CDC Guidelines on Antiretroviral Preexposure Prophylaxis to Prevent HIV in Those at Risk
SUMMARY:
The CDC has published updated guidelines on the use of PrEP – a pharmacologic approach to reduce HIV risk. Guidelines now simplify counseling recommendations to include all sexually active adolescents and adults, and higher risk groups should be routinely prescribed PrEP. PrEP medication options are also expanding with two approved daily oral antiretroviral preexposure prophylaxis (PrEP) medications and an intramuscular antiretroviral medication pending FDA approval.
CDC Guidance
General Counseling and Offering of PrEP
All sexually active adults
Should be counseled on risks of STI, including HIV
Should be informed about PrEP to improve general awareness
PrEP can be prescribed after options-counseling to
All HIV negative individuals who are interested and request PrEP and
Weigh at least 35kg (77 lb)
Higher Risk Populations
PrEP should be routinelyprescribed for all persons who are HIV negative and are at on-going higher risk for transmission of HIV, defined as
Sexually active patients (anal or vaginal sex in the past six months) AND one of the following risk factors
HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
1 or more sexual partners with unknown HIV status without consistent use of condoms or
Diagnosed with bacterial STI in the past 6 months | MSM diagnosed with gonorrhea, chlamydia, or syphilis | MSW and WSM diagnosed with GC or syphilis
Persons without HIV who have injected drugs in the past 6 months and
HIV+ injecting partner or
Sharing injection equipment
Persons who have been prescribed PEP (post-exposure prophylaxis) and
report continued risk behavior or
have used multiple courses of PEP
USPSTF Guidance (June 2019)
The USPSTF recommendations do not yet reflect updated CDC guidance and currently recommends only offering PrEP to persons at high risk of HIV acquisition. This recommendation is Grade A, which means that PrEP should be offered or provided in the appropriate clinical settings (see below). In addition, the USPSTF document states that while PrEP is associated with “small harms” (e.g., kidney and GI events), overall
The USPSTF found convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.
What is PrEP
PrEP is an anti-retroviral medication (or medications) to prevent the transmission of HIV and not recommended for the treatment of HIV
Oral Formulations
Oral pill taken daily
Emtricitabine (F) 200 mg and tenofovir disoproxil fumarate (TDF) 300 mg (F/TDF, Truvada) to prevent HIV infection among all persons at risk through sex or injection drug use
Emtricitabine (F) 200 mg tenofovir alafenamide (TAF) 25 mg tablet (F/TAF, Descovy) taken daily to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex because due to lack of studies for this indication
Effectiveness estimates
Sexual transmission route: approximately 99% effective
Injection drug use: 74 to 84% effective (based on tenofovir alone and may be higher with combination pill)
Effectiveness strongly related to adherence to PrEP
Intramuscular Formulation
Cabotegravir (600mg) is an IM injection in the gluteal muscle recommended (conditional on FDA approval) every 2 months
In persons concerned about side effects, can consider a 30mg daily oral cabotegravir for a 4-week lead-in prior to injections
Clinical Actions
Clinical eligibility
HIV testing confirming negative status before starting PrEP
No signs/symptoms of acute HIV infection
No contraindication or allergies to medications
Recommended laboratory testing based on oral PrEP regimen versus IM PrEP regimen
Document pregnancy intention
Screen/treat STIs
Recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors as well as STI testing, pregnancy testing, and additional laboratory results
Reinforce the importance of adherence and HIV risk reduction, including encouraging condom use for additional protection
While on oral PrEP, requires assessment of renal function at 3 months and every 6 months after, using Cockcroft-Gault formula
F/TDF: Approved for use in persons with eCrCl >60 ml/min
F/TAF: Approved for use in persons with eCrCl ≥30 ml/min
While on IM PrEP, does not require assessment of renal or liver function
STI screening should be administered every 6 months even if asymptomatic
Stop PrEP if
Patient requests to stop | Counsel regarding other preventative measures
Patient now HIV positive | Manage or refer for treatment
Dosage
Initiation of oral PrEP
Daily oral pill of F/TDF or F/TAF prescription
Limit prescription to a 90 day corresponding to every 3 month HIV testing
Prior to prescription, laboratory assessment requirements includes renal infection, hepatitis B virus infection, and lipid profile (F/TAF)
Side effects in clinical trials were mild | early side effects include mild GI distress that resolved the first month or headache
Serious side effects are rare however can impair renal function | Serum creatinine monitoring required
Liver function can be adversely affected and patients should report symptoms (e.g. tea colored urine, light colored stool etc.)
Intramuscular Regimen
Administration of cabotegravir 600mg via one 3mL intramuscular injection in the gluteal muscle | Initiation of cabotegravir requires a second dose 4 weeks after the first dose (one month follow up visit) and every 8 weeks after with HIV testing at visits
Can consider trial of cabotegravir 30mg daily for four weeks prior to initiation of IM injections if patients are anxious about side effects
Schedule is initial administration (month 0), one month after initiation (month 1), then every 8 weeks afterwards (month 3, 5, 7, etc.)
