneys through glomerular filtration and active tubular secretion. Aminoglycosides that are also eliminated through active renal tubular secretion may increase F/TAF exposure and vice versa. Use caution when combining.
  • Anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin) - carbamazepine, oxcarbazepine, phenobarbital, and phenytoin may decrease TAF exposure and reduce its effectiveness. Consider using an alternative anticonvulsant when combining.
Relevant drugs that do not interact with Descovy






  • Includes pain (98%), nodules (15%), induration (15%), swelling (12%), brusing (4%), erythema (4%), and itching (3%)
  • Reference [4]
Side effect Cabotegravir
(N=2281)
Truvada
(N=2285)
Injection site reactions 82% 35%
(placebo injection)
Diarrhea 4% 5%
Headache 4% 3%
Pyrexia 4% <1%
Fatigue 4% 2%
Sleep disorders 3% 3%
Nausea 3% 5%
Dizziness 2% 3%


  • References [1,4]
Cabotegravir Drug Interactions
Contraindicated drugs
  • Anticonvulsants - DO NOT COMBINE cabotegravir with the following anticonvulsants because they reduce its exposure.
    • Carbamazepine
    • Oxcarbazepine
    • Phenobarbital
    • Phenytoin

  • Rifampin and rifapentine - DO NOT COMBINE. Rifampin and rifapentine reduce cabotegravir exposure.

  • Strong UGT1A1 or 1A9 inducers - DO NOT COMBINE. Cabotegravir is primarily metabolized by UGT1A1 with some contribution from UGT1A9. Strong inducers of UGT1A1 or 1A9 decrease cabotegravir exposure.
Drug interactions
  • Rifabutin - rifabutin may decrease cabotegravir exposure. When rifabutin is started before or concomitantly with the first injection of cabotegravir, the recommended dosing of cabotegravir is 600 mg initially, followed by 600 mg 2 weeks later, and then 600 mg monthly thereafter while on rifabutin. When rifabutin is started at the time of the second injection or later, the recommended cabotegravir dosing is 600 mg monthly while on rifabutin. After stopping rifabutin, cabotegravir dosing may return to every 2 months.

  • Methadone - cabotegravir may decrease methadone exposure. No dose adjustment is recommended when initiating cabotegravir; however, patients should be monitored for a decrease in methadone effectiveness, and necessary dose adjustments should be made.
Relevant drugs that do not interact with cabotegravir
  • Antiretrovirals after cabotegravir - cabotegravir has a long half-life (5 - 12 weeks) and may remain detectable in blood for 12 months or longer after discontinuation. These residual concentrations are not expected to affect antiretrovirals that are started during this period.
  • Oral contraceptives - OCPs containing levonorgestrel and ethinyl estradiol



