HIV Infections
Conditions
Brief summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female * 18 years or older * written informed consent * The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC
Exclusion criteria
* Pregnant patients * The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | 36 months | Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Viral Load After 12 Months From Baseline. | Baseline and 12 months | The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load. |
| Changes in the Viral Load After 36 Months From Baseline. | Baseline and 36 months | The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load. |
| Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | Baseline and 12 months | The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count. |
| Changes in the CD4+ Cell Count After 36 Months From Baseline. | Baseline and 36 months | The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count. |
| Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (ALT) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (AST) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (ALT) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (AST) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | Baseline and 36 months | The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
| Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | Baseline and 12 months | The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment-naive Patients Patients who were not pretreated with HIV therapy. | 288 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. | 203 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL. | 93 |
| Patients With Baseline Viral Load Not Documented Patients who could not be assigned to one of the three subgroups and had no documented viral load value. | 21 |
| Total | 605 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 34 | 20 | 10 | 3 |
| Overall Study | Data not available | 14 | 3 | 7 | 1 |
| Overall Study | Lack of Efficacy | 17 | 9 | 10 | 1 |
| Overall Study | Lost to Follow-up | 26 | 10 | 3 | 2 |
Baseline characteristics
| Characteristic | Treatment-naive Patients | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Patients With Baseline Viral Load Not Documented | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 9.9 | 43.8 years STANDARD_DEVIATION 9.6 | 40.9 years STANDARD_DEVIATION 9.4 | 43.6 years STANDARD_DEVIATION 7.8 | 41.6 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 32 Participants | 29 Participants | 6 Participants | 0 Participants | 67 Participants |
| Sex: Female, Male Male | 256 Participants | 174 Participants | 87 Participants | 21 Participants | 538 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 288 | 33 / 203 | 22 / 93 | 3 / 21 |
| serious Total, serious adverse events | 17 / 288 | 12 / 203 | 5 / 93 | 0 / 21 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Time frame: 36 months
Population: Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with serious AEs | 17 participants |
| Treatment-naive Patients | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with any AE | 168 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with any AE | 110 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with serious AEs | 12 participants |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with any AE | 51 participants |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with serious AEs | 5 participants |
| Patients With Baseline Viral Load Not Documented | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with serious AEs | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs | Patients with any AE | 10 participants |
Secondary
Changes in the CD4+ Cell Count After 36 Months From Baseline.
The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
Time frame: Baseline and 36 months
Population: Patients from FAS with values for CD4+ at baseline and after 36 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the CD4+ Cell Count After 36 Months From Baseline. | 223.7 cells/mm^3 | Standard Deviation 200.4 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the CD4+ Cell Count After 36 Months From Baseline. | 2.8 cells/mm^3 | Standard Deviation 221.3 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the CD4+ Cell Count After 36 Months From Baseline. | 116.0 cells/mm^3 | Standard Deviation 317.7 |
| Patients With Baseline Viral Load Not Documented | Changes in the CD4+ Cell Count After 36 Months From Baseline. | 63.5 cells/mm^3 | Standard Deviation 152 |
Secondary
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
Time frame: Baseline and 12 months
Population: Patients from FAS with values for CD4+ at baseline and after 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | 188.7 cells/mm^3 | Standard Deviation 165 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | 54.6 cells/mm^3 | Standard Deviation 145.3 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | 82.8 cells/mm^3 | Standard Deviation 269.5 |
| Patients With Baseline Viral Load Not Documented | Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. | 128.0 cells/mm^3 | Standard Deviation 223.4 |
Secondary
Changes in the Laboratory Data (ALT) After 12 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for ALT at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (ALT) After 12 Months From Baseline | 5.6 U/L | Standard Deviation 20.5 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (ALT) After 12 Months From Baseline | 10.2 U/L | Standard Deviation 28.8 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (ALT) After 12 Months From Baseline | 7.0 U/L | Standard Deviation 28.4 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (ALT) After 12 Months From Baseline | 9.7 U/L | Standard Deviation 33 |
Secondary
Changes in the Laboratory Data (ALT) After 36 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for ALT at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (ALT) After 36 Months From Baseline | 16.2 U/L | Standard Deviation 107.1 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (ALT) After 36 Months From Baseline | 4.0 U/L | Standard Deviation 33.7 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (ALT) After 36 Months From Baseline | 11.8 U/L | Standard Deviation 27.7 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (ALT) After 36 Months From Baseline | 5.2 U/L | Standard Deviation 26.1 |
Secondary
Changes in the Laboratory Data (AST) After 12 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for AST at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (AST) After 12 Months From Baseline | 1.7 U/L | Standard Deviation 19.1 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (AST) After 12 Months From Baseline | 4.4 U/L | Standard Deviation 24.7 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (AST) After 12 Months From Baseline | 3.0 U/L | Standard Deviation 20.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (AST) After 12 Months From Baseline | 8.3 U/L | Standard Deviation 32.4 |
Secondary
Changes in the Laboratory Data (AST) After 36 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for AST at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (AST) After 36 Months From Baseline | 7.3 U/L | Standard Deviation 75.3 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (AST) After 36 Months From Baseline | 0.1 U/L | Standard Deviation 24.6 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (AST) After 36 Months From Baseline | 5.5 U/L | Standard Deviation 27.1 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (AST) After 36 Months From Baseline | -2.7 U/L | Standard Deviation 19.6 |
