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RPV+ABC/3TC

Overview

RPV + ABC/3TC is a dual NRTI regimen in combination with an NNRTI. This regimen is recommended by both the DHHS and the IAS in treatment-naïve patients and are recommended for consideration for treatment-experienced patients. NNRTI-based regimens are most commonly recommended for patients who require an INSTI-sparing regimen. This regimen should only be administered to patients who are HLA-B*5701 negative.

Recommendations for Treatment-Naïve Patients

DHHS: This regimen is not explicitly discussed by the DHHS. However, a recommended initial ARV regimen for a treatment-naïve patient contains 2 NRTIs (i.e. ABC/3TC) and 1 drug from another drug class (i.e. 1 NNRTI). 2 NRTI + 1 NNRTI regimens are recommended as alternative regimens by the DHHS for treatment-naïve patients with an HIV RNA <100,000 copies/mL and a CD4 count of > 200 cells/mm3. These regimens have been found to be effective and tolerable, but have potential disadvantages, limitations for use, and/or less supporting data from RCT than recommended regimens. However, it is important to note that this type of regimen may be the preferred regimen for some patients, particularly those who are HLA-B*5701 negative.

IAS: This regimen is not discussed in the IAS guidelines. However, a regimen of 2 NRTIs + 1 NNRTI is a recommended initial regimen for individuals in whom an INSTI is not an option. RPV-containing regimens have low risk of rash and are the smallest single-pill regimens available, but have limitations in pts with high Vl or low CD4.

Recommendations for Treatment-Experienced Patients

DHHS: This regimen is not discussed for treatment-experienced patients in the guidelines. In virally suppressed patients, a switch to this type of regimen (2 NRTIs + 1 NNRTI) is only recommended in cases where a switch would maintain viral suppression and where there is no resistance to any components in the regimen. In certain circumstances, a boosted PI can be replaced with RPV. Within the NNRTI class, switching from EFV to RPV is recommended if there is either an adverse event or because RPV offers a better safety profile, reduced dosing frequency, and lower pill burden, as long as viral suppression is maintained and there is no drug resistance to RPV. In cases of confirmed virologic failure, the DHHS does not currently recommend switching to an NNRTI-based regimen at this time.

IAS: There is no explicit recommendation to switch to this regimen in the IAS guidelines. Situations in which patients should be recommended a switch include use of old NRTIs as they have long-term toxic effects, or older drugs that have higher pill burdens and are more metabolically toxic.

Other Considerations 

ABC

  • May see hypersensitivity reaction in patients who are not HLA-B*5701 negative

RPV

  • Smallest tablet among the single-pill regimens
  • Approved for use in patients with pre-treatment viral loads <100,000 copies/mL and CD4 count >200 cells/mm3
  • Must be taken with a high-calorie meal (at least 390 kcal)
  • Interacts with many other drugs
  • Contraindicated with PPIs, use with caution with H2 antagonists or antacids
  • Can prolong the QTc
  • Lowest risk of rash among NNRTI-based therapies, and low risk of metabolic adverse effects
  • Possible side effects include depressive disorders and suicidality

 

Efficacy in Clinical Trials

Trial Name

Drugs Compared

Participants

Study Results

ECHO and THRIVE

2 NRTIs plus RPV or EFV

1368 tx-naive

At week 48 the RPV arm was noninferior to the EFV arm (overall 84% viral suppression versus 82%).  Virologic failure occurred in 9% of patients in the RPV arm and 5% in the EFV arm. Discontinuation due to adverse events occurred in 3% of the RPV arm and 8% of the EFV arm. In participants with virologic failure, NNRTI and NRTI resistance was more frequently identified in the RPV arm. Also, in the RPV arm the rate of virologic failure was greater in those with pre-treatment CD4 counts <200 cells/mm3. These findings held at 96 weeks (overall viral suppression of 77% in both arms; viral suppression of 83% and 80% for persons with baseline HIV RNA <100,000 copies/mL; viral suppression of 60% versus 75% in persons with baseline HIV RNA levels of >500,000 copies/mL; 4% discontinuation due to adverse events in the RPV arm and 8% in the EFV arm; NNRTI and NRTI resistance was more frequently identified in the RPV arm in persons with virologic failure). [1] [2] [3] . 


References

  1. Citekey 156 not found
  2. Citekey 186 not found
  3. Citekey 185 not found