GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(六)
subjects with a baseline eGFR between 30 and 50 mL per minute and two of 162 (1%) with a baseline eGFR greater than or equal to 50 mL per minute [see ADVERSE REACTIONS (6.1)]. GENVOYA is not recommended in patients with estimated creatinine clearance below 30 mL per minute.
Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including non-steroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.
It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose and urine protein be assessed before initiating GENVOYA and during therapy in all patients as clinically appropriate. Discontinue GENVOYA in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Cobicistat, a component of GENVOYA, produces elevations of serum creatinine due to inhibition of tubular secretion of creatinine without affecting glomerular filtration [see ADVERSE REACTIONS (6.1)]. The elevation is typically seen within 2 weeks of starting therapy and is reversible after discontinuation. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg per dL from baseline should be closely monitored for renal safety.
5.5 Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of GENVOYA, and tenofovir DF, another prodrug of tenofovir, alone or in combination with other antiretrovirals. Treatment with GENVOYA should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
6 ADVERSE REACTIONS
The following adverse drug reactions are discussed in other sections of the labeling:
Severe Acute Exacerbations of Hepatitis B [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)]
Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS (5.3)]
New Onset or Worsening Renal Impairment [see WARNINGS AND PRECAUTIONS (5.4)]
Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS (5.5)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials in Treatment-Naïve Adults
The primary safety assessment of GENVOYA was based on Week 96 pooled data from 1,733 subjects in two randomized, double-blind, active-controlled trials, Study 104 and Study 111, in antiretroviral treatment-naïve HIV-1 infected adult subjects. A total of 866 subjects received one tablet of GENVOYA once daily [see CLINICAL STUDIES (14.2)].
The most common adverse reaction (all Grades) reported in at least 10% of subjects in the GENVOYA group was nausea. The proportion of subjects who discontinued treatment with GENVOYA or STRIBILD® due to adverse events, regardless of severity, was 1% and 2%, respectively. Table 2 displays the frequency of adverse reactions (all Grades) greater than or equal to 5% in the GENVOYA group.
Table 2 Adverse Re |
