Feature

Q&A: PCPs play ‘vital role’ in combating HIV epidemic

Photo of Joshua Khalili
Joshua Khalili

PCPs play a major role in ending the HIV epidemic, according to a special communication published recently in JAMA Internal Medicine.

The communication urges PCPs to take on the responsibility of prescribing pre-exposure prophylaxis (PrEP) for their patients because HIV-negative individuals who are at risk for the disease are more likely to visit a PCP than a specialist.

In honor of World AIDS Day, Healio Primary Care spoke with Joshua Khalili, MD, AAHIVS, lead author of the special communication and an extensivist physician at UCLA Santa Monica, about what PCPs should know about prescribing PrEP and the importance of their role in helping to end the HIV epidemic. by Erin Michael

Q: What is the “purview paradox,” and what is the solution?

 
PCPs play a major role in ending the HIV epidemic, according to a special communication published recently in JAMA Internal Medicine.
Source: Adobe Stock

A: Who should prescribe PrEP? The "purview paradox" is a term applied to an issue we have seen with PrEP implementation where there may be some confusion regarding who the most appropriate clinicians are to prescribe PrEP. Since the components of PrEP are also medications used to treat HIV, some believe that HIV or infectious disease specialists are most appropriate to prescribe PrEP. However, while they may not be familiar with prescribing the medication, PCPs are most likely to see individuals who are HIV-negative and eligible for PrEP. While we continue to rely on our infectious disease colleagues for their expertise, PCPs play the vital role in scaling up the use of PrEP to help end HIV.

Q: How should PCPs approach discussions about HIV risk assessment with their patients?

A: It's best that discussions around HIV risk are framed as part of an open-ended and nonjudgmental discussion of overall sexual health with all patients. PCPs can use the fact-based risk assessment guide outlined in our article to appropriately identify who may be eligible for PrEP. The risk assessment may also be provided via paper-based questionnaires or integrated into the electronic medical record to be completed by patients prior to face-to-face encounters with clinicians.

Q: What clinical history and laboratory results indicate that a patient should be prescribed PrEP?

A: There are a number of factors in a patient's clinical history that should be considered when assessing their risk for HIV and thus their eligibility for PrEP. These factors are associated with sexual behavior, including the type of sex individuals engage in, condom use, IV drug or substance use that may be associated with high-risk behavior, and history of bacterial STIs. If an individual answers "yes" to any of the questions outlined in the clinical history risk assessment, then they should be offered PrEP, and a baseline clinical assessment with laboratory testing should be conducted. Notably, PCPs may encounter individuals who request PrEP though may not necessarily meet the criteria based on the risk assessment; PrEP eligibility should be determined on a case-by-case basis for these individuals as they may be at increased risk for HIV though not comfortable disclosing these risk factors.

Once an individual is deemed to be eligible for PrEP based on the conducted risk assessment, it is recommended that they are screened for symptoms associated with acute HIV — pharyngitis, rash, diarrhea, fevers, oral or genital ulcers in an individual with recent potential exposure to HIV — as individuals who may have acute HIV should not be prescribed PrEP, and HIV RNA testing should be conducted. Otherwise, the following baseline tests are recommended: fourth-generation HIV Ag/Ab laboratory test, assessment of renal function (with creatinine clearance [CrCl]), hepatitis B surface antigen testing to assess for active hepatitis B infection, hepatitis C virus antibody testing, pregnancy testing if applicable, and STI testing for gonorrhea, chlamydia — oral, urine, vaginal and/or rectal — and syphilis. It is recommended that results for HIV testing be confirmed (negative) prior to prescribing PrEP; furthermore, PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is not recommended for individuals with a CrCl less than 60. PrEP with tenofovir alafenamide/emtricitabine (TAF/FTC) which was recently FDA-approved, may be considered for individuals with a CrCl less than 60 who have nonvaginal exposures to HIV.

Following up with patients after prescribing PrEP is important. At 1 month, an ambulatory visit is recommended to check in with patients regarding barriers to adherence, potential side effects and for repeat HIV testing. HIV, STI and pregnancy testing should be repeated every 3 months along with a refill of a 90-day prescription of TDF/FTC. Renal function should be assessed with CrCl every 6 months; however, if risk factors that increase the risk of renal dysfunction are present — including age older than 50 years, diagnoses of diabetes, hypertension, or baseline CrCl less than 90 — then CrCl should be assessed quarterly.

Q: Should physicians prescribe PrEP differently for men and women?