Follow-up visit one month after initial injection should include second dose and HIV Ag/Ab test and HIV-1 RNA assay with subsequent 2-month intervals
The following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use
Creatinine or eCrCl
hepatitis B serology
lipid panels
liver function tests
Minimal side effects were noted
PrEP Maintenance
Patients on PrEP should return to their health care provider every 3 months with oral PrEP and every 2 months for intramuscular PrEP and should include:
HIV testing to ensure sero-negative
Prescription refill
Assess and counseling regarding medication adherence and risk reduction behaviors
Laboratory testing including STIs and pregnancy
Address any concerns, including side effects
Renal Assessment required for oral daily dosing of PrEP but not IM dosing of PrEP
Patients <50 or with with eCrCl >90 at initiation should have renal function assessed every 12 months
Impaired renal function should trigger evaluation every 6 months
Thresholds | F/TDF: Approved for use in persons with a eCrCl >60 ml/min, F/TAF: Approved for use in persons with eCrCl ≥30 ml/min
A rise in creatinine is not a reason to withhold treatment, as long as above the threshold as above
NOTE: Renal function monitoring not required with cabotegravir
Lipid panel is recommended annually in patients taking F/TAF
Hepatitis B serology testing is only recommended at initiation of PrEP
Hepatitis C testing is recommended annually for MSM, TGW, and PWID
HIV-discordant Couples and Pregnancy
Conception and pregnancy
PrEP is one of several options to protect the partner who is HIV-negative (see related ‘ObG Topics, below) in a couple considering pregnancy
Data on use of the PrEP medication has not shown increased risk of birth defects nor risk to breastfeeding children
Breastfeeding
The CDC states that “F/TDF as PrEP is considered generally safe for pregnant and breastfeeding women”
For F/TDF, the FDA label states
The health benefits of breastfeeding and the mother’s clinical need for PrEP should be considered along with any potential adverse effects on the breastfed child from TRUVADA balanced against the risks of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission
Women should not breastfeed if acute HIV-1 infection is suspected because of the risk of HIV-1 transmission to the infant
PrEP vs PEP
PrEP is only for people who are at ongoing substantial risk of HIV infection
For a single high-risk event of potential HIV exposure (e.g., unprotected sex, needle-sharing injection drug use, or sexual assault—use postexposure prophylaxis (PEP) option, or PEP within 72 hours of exposure (see ‘Learn More – Primary Sources’ below)
KEY POINTS:
All sexually active adolescents and adults who are sexually active should be counseled on and offered PrEP regardless of risk designation
PrEP should be routinely prescribed for patients at higher risk of HIV acquisition, including:
Sexually active patients (anal or vaginal sex in the past six months) AND one of the following risk factors
HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
1 or more sexual partners with unknown HIV status without consistent use of condoms or
Diagnosed with bacterial STI in the past 6 months | MSM diagnosed with gonorrhea, chlamydia, or syphilis | MSW and WSM diagnosed with GC or syphilis
Persons without HIV who have injected drugs in the past 6 months and
Have HIV+ injection partners or
Share injection equipment
Persons who have been prescribed PEP (post-exposure prophylaxis) and
Screening & Treatment of Gynecologic infections in the HIV-Positive Woman
Gynecologic infections are more common, and may be more difficult to eradicate, in the HIV population. Overall, treatment protocols remain the same, irrespective of HIV status, although there are some differences depending on the disorder.
CLINICAL ACTIONS:
Screen at entry to care and at least annually for the following: N.gonorrhoeae, C. trachomatis, syphilis and vaginal trichomoniasis
Screen for hepatitis C on entry to care
At-risk seronegative individuals should be screened at least annually
Consider type specific HSV serologic testing for those presenting for an STD evaluation
Approximately 70% of persons with HIV are HSV-2 seropositive | 95% are seropositive for either HSV-1 or HSV-2
HSV-2 infection increases the risk of HIV acquisition two- to three-fold and in coinfected patients
HSV-2 reactivation results in increases in HIV RNA levels in blood and genital secretions
Screen on entry to care for hepatitis B with HBsAg, anti-HBc and/or anti-HBs
Offer vaccination to seronegative individuals with hepatitis B or combined hepatitis A and B vaccine
Recheck immunity after vaccination complete
SYNOPSIS:
While it is critical to remain vigilant with regard to STDs and pelvic infections, women with ulcerative conditions of the genitalia, including syphilis and herpes, are at increased risk of HIV acquisition and transmission to partners, lending an urgency to prompt treatment or suppression (see separate entry on ulcerative conditions).
