Guidelines for Implementing Pre-Exposure Prophylaxis For The Prevention of HIV in Youth Peter Havens, MD MS Draft: 10-2-2015 Clinical studies demonstrate that when a person without HIV infection takes Truvada daily their chance of acquiring HIV infection is greatly reduced. The CDC released guidelines for providers to implement pre-exposure prophylaxis () to prevent HIV infection. Complete recommendations can be found at http://www.cdc.gov/hiv/prevention/research/prep/ These guidelines outline one approach to implement the CDC guidelines. STEP 1: Identify Potential Candidates for The CDC suggests that may be considered for persons without HIV infection who have the following risk: 1. Persons with a partner with known HIV infection 2. Men who have sex with men (MSM) who participate in condomless anal intercourse 3. A heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or are men with male partners). 4. Persons who have injected illicit drugs in the past 6 months and (1) shared injection equipment or (2) were in drug treatment for injection drug use. The New York State Department of Health suggests may also be considered for persons without HIV infection who have the following risk: 1. Transgendered and engage in high-risk sexual behavior 2. Trading sex for money, drugs, or housing 3. Use of stimulant drugs associated with high-risk behaviors such as methamphetamine 4. More than one anogenital sexually transmitted infection (STI) in the last year 5. Have taken non-occupational post-exposure prophylaxis who participate in on-going high-risk behavior or have used post-exposure prophylaxis (PEP) multiple times. Tables in Step 2 and Step 3 provide issues to think about prior to starting. The issues may not be applicable in a specific clinic or with specific clinical situations or with every patient. Page 1 of 5
STEP 2: Baseline Assessment before Starting Tables in Step 2 and Step 3 outline issues to consider prior to starting. The issues may not be applicable in a specific clinic or with specific clinical situations or with every patient. They are provided as guidelines. Area for Assessment Specific Issues for Discussion 1. Person s understanding of Knowledge about 2. Reason why person wants to take and what it will do for them Readiness for Taking 1. Discuss importance of taking Truvada daily Daily 2. Identify potential barriers to daily adherence 3. Discuss risk of medication side effects versus risk of acquisition of HIV Primary Care Provider 1. Does person have a primary care provider if not link to primary care 2. Clarify who will prescribe and monitor Housing & Contact 1. Identify where patient will be living Information 2. Obtain several alternative methods of contacting person Payment for 1. Does person have insurance to pay for? 2. The Truvada for Medication Assistance Program assists eligible HIVnegative adults in the United States who do not have insurance to obtain Truvada for. To determine eligibility for this program, call 1-855-330-5479, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time) 3. Application for medication assistance program: https://start.truvada.com/content/pdf/medication_assistance_program.pdf Partner Information 1. If person has a known partner, determine if partner is known to have HIV infection a. If partner has HIV infection, does person know (1) if partner is taking ARVs and (2) their partner s viral load result is partner undetectable? Especially for Female 1. Does person want to become pregnant, is she currently pregnant or breastfeeding. Patients: 2. If she does not want to become pregnant make sure to clarify that she will need Obtain Clinical History to Assess for Symptoms of Acute HIV Infection: contraception. does not prevent pregnancy. 1. Is person currently or within past 1-2 months experiencing fever, feeling tired, swollen lymph nodes, sore throat, muscle and joint aches, or rash? 2. If symptoms are present, check HIV antibody/antigen screen and HIV RNA PCR Medication list: 1. Is person taking medications? 2. Check with pharmacist to evaluate current medications for potential drug-drug interactions with Truvada Page 2 of 5
STEP 3 : Education about Topic Specific Issues for Discussion How works 1. Truvada is 1 tablet but contains 2 medications used to treat persons with HIV, tenofovir and emtricitabine. 2. When a person without HIV infection is exposed to HIV these medicines work together to reduce the risk that HIV will establish an infection in the person. 3. When a person takes Truvada to prevent HIV infection it is called pre-exposure prophylaxis or. Limitations of : 1. The efficacy of to prevent HIV infection in a person depends on how well the person is able to take the medication daily. 2. reduces but does not totally eliminate the risk of HIV transmission. 3. does not protect against other STIs use 1. Explain that it may take 1 to three weeks of daily Truvada to have enough medications on board to reduce the risk of HIV infection. It is recommended that persons use condoms consistently during this time. 2. is not shown to prevent HIV infection if it is taken only just before or just after sex. 3. Discuss the importance of talking with the prescribing provider before a person decides to stop taking Truvada. Adherence 1. Discuss person s daily routine to help person identify a consistent time to take the medication daily. Some persons find it easier to remember to take their medicine if they take it when they do something they do every day (i.e. brushing their teeth) 2. Help person identify reminders to minimize forgetting doses (i.e. setting alarm on cell phone) 3. Reinforce success, recognize that there may be an occasional missed dose and the benefit of talking about what got in the way of taking missed doses, emphasize better late than never 4. Identify what to do if the person misses a dose: 5. Identify what is considered a missed dose and what to do: a. If a person forgets to take a dose and remembers up to 12 hours after usual med time they should still take the missed med and take the next dose at the usual time b. Person should not take a double dose to make up for a missed dose Common side effects 1. Headache, upset stomach, vomiting, loss of appetite 2. These usually improve or resolve within a few weeks. Long-term safety of 1. 