  • References [2,4]
Quick Prescribing Guide for NPEP Meds
F/TDF (Truvada®)
Raltegravir (Isentress®) [Prescribing information]
  • Dosage forms - 400 mg and 600 mg tablet
  • Side effects - generally mild (< 5%); insomnia, nausea, fatigue, headache; severe skin and hypersensitivity reactions have been reported
  • Contraindications / precautions - none
  • Drug interactions
    • Rifampin - rifampin reduces raltegravir exposure. The recommended dosage of raltegravir is 800 mg twice daily during coadministration with rifampin.
    • Antacids, laxatives, and other products containing polyvalent cations - co-administration with antacids, laxatives, or other products containing polyvalent cations (Mg, Al, Fe, Ca, Zn), including iron, calcium, or magnesium supplements; sucralfate; buffered medications; and certain oral multivitamins can reduce absorption of raltegravir. Raltegravir should be administered ≥ 2 hours before or ≥ 6 hours after administration of cation-containing medications or products, however, raltegravir can be co-administered with calcium carbonate-containing antacids.
  • Cost - No generic/$$$$
Dolutegravir (Tivicay®) [Prescribing information]
  • Dosage forms - 10, 25, and 50 mg tablet
  • Side effects - generally mild (< 3%); insomnia, headache
  • Contraindications - concomitant dofetilide
  • Drug interactions
    • Dofetilide - DO NOT COMBINE. Dolutegravir increases dofetilide levels.
    • Oxcarbazepine, Phenytoin, Phenobarbital, St. John’s wort - DO NOT COMBINE. Dolutegravir exposure is decreased.
    • Carbamazepine - carbamazepine reduces dolutegravir exposure. Increase dose of dolutegravir to 50 mg twice daily while combining.
    • Antacids, laxatives, and other products containing polyvalent cations - co-administration with antacids, laxatives, or other products containing polyvalent cations (Mg, Al, Fe, Ca, Zn), including iron, calcium, or magnesium supplements; sucralfate; buffered medications; and some oral multivitamins can reduce absorption of dolutegravir. Dolutegravir should be administered ≥ 2 hours before or at ≥ 6 hours after administration of cation-containing medications or products.
    • Metformin - dolutegravir may increase metformin exposure. Limit total daily dose of metformin to 1000 mg when combining.
    • Rifampin - rifampin reduces dolutegravir exposure. The recommended dosage of dolutegravir is 50 mg twice daily during coadministration with rifampin.
  • Cost - No generic/$$$$
Zidovudine (Retrovir®) [Prescribing information]
  • Dosage forms - 100 mg capsule and 300 mg tablet
  • Side effects - headache, malaise, nausea, decreased appetite
  • Contraindications / Precautions
    • Concomitant doxorubicin - DO NOT COMBINE doxorubicin with zidovudine
    • Bone marrow suppression - zidovudine may cause hematologic toxicity in some patients. Reduced hemoglobin may occur as early as 2 - 4 weeks after initiation, and neutropenia may occur after 6 - 8 weeks.
  • Drug interactions
    • Doxorubicin - DO NOT COMBINE
    • Bone marrow suppressive agents (e.g. ganciclovir, interferon alfa, ribavirin) - bone marrow suppressive agents may potentiate the hematologic toxicity of zidovudine
  • Cost - Generic/$
Lamivudine (Epivir®) [Prescribing information]
  • Dosage forms - 150 and 300 mg tablet
  • Side effects - headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough
  • Contraindications / Precautions
    • Hepatitis B infection - exacerbation of hepatitis B infection may occur after discontinuation of lamivudine. Lamivudine may be used in NPEP regimens for patients with chronic hepatitis B infection, but hepatic function tests should be monitored when stopping.
  • Drug interactions
    • Emtricitabine - DO NOT COMBINE. Efficacy of both drugs may be reduced.
    • Organic Cation Transporter (OCT) inhibitors - lamivudine is primarily eliminated by OCT. Drugs that inhibit OCT may increase lamivudine levels.
    • Sorbitol - coadministration of lamivudine with sorbitol reduces lamivudine absorption
  • Cost - Generic/$$
Darunavir (Prezista®) [Prescribing information]
  • Dosage forms - 75, 150, 600, 800 mg tablet
  • Side effects - rash (sulfonamide allergy), diarrhea, nausea, headache
  • Contraindications / Precautions
    • Must be given with ritonavir and food - darunavir must be administered with ritonavir and food in order to be effective. Ritonavir is a strong CYP3A4 inhibitor and has many drug contraindications.
    • Hepatotoxicity - in preclinical studies (N=3063), drug-induced hepatitis occurred in 0.5% of darunavir/ritonavir-treated patients. Use caution in patients with liver disease.
    • Severe skin reactions - in preclinical studies (N=3063), severe skin reactions (e.g. Stevens-Johnson Syndrome, DRESS) occurred in 0.4% of darunavir/ritonavir-treated patients. Darunavir should be stopped immediately if unusual rashes or systemic symptoms (e.g. fever, myalgia) occur.
    • Sulfa allergy - darunavir contains a sulfonamide moiety. Use caution in patients with a history of sulfa allergy.
  • Drug interactions
    • Darunavir must be given with ritonavir, a strong CYP3A4 inhibitor. The list of potential drug interactions is extensive. See Darunavir PI [sec 7] for more information.
  • Cost - No generic/$$$$
Ritonavir (Norvir®) [Prescribing information]
  • Dosage forms - 100 mg tablet
  • Side effects - abdominal pain, asthenia, headache, malaise, anorexia, diarrhea, dyspepsia, nausea, vomiting, circumoral paresthesia, peripheral paresthesia, dizziness, and taste perversion
  • Contraindications / Precautions
    • CYP3A4 substrates - ritonavir is a strong CYP3A4 inhibitor and is contraindicated with a number of medications
    • Hepatotoxicity - hepatotoxicity has occurred in patients receiving ritonavir. Use caution in patients with liver disease.
    • Pancreatitis - pancreatitis has been reported in patients receiving ritonavir. If patients develop symptoms of pancreatitis (e.g. abdominal pain, nausea, vomiting), ritonavir should be stopped.
    • Severe skin reactions - severe skin reactions (e.g. Stevens-Johnson Syndrome, toxic epidermal necrolysis) have occurred in patients receiving ritonavir. Ritonavir should be stopped immediately if unusual rashes or systemic symptoms (e.g. fever, myalgia) develop.
    • Prolonged PR interval - ritonavir prolongs the PR interval in some patients. Use caution in patients with heart disease, conduction abnormalities, and/or in those taking other PR-prolonging drugs (e.g. calcium channel blockers, beta blockers).
  • Drug interactions
    • Ritonavir is a strong CYP3A4 inhibitor. The list of potential drug interactions is extensive. See Ritonavir PI [sec 7] for more information.
    • Drugs that prolong the QT interval - ritonavir may prolong the QT interval. Use caution when combining with other QT-prolonging drugs.
  • Cost - Generic/$-$$






  • Rash in acute HIV is typically a symmetrical, maculopapular, erythematous exanthem affecting the face, palms, soles, trunk, and limbs.
  • Reference [1]
Symptoms of acute HIV infection
Symptom % affected
Fever 75%
Fatigue 68%
Myalgia 49%
Skin rash 48%
Headache 45%
Pharyngitis 40%
Cervical adenopathy 39%
Arthralgia 30%
Night sweats 28%
Diarrhea 27%


Pricing legend
  • $ = 0 - $50
  • $$ = $51 - $100
  • $$$ = $101 - $150
  • $$$$ = > $150
  • Pricing based on one month of therapy at standard dosing in an adult
  • Pricing based on information from GoodRX.com®
  • Pricing may vary by region and availability