GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective:
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1 GSK Medicine: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) Study Number: Title: A IIIb, randomized, open-label study of the safety, efficacy, and tolerability of switching to a fixed-dose combination of abacavir/dolutegravir/lamivudine from current antiretroviral regimen compared with continuation of the current antiretroviral regimen in HIV-1 infected adults who are virologically suppressed, final results. Rationale: The purpose of Study was to compare switching from current antiretroviral regimen to administered once daily in the treatment of human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed. : IIIb Study Period: 06-May-2014 to 29-Dec-2015 (week 48 and continuation phase) Study Design: Study is a 48-week, IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. The primary analysis took place after the last subject completed the Week 24 visit. Additional analyses were conducted after the last subject completed the Week 48 visit and after the last subject withdrew from the study or transitioned to commercial supplies (i.e., completes the Continuation ). The study included a Screening Period (14 to 28 days), a Randomized/ (24 weeks), a (24 weeks), and a Continuation. Centers: This study was conducted at 96 investigational centers (defined as having enrolled one or more subjects): 85 centers in the United States (4 of the 85 were in Puerto Rico) and 11 centers in Canada. Indication: HIV-1 infected adults who are virologically suppressed Treatment: Eligible subjects were randomly assigned 1:1 to continue their current regimen or were switched to once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen switched to and were followed for an additional 24 weeks. Individuals initially randomly assigned to continued on that treatment arm for an additional 24 weeks. Subject randomization was stratified by current antiretroviral therapy () third-agent class (protease inhibitor [PI], non-nucleoside nucleoside reverse transcriptase inhibitor [NNRTI], or integrase inhibitor [INI]). All subjects who successfully completed a total of 48 weeks of treatment continued to have access to in the Continuation until it was either locally approved and commercially available, the subject no longer derived clinical benefit, the subject met a protocoldefined reason for discontinuation, or development of was terminated. Objective: The primary objective was to demonstrate the non-inferior antiviral activity of administered once daily compared with continuation of current antiretroviral regimen over 24 weeks in HIV-1 infected adult subjects with virologic suppression. Primary Outcome (Endpoint)/Efficacy: The primary efficacy endpoint for this study was the proportion of subjects with plasma HIV-1 RNA <50 c/ml at Week 24 using the Snapshot (Missing, Switch, or Discontinuation = Failure [MSDF]) algorithm for the Intent-to-Treat Exposed (ITT-E) Population. Secondary Outcome (Endpoints)/Efficacy: The following were the secondary efficacy endpoints for this study: Change from Baseline in CD4+ cell counts at Week 24 Tertiary Outcome (Endpoints)/Efficacy: The following were the tertiary efficacy endpoints for this study: Proportion of subjects with plasma HIV-1 RNA <50 c/ml at Week 48; Change from Baseline in CD4+ cell counts at Week 48; Incidence of disease progression (HIV-associated conditions, AIDS, and death) over time. Statistical Methods: The primary endpoint was the proportion of subjects with plasma HIV-1 RNA <50 c/ml at Week 24 (using the FDA Snapshot analysis). Non-inferiority was based on the lower bound of a 2-sided 95% confidence interval (CI) for the difference in response rates between the 2 treatment arms being greater than -10%. The power of this study was based on a response rate of 85%. Assuming this rate of response at Week 24 for both arms, the study required 269 evaluable subjects per treatment arm to have 90% power with a 10% non-inferiority margin and a 1-sided 2.5% significance level. The primary efficacy analyses were conducted based on the ITT-E Population, which consisted of all subjects who were randomized to and received at least 1 dose of IP or were randomized to remain on current regimen and continued in the study past Day 1. Subjects were assessed according to their randomized treatment, 1
2 regardless of the treatment they received. The PP Population consisted of all subjects who were in the ITT-E Population with the exception of those with a significant protocol deviation before Week 24. The PP Population was used for supporting sensitivity analyses of the primary endpoint analysis. No PP Population was defined for the. The ITT-E Population and Safety Population were the primary populations used for the Week 48 efficacy and safety analyses. These populations were defined as follows: All subjects originally randomized to who received at least 1 dose of study treatment; Subjects originally randomized to continue on their current regimen and who completed the and received at least 1 dose of upon switching at Week 24. Subjects were not included in summaries/analyses of data if they discontinued treatment prior to Week 24 while on their current regimen. For the -ITT-E Population, subjects were assessed according to their randomized treatment, regardless of the treatment they received unlike the Safety Population. At Week 48, tolerability and long-term safety over time following switch to was assessed by the incidence of AEs and SAEs and graded laboratory toxicities, as well as summaries of laboratory tests and vital sign measurements. For the analyses of the health outcome endpoints, change from Baseline in the HIV treatment satisfaction questionnaire (TSQ) (2006) of total scores, general satisfaction/clinical subscale scores, and