2 year follow up in clinical studies suggest Truvada is safe when used for in persons without HIV infection. Baseline tests and ongoing schedule for monitoring 1. Explain that person will need to be seen in clinic when the medication is started, one month and 3 months after starting the. After that point, person will need to be seen in clinic every 3 months while taking (see schedule below) Criteria for stopping Risk-reduction education and the use of condoms Symptoms of acute HIV infection. 1. If a person taking has a positive HIV test they need to stop to prevent drug resistance. They will need to see an HIV specialist to begin treatment for HIV. 2. Other reasons for stopping Truvada include intolerable toxicities, renal disease, nonadherence to medication or appointments, or a change in risk behaviors and is no longer needed. 3. If a person wants to restart after stopping it they should undergo the same evaluation as a person being newly prescribed. 1. Discuss risk-reduction activities that apply to each person s individual situation. 2. Have a nonjudgmental conversation about safer sex with person. Provide a safe space to discuss condom use. Provide condoms when person would like them. 3. For persons using injection drugs refer to needle-exchange programs 4. For persons in relationship with partners with HIV infection, encourage person with HIV to participate in care and take treatment for HIV. 1. Acute HIV infection is the name given to the time just after a person first acquires HIV infection. People with acute HIV infection may have the following symptoms: fever, rash, mouth sores, fatigue, night sweats, sore throat, muscle and joint aches, diarrhea, swollen tonsils and lymph nodes. Acute HIV infection may be asymptomatic. Page 3 of 5
For Women: Potential Benefits/Risks if Pregnancy Occurs During Use of 2. The symptoms can begin a few days after a person is exposed to HIV. They usually last on average, about 2 weeks. 3. Persons taking with these symptoms should call their provider immediately to obtain HIV testing. 1. If a woman becomes pregnant while taking it is an individualized decision based on the person s current risks for HIV infection. 2. Benefits: prevent acute HIV infection during pregnancy which is a significant risk factor for mother to child HIV transmission 3. Potential toxicity: Available data suggest that Truvada does not increase risk of birth defects, however there are not enough data to exclude the possibility of harm STEP 4: Draw Baseline Labs and Wait for Results Before Starting 1. 4 th generation HIV test 2. HIV RNA PCR only if they have had sex in the last 14 days 3. Creatinine 4. Urinalysis 5. Serology for Hepatitis A, B & C with appropriate Hep A & B immunization follow-up 6. Check HPV vaccinations start or continue vaccinations if necessary. 7. Screen for STIs including GC, Chlamydia, and syphilis. Screening for GC and Chlamydia should include as appropriate, genital, rectal, and pharyngeal testing. 8. Pregnancy test STEP 5: Prescribing 1. Only prescribe after the person s baseline laboratory results return. The HIV antibody/antigen screen AND the HIV RNA PCR must return as negative to start. 2. Recommended Regimen: Truvada, 1 tablet daily 3. Truvada is a fixed-dose tablet with 300 mg Tenofovir + emtricitabine 200 mg. Page 4 of 5
STEP 6: Ongoing Clinical and Laboratory Monitoring Clinical and Laboratory Monitoring Pre- Prescription Visit Visit to Prescribe 1 month after starting 3 months after starting Education about Readiness to take Discuss adherence to Assess for symptoms of primary HIV infection Discuss person s experience with including side effects, adherence, and interest in continuing. Provide risk-reduction counseling including condoms Every 3 months Every 6 months (with 3 months) HIV Antigen/Antibody test Creatinine Urinalysis (check for protein) Hepatitis A & B screening STI screening (syphilis, GC, Chlamydia) oral, anal, vaginal testing Every Year (with 3 months) Pregnancy test (females) Hepatitis C Clinic Visit Clinic visits and medication refills are based Script for 30 day supply on person s specific situation and provider knowledge of the person. Labwork can be done independent of clinic visits. Special Considerations: If patient is a minor < 18 years of age: 1. Truvada is FDA approved for use at adult doses in persons age 12 years and older AND weighs at least 35 kg. 2. Wisconsin State law allows for persons aged 14 years and older to consent for STI testing and treatment without parental consent. 3. Wisconsin requires consent from parent/legal guardian before starting. 4. The safety evidence available for the use of Truvada in youth with HIV infection indicate the possibility of bone and renal toxicities among youth who are still growing. The risks of these potential toxicities should be weighed against the potential benefit of reducing the risk of HIV infection Page 5 of 5