FDA label 4d9620da-767c-4e13-ac6e-2c3ec0ecdbcf

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )

5 WARNINGS AND PRECAUTIONS Risk of adverse reactions or loss of virologic response due to drug interactions: The concomitant use of GENVOYA and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of GENVOYA and possible development of resistance; and possible clinically significant adverse reactions from greater exposures of concomitant drugs. ( 5.2 ) Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.3 ) New onset or worsening renal impairment: Prior to and during therapy, as clinically appropriate, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients, and also assess serum phosphorus in patients with chronic kidney disease . ( 5.4 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.5 ) 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV Patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) before initiating antiretroviral therapy [see Dosage and Administration (2.1) ] . GENVOYA is not approved for the treatment of chronic HBV infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Patients coinfected with HIV-1 and HBV who discontinue GENVOYA should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. 5.2 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of GENVOYA and other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Contraindications (4) and Drug Interactions (7.5) ]: Loss of therapeutic effect of GENVOYA and possible development of resistance. Possible clinically significant adverse reactions from greater exposures of concomitant drugs. See Table 6 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during GENVOYA therapy; review concomitant medications during GENVOYA therapy; and monitor for the adverse reactions associated with the concomitant drugs. 5.3 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including emtricitabine, a component of GENVOYA. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment. 5.4 New Onset or Worsening Renal Impairment Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials. In clinical trials of GENVOYA, there have been no cases of Fanconi syndrome or Proximal Renal Tubulopathy (PRT). In clinical trials of GENVOYA in treatment-naïve subjects and in virologically suppressed subjects switched to GENVOYA with eGFRs greater than 50 mL per minute, renal serious adverse events or discontinuations due to renal adverse reactions were encountered in less than 1% of participants treated with GENVOYA. In a study of virologically suppressed subjects with baseline eGFRs between 30 and 69 mL per minute treated with GENVOYA for a median duration of 144 weeks, GENVOYA was permanently discontinued due to worsening renal function in three of 80 (4%) 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. Prior to and during treatment, as clinically appropriate, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients, and also assess serum phosphorus in patients with chronic kidney disease. 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) ] Most common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 144 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 Reactions Frequencies of adverse reactions are based on all adverse events attributed to study drugs by the investigator. (All Grades) Reported in ≥ 5% of HIV-1 Infected Treatment-Naïve Adults Receiving GENVOYA in Studies 104 and 111 (Week 144 analysis) GENVOYA N=866 STRIBILD N=867 Nausea 11% 13% Diarrhea 7% 9% Headache 6% 5% Fatigue 5% 4% The majority of events presented in Table 2 occurred at severity Grade 1. Clinical Trials in Virologically Suppressed Adults The safety of GENVOYA in virologically-suppressed adults was based on Week 96 data from 959 subjects in a randomized, open-label, active-controlled trial (Study 109) in which virologically-suppressed subjects were switched from a TDF-containing combination regimen to GENVOYA. Overall, the safety profile of GENVOYA in subjects in this study was similar to that of treatment-naïve subjects [see Clinical Studies (14.3) ] . Additional adverse reactions observed with GENVOYA in Study 109 included suicidal ideation, suicidal behavior, and suicide attempt (<1% combined); all of these