Secondary
Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | 0.2 mg/dL | Standard Deviation 20.6 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | -3.6 mg/dL | Standard Deviation 16.9 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | 0.3 mg/dL | Standard Deviation 24.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline | -8.4 mg/dL | Standard Deviation 9.2 |
Secondary
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | 1.6 mg/dL | Standard Deviation 27.2 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | 0.0 mg/dL | Standard Deviation 19.9 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | 0.7 mg/dL | Standard Deviation 36.4 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline | -7.2 mg/dL | — |
Secondary
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Creatinine at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.2 |
Secondary
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Creatinine at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.2 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline | 0.0 mg/dL | Standard Deviation 0.1 |
Secondary
Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Gamma GT at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | 32.9 U/L | Standard Deviation 72.4 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | 25.4 U/L | Standard Deviation 57.7 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | 23.7 U/L | Standard Deviation 62.3 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline | 9.1 U/L | Standard Deviation 42.6 |
Secondary
Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Gamma GT at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | 52.3 U/L | Standard Deviation 102.5 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | 45.0 U/L | Standard Deviation 112.6 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | 50.3 U/L | Standard Deviation 50.3 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline | 12.9 U/L | Standard Deviation 48.1 |
Secondary
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | 0.6 g/dL | Standard Deviation 1.1 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | 0.3 g/dL | Standard Deviation 1.2 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | 0.3 g/dL | Standard Deviation 0.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline | 0.5 g/dL | Standard Deviation 1.1 |
Secondary
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | 0.7 g/dL | Standard Deviation 0.9 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | 0.2 g/dL | Standard Deviation 1.2 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | 0.5 g/dL | Standard Deviation 1.4 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline | -0.1 g/dL | Standard Deviation 1.6 |
Secondary
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | 12.7 mg/dL | Standard Deviation 14.3 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | 4.2 mg/dL | Standard Deviation 15 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | 10.9 mg/dL | Standard Deviation 14.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline | -13.2 mg/dL | Standard Deviation 29.1 |
Secondary
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | 11.0 mg/dL | Standard Deviation 21.4 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | 4.4 mg/dL | Standard Deviation 20.7 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | 11.1 mg/dL | Standard Deviation 11.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline | -19.6 mg/dL | Standard Deviation 38.7 |
Secondary
Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | 12.1 mg/dL | Standard Deviation 29.6 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | 2.4 mg/dL | Standard Deviation 35.7 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | 14.4 mg/dL | Standard Deviation 30.5 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline | 13.6 mg/dL | Standard Deviation 10.1 |
Secondary
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | 12.4 mg/dL | Standard Deviation 25.8 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | 15.8 mg/dL | Standard Deviation 38.1 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | 23.8 mg/dL | Standard Deviation 44.7 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline | 22.7 mg/dL | Standard Deviation 27.9 |
Secondary
Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | 25.2 mg/dL | Standard Deviation 36.2 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | -3.0 mg/dL | Standard Deviation 43.2 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | 15.8 mg/dL | Standard Deviation 32.8 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline | 16.4 mg/dL | Standard Deviation 9.7 |
Secondary
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | 24.1 mg/dL | Standard Deviation 39 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | 2.0 mg/dL | Standard Deviation 44.4 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | 24.2 mg/dL | Standard Deviation 42.4 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline | 41.1 mg/dL | Standard Deviation 12.9 |
Secondary
Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 12 months
Population: Patients from TS with evaluable data for Triglycerides at baseline and at month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | 7.9 mg/dL | Standard Deviation 106.7 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | -61.6 mg/dL | Standard Deviation 180.2 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | -24.0 mg/dL | Standard Deviation 78.9 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline | 16.3 mg/dL | Standard Deviation 47.2 |
Secondary
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Time frame: Baseline and 36 months
Population: Patients from TS with evaluable data for Triglycerides at baseline and at month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | -3.4 mg/dL | Standard Deviation 91.3 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | -73.7 mg/dL | Standard Deviation 252.6 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | -17.2 mg/dL | Standard Deviation 98 |
| Patients With Baseline Viral Load Not Documented | Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline | 34.2 mg/dL | — |
Secondary
Changes in the Viral Load After 12 Months From Baseline.
The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
Time frame: Baseline and 12 months
Population: Patients from FAS with values for viral load at baseline and after 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Viral Load After 12 Months From Baseline. | -3.3 Log10 copies/ml | Standard Deviation 1.3 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Viral Load After 12 Months From Baseline. | -0.1 Log10 copies/ml | Standard Deviation 0.8 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Viral Load After 12 Months From Baseline. | -1.9 Log10 copies/ml | Standard Deviation 1.7 |
Secondary
Changes in the Viral Load After 36 Months From Baseline.
The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.
Time frame: Baseline and 36 months
Population: Patients from FAS with values for viral load at baseline and after 36 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Changes in the Viral Load After 36 Months From Baseline. | -3.4 Log10 copies/ml | Standard Deviation 1.4 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Changes in the Viral Load After 36 Months From Baseline. | -0.2 Log10 copies/ml | Standard Deviation 1.1 |
| Pretreated Patients, Baseline Viral Load > 50 Copies/mL | Changes in the Viral Load After 36 Months From Baseline. | -2.1 Log10 copies/ml | Standard Deviation 1.8 |