methadone and Chronic Hepatitis C

methadone has been researched along with Chronic Hepatitis C in 65 studies

Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.
6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4.

Research

Studies (65)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01911845)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment. (NCT01911845)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

Percentage of Participants With Virologic Relapse Post-treatment

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days. (NCT01911845)
Timeframe: From the end of treatment through 12 weeks after the last actual dose of study drug

Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (NCT02105688)
Timeframe: 12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA NCT02105688)
Timeframe: 24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)

Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period. (NCT02105688)
Timeframe: DB Treatment period (up to Study Week 12)

Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period. (NCT02105688)
Timeframe: DB Treatment period plus first 14 follow-up days (up to Study Week 14)

Mean Score for Overall Local Injection Site Reaction

Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae. (NCT00087568)
Timeframe: Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60

Mean Score of Beck Depression Inventory Over Time

The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84

Mean Score of Fatigue Severity Over Time

"The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with no fatigue ('0' being the best) and at the other end with greater fatigue ('100' being the worst). Longer distance on the scale from no fatigue indicated greater fatigue. FSS values are presented based on questionnaire and visual analog scale." (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84

Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time

Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses. (NCT00087568)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, and 84

Number of Participants With Abnormal Vital Signs

"Abnormal vital signs were defined as~Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%~Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.~Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat" (NCT00087568)
Timeframe: From screening (Day -21 to Day -1) to Week 84

Number of Participants With Individual Flu-like Symptom

"Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The yes/no questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered yes to the question Has the patient experienced any flu-like symptoms since the last visit? all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported." (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 12, 36, 60 and 84

Number of Participants With Marked Laboratory Abnormalities

Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506 (NCT00087568)
Timeframe: Up to Week 84

Number of Participants With Normal Serum Alanine Transaminase Levels Over Time

The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L. (NCT00087568)
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84

Number of Participants With Serious Adverse Events and Adverse Events

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. (NCT00087568)
Timeframe: Up to Week 84

Number of Pegasys and Ribavirin Therapy Completers

Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12. (NCT00087568)
Timeframe: 36 weeks for Non-Tolerators and 60 weeks for Non-Responders

Reviews

5 reviews available for methadone and Chronic Hepatitis C

Trials

17 trials available for methadone and Chronic Hepatitis C

Other Studies

43 other studies available for methadone and Chronic Hepatitis C