PrEP REGIMENS AND SIDE EFFECTS PrEP Regimens PrEP Side Effects: Reports from RCTs In clinical trials, approximately 10% of participants experienced side effects. The side effects were mild and short-term, and did not persist beyond the first month. Side effects may include: Gastrointestinal (GI) side effects (nausea/vomiting/abdominal pain). Creatinine elevation (typically reversible). Loss of bone mineral density; recovers after stopping PrEP. Side Effects Reported from iPrEx Open-label Extension (iPrEx OLE): Observational Study iPrEx OLE multi-site PrEP cohort taking daily oral TDF/FTC: 39% of participants reported any PrEP-related (mainly mild) side effects. A “start-up syndrome” has been reported: GI symptoms (nausea, flatulence, diarrhea, abdominal pain, vomiting), headaches, skin problems/itching. The “start-up syndrome” is transient but can influence adherence: Side effects among PrEP users peaked around month one and symptoms are resolved by month three. Adherence counseling should focus on the transient nature of a “start-up syndrome”. RISK BEHAVIORS, HIVDR, AND STIs Will PrEP encourage people to use condoms less often or to have more sexual partners – i.e. “risk compensation”? There was no evidence of this in clinical trials. The PROUD study showed that for participants who were at high risk before initiating PrEP, sexual behavior remained unchanged whether or not participants received PrEP. Will PrEP lead to more HIV drug resistance (HIVDR)? HIVDR in PrEP users was rare in clinical trials. HIVDR occurred mostly in cases where the person had undiagnosed HIV infection at the time of starting PrEP.
PrEP REGIMENS AND SIDE EFFECTS PrEP Regimens PrEP Side Effects: Reports from RCTs In clinical trials, approximately 10% of participants experienced side effects. The side effects were mild and short-term, and did not persist beyond the first month. Side effects may include: Gastrointestinal (GI) side effects (nausea/vomiting/abdominal pain). Creatinine elevation (typically reversible). Loss of bone mineral density; recovers after stopping PrEP. Side Effects Reported from iPrEx Open-label Extension (iPrEx OLE): Observational Study iPrEx OLE multi-site PrEP cohort taking daily oral TDF/FTC: 39% of participants reported any PrEP-related (mainly mild) side effects. A “start-up syndrome” has been reported: GI symptoms (nausea, flatulence, diarrhea, abdominal pain, vomiting), headaches, skin problems/itching. The “start-up syndrome” is transient but can influence adherence: Side effects among PrEP users peaked around month one and symptoms are resolved by month three. Adherence counseling should focus on the transient nature of a “start-up syndrome”. RISK BEHAVIORS, HIVDR, AND STIs Will PrEP encourage people to use condoms less often or to have more sexual partners – i.e. “risk compensation”? There was no evidence of this in clinical trials. The PROUD study showed that for participants who were at high risk before initiating PrEP, sexual behavior remained unchanged whether or not participants received PrEP. Will PrEP lead to more HIV drug resistance (HIVDR)? HIVDR in PrEP users was rare in clinical trials. HIVDR occurred mostly in cases where the person had undiagnosed HIV infection at the time of starting PrEP.