A: If considered eligible based on the risk and clinical assessments, individuals should be prescribed daily TDF/FTC for PrEP. All patients should be advised that there is a 7-day "lead-in" time for PrEP to gain optimal levels of concentration in tissues for individuals having anal and/or vaginal sex. For men who have sex with men (MSM) there are data that demonstrate safety and efficacy of using what is called "2-1-1," or "event-driven" PrEP. In this method, individuals are recommended to take two tablets of TDF/FTC 2 to 24 hours before sex, one tablet 24 hours after the first dose and one more tablet 24 hours later. This is a strategy that can be advised to MSM who can successfully plan or anticipate sexual intercourse. Otherwise, individuals — regardless of gender — prescribed PrEP should be advised to simply take one tablet, once a day.

Q: What adverse events associated with PrEP should physicians be aware of?

A: The most common adverse event associated with TDF/FTC for PrEP is mild gastrointestinal discomfort that typically resolves soon — 2 to 4 weeks after initiation — and can be managed with supportive care. Renal toxicity is a potential concern though uncommon, with no significant differences in clinical outcomes among large populations of individuals on daily TDF/FTC compared to placebo. Importantly, renal function should be assessed at baseline, 3 months after initiation, then every 6 months thereafter, and every 3 months for individuals with risk factors of renal dysfunction as described above. Finally, bone disease is a potential concern as we do know that bone density loss does occur with the use of TDF/FTC for PrEP; however, this loss is reversible upon discontinuation of PrEP, and long-term data on clinical outcomes is limited. Clinicians may consider prescribing TAF/FTC for PrEP for individuals with nonvaginal exposures to HIV who have high risk for, or known, bone disease.

Q: When should PCPs consider consulting a specialist before prescribing PrEP?

A: It may be beneficial for PCPs to consult an infectious disease specialist when prescribing PrEP for individuals with chronic or active hepatitis B infection, as PrEP discontinuation in individuals with chronic, suppressed infection may result in hepatitis flare. Though very rare, there is concern for PrEP "failure," which is typically the acquisition of HIV in the setting of nonadherence. When HIV is acquired by individuals on PrEP with a high level of adherence, it is typically in the setting of the transmission of HIV that is resistant to the component(s) of PrEP. In these cases, given that individuals may still be taking TDF/FTC, HIV status may be difficult to ascertain given potential discordance of test results and warrants expert consultation.

PrEP with TDF/FTC is safe, effective and easy to prescribe. PCPs play a crucial role in the delivery of PrEP to those who are eligible in the effort to end the HIV epidemic.

Reference:

Khalili J, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2019.5456.

Disclosures: Khalili reports no relevant financial disclosures. Please see the special communication for all other authors’ relevant financial disclosures.

Photo of Joshua Khalili
Joshua Khalili

PCPs play a major role in ending the HIV epidemic, according to a special communication published recently in JAMA Internal Medicine.

The communication urges PCPs to take on the responsibility of prescribing pre-exposure prophylaxis (PrEP) for their patients because HIV-negative individuals who are at risk for the disease are more likely to visit a PCP than a specialist.

In honor of World AIDS Day, Healio Primary Care spoke with Joshua Khalili, MD, AAHIVS, lead author of the special communication and an extensivist physician at UCLA Santa Monica, about what PCPs should know about prescribing PrEP and the importance of their role in helping to end the HIV epidemic. by Erin Michael

Q: What is the “purview paradox,” and what is the solution?

 
PCPs play a major role in ending the HIV epidemic, according to a special communication published recently in JAMA Internal Medicine.
Source: Adobe Stock

A: Who should prescribe PrEP? The "purview paradox" is a term applied to an issue we have seen with PrEP implementation where there may be some confusion regarding who the most appropriate clinicians are to prescribe PrEP. Since the components of PrEP are also medications used to treat HIV, some believe that HIV or infectious disease specialists are most appropriate to prescribe PrEP. However, while they may not be familiar with prescribing the medication, PCPs are most likely to see individuals who are HIV-negative and eligible for PrEP. While we continue to rely on our infectious disease colleagues for their expertise, PCPs play the vital role in scaling up the use of PrEP to help end HIV.

Q: How should PCPs approach discussions about HIV risk assessment with their patients?

A: It's best that discussions around HIV risk are framed as part of an open-ended and nonjudgmental discussion of overall sexual health with all patients. PCPs can use the fact-based risk assessment guide outlined in our article to appropriately identify who may be eligible for PrEP. The risk assessment may also be provided via paper-based questionnaires or integrated into the electronic medical record to be completed by patients prior to face-to-face encounters with clinicians.

Q: What clinical history and laboratory results indicate that a patient should be prescribed PrEP?

A: There are a number of factors in a patient's clinical history that should be considered when assessing their risk for HIV and thus their eligibility for PrEP. These factors are associated with sexual behavior, including the type of sex individuals engage in, condom use, IV drug or substance use that may be associated with high-risk behavior, and history of bacterial STIs. If an individual answers "yes" to any of the questions outlined in the clinical history risk assessment, then they should be offered PrEP, and a baseline clinical assessment with laboratory testing should be conducted. Notably, PCPs may encounter individuals who request PrEP though may not necessarily meet the criteria based on the risk assessment; PrEP eligibility should be determined on a case-by-case basis for these individuals as they may be at increased risk for HIV though not comfortable disclosing these risk factors.

