Recommendations for use of the recently approved NNRTI rilpivirine have been added to the U.S. Department of Health and Human Services adult and adolescent ART guidelines. The guidelines designate rilpivirine in combination with either tenofovir/emtricitabine or abacavir/lamivudine as "alternative" regimens for initial therapy, and they include rilpivirine with zidovudine/lamivudine as an "acceptable" regimen. They note that rilpivirine should be used with caution for persons with pretreatment HIV RNA levels of >100,000 copies/mL, as elevated rates of virologic failure were reported among subjects with high viral loads in Phase 3 studies.
Rilpivirine is available as a free-standing agent and as a component in a fixed-dose combination with tenofovir/emtricitabine (Complera). Rilpivirine must be taken with food. Additionally, it requires gastric acid for absorption and cannot be given with proton-pump inhibitors (dosing of other acid-lowering medications requires specific timing).
The package insert for raltegravir (Isentress) has been amended to include warnings about the possibility of severe rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis, as well as hypersensitivity reactions. Persons taking raltegravir who experience rash or symptoms of hypersensitivity should be evaluated promptly, and raltegravir should be discontinued if it is thought to be a contributing factor.
Darunavir Oral Suspension
An oral suspension formulation of darunavir (100 mg/mL) has been approved by the U.S. Food and Drug Administration. It is intended for children and adults who are unable to swallow pills, and the pediatric indication now includes children >3 years of age. Dosage recommendations for children 3-6 years of age are forthcoming. Darunavir must be taken with ritonavir (eg, ritonavir solution).