KEY POINTS:
Bacterial vaginosis is more prevalent/persistent in HIV-positive women
Diagnosis and treatment options are the same
Vulvovaginal candidiasis is more common among HIV-positive women and associated with decreased CD4+ counts
Treatment is the same as for HIV-negative women
For azole-refractory Candida glabrata vaginitis
Boric acid 600 mg vaginal suppository once daily for 14 days
Note: Severe or recurrent vaginitis should be treated with oral fluconazole (100 to 200 mg) or topical antifungals for ≥7 days
Treatment for gonorrhea/chlamydia is the same as for HIV-negative women
Retest 3 months after treatment as reinfection is common
Pelvic inflammatory disease is treated with the same antimicrobials for the same duration as for HIV-negative
There is a greater incidence of tubo-ovarian abscess among HIV-positive, but overall response to therapy is the same as for HIV-negative
Trichomoniasis is more prevalent among HIV-positive and should be treated with a one week course of metronidazole
Parasitic conditions such as scabies or pediculosis pubis are treated the same regardless of HIV status
Ulcerative Genital Conditions in the HIV-Positive Woman
Genital, anal, or perianal ulcers are generally caused by syphilis or herpes. Chancroid, lymphogranuloma venereum (LGV), and granuloma inguinale (donovaniasis) are less likely diagnoses; however, all these conditions are associated with increased HIV acquisition and transmission. Guidelines for screening and treatment differ in some cases from those for the HIV-negative patient.
CLINICAL ACTIONS:
Evaluate first for herpes and syphilis first
Other causes such as chancroid and lymphogranuloma venereum should then be considered
Offer HSV type-specific serologic testing on initial HIV evaluation for asymptomatic individuals
HSV DNA polymerase chain reaction (PCR) and viral culture are preferred methods for diagnosis of mucocutaneous HSV lesions caused by HSV
Consider suppression or episodic therapy to decrease clinical manifestations if HSV-2 is detected
Does not reduce risk for HIV transmission or HSV-2 transmission to susceptible sex partners
Generally higher doses/longer duration of treatment are recommended for HIV-positive women
Daily suppression
Acyclovir 400-800 mg BID or TID
or
Valacyclovir 500 mg BID
or
Famciclovir 500 mg BID
Episodic flares
Acyclovir 400 mg TID x 5-10 days
or
Valacyclovir 1 g BID x 5-10 days
or
Famcycolovir 500 mg BID x 5-10 days
Syphilis:
Systemic disease caused by Tremonema Pallidum
Primary syphilis is characterized by genital ulcers, though secondary/ tertiary/latent forms are not
A presumptive diagnosis of syphilis requires a treponemal test (i.e fluorescent treponemal antibody absorbed tests [FTA-ABS]) plus a nontreponemal test (i.e. Venereal Disease Research Laboratory [VDRL] or Rapid Plasma Reagin [RPR])
Screen for syphilis on initial HIV evaluation and annually thereafter
Treatment is the same regardless of HIV status
Penicillin G IM is the preferred treatment for all stages; the preparation (benzathine, aqueous procaine aqueous crystalline), dosage and length of treatment depend on the stage
Chancroid:
Painful, genital ulcers with suppurative lymphadenopathy caused by ducreyi
Treatment is the same regardless of HIV status
Close follow up is required as treatment failure is increased in the HIV positive
Treatment
Azithromycin 1 gm po
or
Ceftriaxone 250 mg IM
or
Ciprofloxacin 500 mg po BID x 3 days
or
Erythromycin 500 mg tid x 7 days
Lymphogranuloma Venereum (LGV)
Tender, unilateral groin/femoral lymphadenopathy with a self-limited genital ulcer/papule caused by C. trachomatis serovars L1, L2, or L3
Proctitis may occur
Diagnose by identifying C. trachomatis from the lesion by culture, direct immunofluorescence or nucleic acid detection
Treatment is the same regardless of HIV status
Treatment
Doxycycline 100 mg BID x 3 weeks
or
Erythromycin base 500 mg QID x 3 weeks
Granuloma Inguinale (Donovanosis):
Painless ulcerative disease characterized by beefy red, highly vascular lesions caused by Klebsiella granulomatis
Diagnose by identifying dark-staining “Donovan Bodies” on biopsy or tissue
Treatment is the same regardless of HIV status
Treatment
Azithromycin 1 gm once/week or 500 mg/day x 3 weeks/until lesions healed
or
Doxycycline 100 mg BID X 3 weeks/until lesions healed
or
Ciprofloxacin 750 mg BID x 3 weeks/until lesions healed
or
Erythromycin base 500 mg QID x 3 weeks/until lesions healed
or
Trimethoprim-sulfamethoxazole double strength BID x 3 weeks/until healed
SYNOPSIS:
Vaginal, vulvar, and sexually transmitted infections may increase the risk of HIV transmission. Prompt diagnosis and treatment decreases the likelihood of transmission; public health standards require providers to presumptively treat any patient, regardless of HIV status, with suspected syphilis immediately and before test results are available. Presumptive treatment of primary herpes is also recommended as early treatment maximizes success.
KEY POINTS:
Genital, anal, or perianal lesions may not necessarily be infectious (e.g. trauma, carcinoma, aphthous, drug eruption, psoriasis)
Medical history and physical exam findings are frequently inaccurate and should be followed by tests that reflect conditions prevalent in the area
Consider biopsy for ulcers not responding to therapy or if the diagnosis is unclear
If HIV status is unknown, HIV testing should be offered to any woman with genital/anal ulcers presenting for treatment.
Diagnosis codes:
D28.9 benign neoplasm of female genital organs, unspecified
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