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Once an individual is deemed to be eligible for PrEP based on the conducted risk assessment, it is recommended that they are screened for symptoms associated with acute HIV — pharyngitis, rash, diarrhea, fevers, oral or genital ulcers in an individual with recent potential exposure to HIV — as individuals who may have acute HIV should not be prescribed PrEP, and HIV RNA testing should be conducted. Otherwise, the following baseline tests are recommended: fourth-generation HIV Ag/Ab laboratory test, assessment of renal function (with creatinine clearance [CrCl]), hepatitis B surface antigen testing to assess for active hepatitis B infection, hepatitis C virus antibody testing, pregnancy testing if applicable, and STI testing for gonorrhea, chlamydia — oral, urine, vaginal and/or rectal — and syphilis. It is recommended that results for HIV testing be confirmed (negative) prior to prescribing PrEP; furthermore, PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is not recommended for individuals with a CrCl less than 60. PrEP with tenofovir alafenamide/emtricitabine (TAF/FTC) which was recently FDA-approved, may be considered for individuals with a CrCl less than 60 who have nonvaginal exposures to HIV.

Following up with patients after prescribing PrEP is important. At 1 month, an ambulatory visit is recommended to check in with patients regarding barriers to adherence, potential side effects and for repeat HIV testing. HIV, STI and pregnancy testing should be repeated every 3 months along with a refill of a 90-day prescription of TDF/FTC. Renal function should be assessed with CrCl every 6 months; however, if risk factors that increase the risk of renal dysfunction are present — including age older than 50 years, diagnoses of diabetes, hypertension, or baseline CrCl less than 90 — then CrCl should be assessed quarterly.

Q: Should physicians prescribe PrEP differently for men and women?

A: If considered eligible based on the risk and clinical assessments, individuals should be prescribed daily TDF/FTC for PrEP. All patients should be advised that there is a 7-day "lead-in" time for PrEP to gain optimal levels of concentration in tissues for individuals having anal and/or vaginal sex. For men who have sex with men (MSM) there are data that demonstrate safety and efficacy of using what is called "2-1-1," or "event-driven" PrEP. In this method, individuals are recommended to take two tablets of TDF/FTC 2 to 24 hours before sex, one tablet 24 hours after the first dose and one more tablet 24 hours later. This is a strategy that can be advised to MSM who can successfully plan or anticipate sexual intercourse. Otherwise, individuals — regardless of gender — prescribed PrEP should be advised to simply take one tablet, once a day.

PAGE BREAK

Q: What adverse events associated with PrEP should physicians be aware of?

A: The most common adverse event associated with TDF/FTC for PrEP is mild gastrointestinal discomfort that typically resolves soon — 2 to 4 weeks after initiation — and can be managed with supportive care. Renal toxicity is a potential concern though uncommon, with no significant differences in clinical outcomes among large populations of individuals on daily TDF/FTC compared to placebo. Importantly, renal function should be assessed at baseline, 3 months after initiation, then every 6 months thereafter, and every 3 months for individuals with risk factors of renal dysfunction as described above. Finally, bone disease is a potential concern as we do know that bone density loss does occur with the use of TDF/FTC for PrEP; however, this loss is reversible upon discontinuation of PrEP, and long-term data on clinical outcomes is limited. Clinicians may consider prescribing TAF/FTC for PrEP for individuals with nonvaginal exposures to HIV who have high risk for, or known, bone disease.

Q: When should PCPs consider consulting a specialist before prescribing PrEP?

A: It may be beneficial for PCPs to consult an infectious disease specialist when prescribing PrEP for individuals with chronic or active hepatitis B infection, as PrEP discontinuation in individuals with chronic, suppressed infection may result in hepatitis flare. Though very rare, there is concern for PrEP "failure," which is typically the acquisition of HIV in the setting of nonadherence. When HIV is acquired by individuals on PrEP with a high level of adherence, it is typically in the setting of the transmission of HIV that is resistant to the component(s) of PrEP. In these cases, given that individuals may still be taking TDF/FTC, HIV status may be difficult to ascertain given potential discordance of test results and warrants expert consultation.

PrEP with TDF/FTC is safe, effective and easy to prescribe. PCPs play a crucial role in the delivery of PrEP to those who are eligible in the effort to end the HIV epidemic.

Reference:

Khalili J, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2019.5456.

Disclosures: Khalili reports no relevant financial disclosures. Please see the special communication for all other authors’ relevant financial disclosures.