The Medical Letter ® on Drugs and Therapeutics Volume 58 ISSUE ISSUE No 1433 1488 Volume 56 February 15, 2016 IN THIS ISSUE Genvoya — A New 4-Drug Combination for HIV p 19 Selexipag (Uptravi) for Pulmonary Arterial Hypertension p 21 Patiromer (Veltassa) for Hyperkalemia p 23 Correction: Drugs for Acne p 24 Important Copyright Message FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS The Medical Letter, Inc publications are protected by U.S and international copyright laws Forwarding, copying or any distribution of this material is prohibited Sharing a password with a non-subscriber or otherwise making the contents of this site available to third parties is strictly prohibited By accessing and reading the attached content I agree to comply with U.S and international copyright laws and these terms and conditions of The Medical Letter, Inc For further information click: Subscriptions, Site Licenses, Reprints or call customer service at: 800-211-2769 Published by The Medical Letter, Inc • A Nonprofit Organization The Medical Letter publications are protected by US and international copyright laws Forwarding, copying or any other distribution of this material is strictly prohibited For further information call: 800-211-2769 The Medical Letter ® on Drugs and Therapeutics Volume 58 ISSUE ISSUE No 1433 1488 Volume 56 ▶ February 15, 2016 ALSO IN THIS ISSUE Selexipag (Uptravi) for Pulmonary Arterial Hypertension p 21 Patiromer (Veltassa) for Hyperkalemia p 23 Correction: Drugs for Acne p 24 Genvoya — A New 4-Drug Combination for HIV Table Recommended Regimens for Treatment of HIV-1 Infection in Antiretroviral-Naive Patients1 PI-Based Regimen Darunavir + ritonavir (once daily) + TDF/emtricitabine2 The FDA has approved Genvoya (Gilead), a fixeddose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for treatment of HIV1 infection in patients ≥12 years old This is the first approval for tenofovir alafenamide (TAF), a tenofovir prodrug Stribild, a fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (TDF), was approved in 2012.1 Pronunciation Key Genvoya: jen voy' uh Elvitegravir : el'' vi teg' veer Cobicistat: koe bik' i stat Emtricitabine: em'' trye sye' ta been Tenofovir alafenamide: ten of' oh veer al'' a fen' a mide STANDARD TREATMENT – Recently updated guidelines recommend that antiretroviral-naive patients infected with HIV-1 receive an INSTIbased regimen or a regimen including the protease inhibitor (PI) darunavir boosted with ritonavir (see Table 1) Because the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the PI atazanavir have been associated with higher rates of toxicity, combinations including these drugs are now considered alternative rather than recommended treatment options.2,3 TENOFOVIR ALAFENAMIDE — Systemic exposure to tenofovir can cause nephrotoxicity and a decrease in bone mineral density (BMD).4 Unlike TDF, which is extensively converted to tenofovir in plasma, TAF activation occurs predominantly intracellularly In a pharmacokinetic analysis, TAF 10 mg once daily produced circulating tenofovir levels that were 91% INSTI-Based Regimens Dolutegravir + either abacavir3/lamivudine2 or TDF/emtricitabine2 Elvitegravir/cobicistat/TAF/emtricitabine4 Elvitegravir/cobicistat/TDF/emtricitabine5 Raltegravir + TDF/emtricitabine2 TDF = tenofovir disoproxil fumarate; TAF = tenofovir alafenamide For non-pregnant adults and adolescents Adapted from DHHS guidelines Available at: aidsinfo.nih.gov/guidelines Emtricitabine can be substituted for lamivudine, and vice versa For patients who test negative for HLA-B*5701 Abacavir should be used with caution in patients with a pretreatment viral load >100,000 copies/mL and in those who are at high risk for cardiovascular disease Not recommended for use in patients with CrCl 5.5 mEq/L is 16.8 g once daily b The prepared suspension should only be consumed if it is transparent c Twice-daily dosing of patiromer is recommended in patients with an eGFR