events were serious and all occurred in subjects with a preexisting history of depression or psychiatric illness. Clinical Trials in Adult Subjects with Renal Impairment In an open-label trial (Study 112), 248 HIV-1 infected subjects with eGFR of 30 to 69 mL per minute (by Cockcroft-Gault method) were treated with GENVOYA for a median duration of 144 weeks. Of these subjects, 65% had previously been on a stable TDF-containing regimen. A total of 5 subjects permanently discontinued GENVOYA due to the development of renal adverse events through Week 96. Three of these five were among the 80 subjects with baseline eGFRs of < 50mL/min and two subjects were among the 162 subjects with baseline eGFRs of ≥ 50mL/min. There were no further renal discontinuations between Weeks 96 and 144. Overall, renally impaired subjects receiving GENVOYA in this study had a mean serum creatinine of 1.5 mg/dL at baseline and 1.4 mg/dL at Week 144. Otherwise, the safety profile of GENVOYA in subjects in this study was similar to that of subjects with normal renal function [see Clinical Studies (14.4) ] . Renal Laboratory Tests and Renal Safety Treatment-Naïve Adults: Cobicistat (a component of GENVOYA) has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting glomerular filtration [see Clinical Pharmacology (12.2) ] . Increases in serum creatinine occurred by Week 2 of treatment and remained stable through 144 weeks. In two 144-week randomized, controlled trials in a total of 1,733 treatment-naïve adults with a median baseline eGFR of 115 mL per minute, mean serum creatinine increased by less than 0.1 mg per dL in the GENVOYA group and by 0.1 mg per dL in the STRIBILD group from baseline to Week 144. Virologically Suppressed Adults: In a study of 1,436 virologically-suppressed TDF-treated adults with a mean baseline eGFR of 112 mL per minute who were randomized to continue their treatment regimen or switch to GENVOYA, at Week 96 mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to GENVOYA. Bone Mineral Density Effects Treatment-Naïve Adults: In a pooled analysis of Studies 104 and 111, the effects of GENVOYA compared to STRIBILD on bone mineral density (BMD) change from baseline to Week 144 were assessed by dual-energy X-ray absorptiometry (DXA). The mean percentage change in BMD from baseline to Week 144 was −0.92% with GENVOYA compared to −2.95% with STRIBILD at the lumbar spine and −0.75% compared to −3.36% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 15% of GENVOYA subjects and 29% of STRIBILD subjects. BMD declines of 7% or greater at the femoral neck were experienced by 15% of GENVOYA subjects and 29% of STRIBILD subjects. The long-term clinical significance of these BMD changes is not known. Virologically Suppressed Adults: In Study 109, TDF-treated subjects were randomized to continue their TDF-based regimen or switch to GENVOYA; changes in BMD from baseline to Week 96 were assessed by DXA. Mean BMD increased in subjects who switched to GENVOYA (2.12% lumbar spine, 2.44% total hip) and decreased slightly in subjects who continued their baseline regimen (−0.09% lumbar spine, −0.46% total hip). BMD declines of 5% or greater at the lumbar spine were experienced by 2% of GENVOYA subjects and 6% of subjects who continued their TDF-based regimen. BMD declines of 7% or greater at the femoral neck were experienced by 2% of GENVOYA subjects and 7% of subjects who continued their TDF-based regimen. The long-term clinical significance of these BMD changes is not known. Laboratory Abnormalities: The frequency of laboratory abnormalities (Grades 3–4) occurring in at least 2% of subjects receiving GENVOYA in Studies 104 and 111 are presented in Table 3. Table 3 Laboratory Abnormalities (Grades 3–4) Reported in ≥ 2% of Subjects Receiving GENVOYA in Studies 104 and 111 (Week 144 analysis) Laboratory Parameter Abnormality Frequencies are based on treatment-emergent laboratory abnormalities. GENVOYA N=866 STRIBILD N=867 Creatine Kinase (≥10.0 × ULN) 11% 10% LDL-cholesterol (fasted) (>190 mg/dL) 11% 5% Total cholesterol (fasted) (>300mg/dL) 4% 3% Amylase 3% 5% ALT 3% 3% AST 3% 4% Urine RBC (Hematuria) (>75 RBC/HPF) 3% 3% Serum Lipids: Subjects receiving GENVOYA experienced greater increases in serum lipids compared to those receiving STRIBILD. Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol to HDL ratio are presented in Table 4. Table 4 Lipid Values, Mean Change from Baseline, Reported in Subjects Receiving GENVOYA or STRIBILD in Studies 104 and 111 Excludes subjects who received lipid lowering agents during the treatment period. GENVOYA N=866 STRIBILD N=867 Baseline Week 144 Baseline Week 144 mg/dL Change The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 144 values. mg/dL Change Total Cholesterol (fasted) 162 [N=647] +31 [N=647] 165 [N=627] +14 [N=627] Triglycerides (fasted) 111 [N=647] +29 [N=647] 115 [N=627] +17 [N=627] LDL-cholesterol (fasted) 103 [N=647] +20 [N=643] 107 [N=628] +8 [N=628] HDL-cholesterol (fasted) 47 [N=647] +7 [N=647] 46 [N=627] +3 [N=627] Total Cholesterol to HDL ratio 3.7 [N=647] 0.2 [N=647] 3.8 [N=627] 0.1 [N=627] Clinical Trials in Pediatric Subjects: Safety in Pediatric Patients The safety of GENVOYA in HIV-1 infected pediatric subjects was evaluated in treatment-naïve subjects between the ages of 12 to less than 18 years and weighing at least 35 kg (N=50) through Week 48 (cohort 1), and in virologically-suppressed subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (N=23) through Week 24 (cohort 2) in an open-label clinical trial (Study 106) [see Clinical Studies (14.5) ] . With the exception of a decrease in the mean CD4+ cell count observed in cohort 2 of Study 106, the safety profile in pediatric subjects who received treatment with GENVOYA was similar to that in adults. One 13-year-old female subject developed unexplained uveitis while receiving GENVOYA that resolved and did not require discontinuation of GENVOYA. Bone Mineral Density Effects Cohort 1: Treatment-naïve adolescents (12 to less than 18 years; at least 35 kg) Among the subjects in cohort 1 receiving GENVOYA, mean BMD increased from baseline to Week 48, + 4.2% at the lumbar spine and + 1.3% for the total body less head (TBLH). Mean changes from baseline BMD Z-scores were −0.07 for lumbar spine and −0.20 for TBLH at Week 48. One GENVOYA subject had significant (at least 4%) lumbar spine BMD loss at Week 48. Cohort 2: Virologically-suppressed children (6 to less than 12 years; at least 25 kg) Among the subjects in cohort 2 receiving GENVOYA, mean BMD increased from baseline to Week 24, +2.9% at the lumbar spine and +1.7% for TBLH. Mean changes from baseline BMD Z-scores were -0.06 for lumbar spine and -0.18 for TBLH at Week 24. Two GENVOYA subjects had significant (at least 4%) lumbar spine BMD loss at Week 24. Change from Baseline in CD4+ cell counts Cohort 2: Virologically-suppressed children (6 to less than 12 years; at least 25 kg) Cohort 2 of Study 106 evaluated pediatric subjects (N=23) who were virologically-suppressed and who switched from their antiretroviral regimen to GENVOYA. Although all subjects had HIV-1 RNA < 50 copies/mL, there was a decrease from baseline in CD4+ cell count at Week 24. The mean baseline and mean change from baseline in CD4+ cell count and in CD4% from Week 2 to Week 24 are presented in Table 5. All subjects maintained their CD4+ cell counts above 400 cells/mm 3 [see Pediatric Use (8.4) and Clinical Studies (14.5) ]. Table 5 Mean Change in CD4+ Count and Percentage from Baseline to Week 24 in Virologically-Suppressed Pediatric Patients from 6 to <12 Years Who Switched to GENVOYA Baseline Mean Change from Baseline Week 2 Week 4 Week 12 Week 24 CD4+ Cell Count (cells/mm 3 ) 966 (201.7) Mean (SD) -162 -125 -162 -150 CD4% 40 (5.3) +0.5% -0.1% -0.8% -1.5%

<table width="75%"> <caption>Table 2 Adverse Reactions<footnote>Frequencies of adverse reactions are based on all adverse events attributed to study drugs by the investigator.</footnote> (All Grades) Reported in &#x2265; 5% of HIV-1 Infected Treatment-Na&#xEF;ve Adults Receiving GENVOYA in Studies 104 and 111 (Week 144 analysis)</caption> <col align="left" valign="top" width="60%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <thead> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">GENVOYA N=866</th> <th styleCode="Rrule">STRIBILD N=867</th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Nausea</td> <td styleCode="Rrule">11%</td> <td styleCode="Rrule">13%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Diarrhea</td> <td styleCode="Rrule">7%</td> <td styleCode="Rrule">9%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Headache</td> <td styleCode="Rrule">6%</td> <td styleCode="Rrule">5%</td> </tr> <tr> <td styleCode="Lrule Rrule">Fatigue</td> <td styleCode="Rrule">5%</td> <td styleCode="Rrule">4%</td> </tr> </tbody> </table>

