Prior to start of everolimus, the following three categories of patients should be tested for hepatitis B viral load and serologic markers, that is, HBV-DNA, HBsAg, hepatitis B surface (HBs) antibody (Ab), and hepatitis B core (HBc) Ab\r\n* All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal and Greece\r\n* Patients with any of the following risk factors:\r\n** Known or suspected past hepatitis B infection,\r\n** Blood transfusion(s) prior to ,\r\n** Current or prior intravenous (IV) drug users,\r\n** Current or prior dialysis,\r\n** Household contact with hepatitis B infected patient(s),\r\n** Current or prior high-risk sexual activity,\r\n** Body piercing or tattoos,\r\n** Mother known to have hepatitis B\r\n** History suggestive of hepatitis B infection, e.g., dark urine, jaundice, right upper quadrant pain\r\n** Additional patients at the discretion of the investigator
Patients with any of the following risk factors for hepatitis C should be tested using quantitative RNA-polymerase chain reaction (PCR):\r\n* Known or suspected past hepatitis C infection (including patients with past interferon curative treatment),\r\n* Blood transfusions prior to ,\r\n* Current or prior IV drug users,\r\n* Current or prior dialysis,\r\n* Household contact of hepatitis C infected patient(s),\r\n* Current or prior high-risk sexual activity,\r\n* Body piercing or tattoos\r\n* At the discretion of the investigator, additional patients may also be tested for hepatitis C
Active hepatitis B or C with uncontrolled disease\r\n* Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus surface antigen (HBsAg) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B virus (HBV) infection
Active hepatitis B or C with uncontrolled disease; NOTE: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B core immunoglobulin M antibody (HBcIgM Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody screen (HCV Ab Scrn) w/reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B (HBV) infection
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within  months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n** Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C); NOTE: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) and hepatitis C virus (HCV) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Liver disease such as cirrhosis or severe hepatic impairment (patient with a Child-Pugh score B or\r\nC). A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
Patients must not have a known diagnosis of hepatitis B or C; patients with the following risk factors must have hepatitis screening pre-treatment:\r\n* Blood transfusions prior to \r\n* Current or prior intravenous (IV) drug users\r\n* Current or prior dialysis\r\n* Household contact with a hepatitis B or C patient\r\n* Current or prior high-risk sexual activity\r\n* History of jaundice
History of hepatitis B or C; Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) serology, DNA and/or hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; if no positive medical history for risk factors, serology is not required
Individuals with a documented history of previous or current hepatitis B or C infection; hepatitis B or C serologic screening is not required prior to enrollment, except in participants with any of the following high-risk features:\r\n* Suspected (but not documented) previous hepatitis B or C infection\r\n* Blood transfusion(s) prior to \r\n* Current or prior IV drug use\r\n* Current or prior dialysis\r\n* Household contact with hepatitis B or C infected individual\r\n* Mother with known hepatitis B or C infection\r\n* Current or prior high-risk sexual activity\r\nFor participants with any of the above high risk features: study enrollment will only be allowed if hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) or hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV)-ribonucleic acid (RNA) polymerase chain reaction (PCR) are negative within  days prior to study enrollment; any patient with a positive result on any of these screening tests is ineligible
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is % of the normal predicted value and/or O saturation that is =< % at rest on room air\r\n* Uncontrolled diabetes, defined as fasting serum glucose > . x ULN (Note: optimal glycemic control should be achieved before starting trial therapy)\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n** Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; testing for hepatitis B viral load and serologic markers (HBV-DNA, hepatitis B virus surface antigen [HBsAg], hepatitis B virus surface antibody [HBs Ab], and hepatitis B virus core antibody [HBc Ab]) and HCV RNA PCR are required at screening for all patients in the following risk categories:\r\n* All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece\r\n* Patients with any of the following risk factors:\r\n** Known or suspected past hepatitis B infection\r\n** Blood transfusion(s) prior to \r\n** Current or prior IV drug users\r\n** Current or prior dialysis\r\n** Household contact with hepatitis B infected patient(s)\r\n** Current or prior high-risk sexual activity\r\n** Body piercing (other than ears) or tattoos\r\n** Mother known to have hepatitis B\r\n** History suggestive of hepatitis B infection e.g., dark urine, jaundice, right upper quadrant pain\r\n* Additional patients at the discretion of the investigator
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* History of liver disease, such as cirrhosis or chronic active hepatitis B and C\r\n* Presence of hepatitis B surface antigen (HbsAg)\r\n* Presence of hepatitis C antibody test (anti-hepatitis C virus [HCV]) \r\nNote: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Current severe hepatic impairment; Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: \r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within  months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Concomitant use of drugs with a risk of causing torsades de pointes\r\n* Uncontrolled diabetes as defined by fasting serum glucose > . x ULN; note: optimal glycemic control should be achieved before starting trial therapy\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis; note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive human immunodeficiency virus (HIV) test result (enzyme-linked immunosorbent assay [ELISA] and Western blot); hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* History of liver disease, such as cirrhosis or chronic active hepatitis B and C\r\n* Presence of hepatitis B surface antigen (HBsAg)\r\n* Presence of hepatitis C antibody test (anti-HCV)\r\n* Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection