for Health Care Providers
HIV Meds Quarterly
Research Briefs: Recent Advances in Once-Daily Therapies and Fixed-Dose Combination Regimens
Rilpivirine (TMC278) in Initial Therapy
S/GSK 572 in Initial Therapy: Interim Results of SPRING-1
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (Quad Pill) in Initial Therapy
Novel Pharmacokinetic Booster Cobicistat (GS-9350)
Maraviroc in patients with kidney disease
Labeling changes have been made to guide use of maraviroc in patients with renal impairment.
Dosage adjustment for patients with mild or moderate chronic kidney disease (CrCl ≤80 mL/min but ≥30 mL/min) does not appear necessary. In patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease (ESRD) who are taking a potent CYP3A inhibitor or inducer, maraviroc should not be used. In patients with severe renal impairment or ESRD who are not on CYP3A inhibitors or inducers, the manufacturer advises that maraviroc should be used only if other ARV options are not available. Additionally, there appears to be heightened risk of postural hypotension in patients with severe renal impairment or ESRD who take maraviroc. If patients with severe renal impairment or ESRD who take maraviroc experience symptoms of postural hypotension, the dosage of maraviroc should be reduced to 150 mg BID.
more on maraviroc
Selzentry [prescribing information]. New York: Pfizer Labs. May 2010.
McNicholl I, Rodriguez R. Dosing of Antiretroviral Drugs in Adults with Chronic Kidney Disease and Hemodialysis. In: HIV InSite, Coffey S, Volberding P, eds. San Francisco: UCSF Center for HIV Information; updated regularly.
Didanosine and noncirrhotic portal hypertension
The U.S. Food and Drug Administration (FDA) announced that postmarketing surveillance has revealed a small number of cases of noncirrhotic portal hypertension in patients receiving didanosine (Videx and Videx EC). Forty-two cases have been identified, in both men and women, in both children and adults, and in patients with various durations of didanosine treatment (months to years). Complications have included variceal bleeding, liver failure, and death. Alternative causes of portal hypertension in these patients (eg, cirrhosis related to alcohol use or viral hepatitis) were excluded. The FDA warns that patients taking didanosine should be advised of the possible risk of noncirrhotic portal hypertension and that patients should be monitored (by history, physical examination, and laboratory evaluation) for early signs of portal hypertension. The Videx and Videx EC package labels now include this information.
more on didanosine
Videx [prescribing information]. Princeton, NJ: Bristol Myers Squibb. January 2010.