<table width="60%"> <caption>Table 3 Laboratory Abnormalities (Grades 3&#x2013;4) Reported in &#x2265; 2% of Subjects Receiving GENVOYA in Studies 104 and 111 (Week 144 analysis)</caption> <col align="left" valign="bottom" width="50%"/> <col align="center" valign="bottom" width="25%"/> <col align="center" valign="bottom" width="25%"/> <thead> <tr> <th styleCode="Lrule Rrule">Laboratory Parameter Abnormality<footnote>Frequencies are based on treatment-emergent laboratory abnormalities.</footnote> </th> <th styleCode="Rrule">GENVOYA N=866</th> <th styleCode="Rrule">STRIBILD N=867</th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Creatine Kinase (&#x2265;10.0 &#xD7; ULN)</td> <td styleCode="Rrule">11%</td> <td styleCode="Rrule">10%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">LDL-cholesterol (fasted) (&gt;190 mg/dL)</td> <td styleCode="Rrule">11%</td> <td styleCode="Rrule">5%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Total cholesterol (fasted) (&gt;300mg/dL)</td> <td styleCode="Rrule">4%</td> <td styleCode="Rrule">3%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Amylase</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">5%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">ALT</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">3%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">AST</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">4%</td> </tr> <tr> <td styleCode="Lrule Rrule">Urine RBC (Hematuria) (&gt;75 RBC/HPF)</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">3%</td> </tr> </tbody> </table>

<table width="75%"> <caption>Table 4 Lipid Values, Mean Change from Baseline, Reported in Subjects Receiving GENVOYA or STRIBILD in Studies 104 and 111<footnote>Excludes subjects who received lipid lowering agents during the treatment period.</footnote> </caption> <col align="left" valign="middle" width="28%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="18%"/> <thead> <tr styleCode="Botrule"> <th rowspan="3" styleCode="Lrule Rrule"/> <th colspan="2" styleCode="Rrule">GENVOYA N=866</th> <th colspan="2" styleCode="Rrule">STRIBILD N=867</th> </tr> <tr styleCode="Botrule"> <th align="center" styleCode="Rrule">Baseline</th> <th styleCode="Rrule">Week 144</th> <th styleCode="Rrule">Baseline</th> <th styleCode="Rrule">Week 144</th> </tr> <tr> <th align="center" styleCode="Rrule">mg/dL</th> <th styleCode="Rrule">Change<footnote ID="t4f2">The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 144 values.</footnote> </th> <th styleCode="Rrule">mg/dL</th> <th styleCode="Rrule">Change<footnoteRef IDREF="t4f2"/> </th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Total Cholesterol (fasted)</td> <td styleCode="Rrule">162 [N=647]</td> <td styleCode="Rrule">+31 [N=647]</td> <td styleCode="Rrule">165 [N=627]</td> <td styleCode="Rrule">+14 [N=627]</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Triglycerides (fasted)</td> <td styleCode="Rrule">111 [N=647]</td> <td styleCode="Rrule">+29 [N=647]</td> <td styleCode="Rrule">115 [N=627]</td> <td styleCode="Rrule">+17 [N=627]</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">LDL-cholesterol (fasted)</td> <td styleCode="Rrule">103 [N=647]</td> <td styleCode="Rrule">+20 [N=643]</td> <td styleCode="Rrule">107 [N=628]</td> <td styleCode="Rrule">+8 [N=628]</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">HDL-cholesterol (fasted)</td> <td styleCode="Rrule">47 [N=647]</td> <td styleCode="Rrule">+7 [N=647]</td> <td styleCode="Rrule">46 [N=627]</td> <td styleCode="Rrule">+3 [N=627]</td> </tr> <tr> <td styleCode="Lrule Rrule">Total Cholesterol to HDL ratio</td> <td styleCode="Rrule">3.7 [N=647]</td> <td styleCode="Rrule">0.2 [N=647]</td> <td styleCode="Rrule">3.8 [N=627]</td> <td styleCode="Rrule">0.1 [N=627]</td> </tr> </tbody> </table>