In virologically-suppressed tenofovir DF-treated patients who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide or who remained on initial regimen, mean BMD increased between baseline and 96 weeks in those who switched and decreased slightly in those on initial regimen; decreased BMD was also reported in patients who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide.Elevated creatine kinase, rhabdomyolysis, muscular weakness, osteomalacia (manifested as bone pain and infrequently contributing to fractures), and myopathy were reported in clinical trials or during postmarketing experience for emtricitabine or tenofovir DF with other antiretrovirals.Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy have occurred as a result of proximal renal tubulopathy.Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:-Very common (10% or more): Decreased bone mineral density (BMD), elevated creatine kinase-Uncommon (0.1% to 1%): Fractures (excluding fingers and toes)-Frequency not reported: Increased biochemical markers of bone metabolism, increased BMDCobicistat/elvitegravir/emtricitabine/tenofovir DF:-Very common (10% or more): Elevated creatine kinase-Very common (10% or more): Elevated creatine kinase-Common (1% to 10%): Arthralgia, myalgia, back pain-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness-Rare (less than 0.1%): Osteomalacia (manifested as bone pain and infrequently contributing to fractures), myopathy-Frequency not reported: Decreased BMD, increased biochemical markers of bone metabolism-Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathyCobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:Cobicistat/elvitegravir/emtricitabine/tenofovir DF:-Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis, neuropathy)Altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL) has been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.Hypophosphatemia, hyperglycemia, hypertriglyceridemia, Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.Hypokalemia and hypophosphatemia have occurred as a result of proximal renal tubulopathy.Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:Cobicistat/elvitegravir/emtricitabine/tenofovir DF:-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia-Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia-Frequency not reported: Redistribution/accumulation of body fat (including central During trials in therapy-naive patients, increases from baseline for the fasting lipid parameters (total cholesterol, direct LDL cholesterol, and HDL cholesterol) were observed with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat/elvitegravir/emtricitabine/tenofovir DF at 144 weeks of therapy; such increases were greater with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide.Elevated fasting LDL cholesterol (greater than 190 mg/dL) and elevated fasting total cholesterol (greater than 300 mg/dL) have been reported in up to 11% and up to 4%, respectively, of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and up to 5% and up to 3%, respectively, of patients using cobicistat/elvitegravir/emtricitabine/tenofovir DF.In clinical trials, the following mean increases in fasting lipid values were reported after 144 weeks of therapy: total cholesterol increased by 31 mg/dL, LDL cholesterol by 20 mg/dL, HDL cholesterol by 7 mg/dL, and triglycerides by 29 mg/dL with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and total cholesterol increased by 14 mg/dL, LDL cholesterol by 8 mg/dL, HDL cholesterol by 3 mg/dL, and triglycerides by 17 mg/dL with cobicistat/elvitegravir/emtricitabine/tenofovir DF.Elevated alkaline phosphatase (greater than 550 units/L), elevated fasting cholesterol (greater than 240 mg/dL), and elevated fasting triglycerides (greater than 750 mg/dL) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials. 2008 Mar;35(3):472-6. If you have a regular sexual partner, your doctor may ask to talk to the two of you together. The next most common cause is beta blockers. In: Sidawy AN, Perler BA, eds. Genvoya can cause serious, life-threatening side effects. This drug was permanently discontinued in 5 patients who developed renal side effects through 96 weeks; 3 of the 5 patients were among the 80 patients with baseline estimated CrCl less than 50 mL/min and 2 patients were among the 162 subjects with baseline estimated CrCl at least 50 mL/min. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. 2002 Nov-Dec;20(6 Suppl 28):S76-80.Leenhardt R, Rivière P, Papazian P, Nion-Larmurier I, Girard G, Laharie D, Marteau P.World J Gastroenterol. Elevated ALT (greater than 3 x ULN) has been reported in up to 2% of patients using cobicistat/elvitegravir/emtricitabine/tenofovir DF.Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 after discontinuation of emtricitabine or tenofovir DF and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.Elevated ALT (greater than 215 units/L in males and 170 units/L in females) and elevated bilirubin (greater than 2.5 x ULN) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.Increased transaminases, hyperbilirubinemia, hepatic steatosis, and hepatitis were reported in clinical trials or during postmarketing experience for emtricitabine or tenofovir DF with other antiretrovirals.Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:Cobicistat/elvitegravir/emtricitabine/tenofovir DF:-Common (1% to 10%): Upper respiratory tract infection, bronchitis-Common (1% to 10%): Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, rhinitisNasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, and rhinitis have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.Cobicistat/elvitegravir/emtricitabine/tenofovir DF:Cobicistat/elvitegravir/emtricitabine/tenofovir DF:-Frequency not reported: Immune reconstitution/reactivation syndrome, -Postmarketing reports: Immune reconstitution syndrome-Postmarketing reports: Immune reconstitution syndromeDecreased neutrophils (less than 750/mm3) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.Anemia was common in pediatric patients using emtricitabine.Allergic reaction was reported in clinical trials or during postmarketing experience for emtricitabine or tenofovir DF with other antiretrovirals.-Postmarketing reports: Allergic reaction (including angioedema)-Frequency not reported: Higher serum parathyroid hormone levels1.
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