lifestyle/ease subscale scores at Week 48 was measured. Any incidence of treatment-emergent genotypic and phenotypic resistance to NRTIs, NNRTIs, and INIs was summarized by treatment arm at Week 48. Two post hoc analyses were performed: A post hoc sensitivity analysis was performed to include subject data for those individuals who were included in the ITT-E Population, but whose week 48 visit was outside of the allowed visit window. This affected 16 subjects of whom 10 were taking commercial Triumeq at week 48; thus, for 10 subjects, their HIV-RNA results at week 48 were considered on treatment. This analysis is considered to be the main analysis at Week 48 and represents the clinical reality of the study (original ITT-E not presented here). A second post hoc sensitivity analysis was performed to exclude n=20 subjects randomized, where the Sponsor became aware of GCP noncompliance issues in another ViiV Healthcare-sponsored study. Study Population: The following were the main inclusion criteria: HIV-1 infected men or women 18 years of age; two consecutive plasma HIV-1 RNA measurements <50 c/ml within the last year and plasma HIV-1 RNA <50 c/ml at Screening; subject on current regimen (whether first or second line combination [c]) for at least 6 months prior to Screening; subject with plasma HIV-1 RNA <50 c/ml within 6 months of start of initial c regimen and no plasma HIV-1 RNA >200 c/ml following initial suppression; subject was negative for the human leukocyte antigen B*5701 allele. The following were the main exclusion criteria: any evidence of an active (Centers for Disease Control and Prevention Category C) disease (exceptions included cutaneous Kaposi s sarcoma not requiring systemic therapy and historic CD4+ cell counts of <200 cells/mm 3 ); subjects with any degree of hepatic impairment; subjects positive for hepatitis B virus surface antigen at Screening or with an anticipated need for hepatitis C virus therapy during the study; subjects who had a history of use of only mono or dual nucleoside reverse transcriptase inhibitor (NRTI) therapy prior to starting c; subjects who used etravirine at time of switch; subjects who used DTG at time of switch; subjects with evidence of primary viral resistance based on the presence of any resistance associated major PI, NRTI, NNRTI, or INI mutation in any prior resistance genotype assay result; creatinine clearance of <50 ml/min/1.73m 2 using Modification of Diet in Renal Disease. The primary endpoint of this study was reported at Week 24. The Week 24 results are presented here for 2
3 completeness, along with the Week 48 results. Randomization/ ITT-E Population ITT-E Population Number of Subjects: Planned, N Randomised, N Randomised and Exposed, N Completed, 239 (87) 244 (88) 230 (84) 230 (94) Premature Withdrawal: 36 (13) 33 (12) 45 (16) 14 (6) Withdrawn due to AE, 10 (4) 0 10 (4) 4 (2) Withdrawn for Other Reasons, 26 (9) 33 (12) 35 (13) 10 (4) Demographics N Females: Males 38:237 40:238 38:237 32:212 Age, years ( 45 (22-74) 47 (22-80) 45 (22-74) 47 (23-80) White, 177 (64) 184 (66) 178 (65) 165 (68) Baseline CD4+ (cells/mm 3 ), < (30) 91 (33) 83 (30) 66 (27) (70) 186 (67) 192 (70) 178 (73) Time Since First Until Screening (months) Primary Efficacy Results Proportion of Subjects With Plasma HIV-1 RNA <50 c/ml at Week 24/48 Snapshot Analysis n(%) Timepoint Week 24 Week 48 Virologic Success 233/275 (85) 245/278 (88) 227/275 (83)* 224/244 (92)* Adjusted difference (95% CI) -3.4, (-9.1, 2.4) Secondary Outcome Results: *Commercial IP sensitivity analysis is considered the primary analysis at Week 48 (n=10 subjects taking commercial at Week 48; results considered on-treatment) N=278 * Change From Baseline in CD4+ Cell Count (cells/mm 3 ) Baseline ( n=275;, n=278; ES n=275; LS n=244) Week 24 ( n=238;, n=248; ES n=238) (460.0, 812.0) 50.0 (-48.0, 130.0) (444.0, 794.0) 11.0 (-60.0, 103.5) (460.0, 812.0) 50.0 (-48.0, 130.0) (468.5, 810.0) 3
4 Week 48 (ES n=226; LS n=223) *Baseline is the last assessment prior to switch (-45.0, 142.0) 34.0 (-46.0, 131.0) Virology: No subjects met the confirmed virologic withdrawal criteria; hence, no resistance was identified throughout the study Safety Results: For the, on-treatment AEs and SAEs for both the and treatment groups were defined as events with onset after the start date of study drug (Day 1), but not after the Week 24 visit. For the, for the group on-treatment AEs and SAEs were defined as events with onset after the start date of study drug (Day 1), but not after the Week 48 visit. For the Late Switch group on-treatment AEs and SAEs were defined as events with onset after the date of the Week 24 visit, but not after the Week 48 visit. The Most Frequent (>=5% in any treatment group) On-treatment Adverse Events in the Randomized/Early and Late Switch [sorted by Frequency] Randomization/ Safety Population* N=276 N=277 Safety Population Subjects with any AE 183 (66) 129 (47) 206 (75) 146 (60) Nausea 27 (10) 3 (1) 28 (10) 15 (6) Diarrhoea 17 (6) 4 (1) 20 (7) 9 (4) Upper respiratory tract infection 21 (8) 20 (7) 35 (13) 22 (9) Fatigue 19 (7) 3 (1) 22 (8) 6 (2) Cough 14 (5) 8 (3) 17 (6) 6 (2) Headache 13 (5) 4 (1) 17 (6) 6 (2) Nasopharyngitis 10 (4) 6 (2) 13 (5) 6 (2) Insomnia 10 (4) 1 (<1) 14 (5) 9 (4) * One subject was entered into the study while receiving DTG + ABC/3TC and was randomly assigned to continue c. This subject therefore is counted in the c group in the ITT-E Population, but in the group in the Safety Population. Serious Adverse Events - On-treatment Randomized/Early and [n considered by the investigator to be related to study medication] N=276 System Organ Class Preferred Term Subjects With any SAE, Included both fatal and nonfatal events 6 (2) [0] 5 (2) [0] 9 (3%) [0] 6 (2%) [0] Cardiac disorders Cardiac failure congestive 1 (<1) [0] 0 1 (<1) [0] 0 Myocardial infarction (<1%) [0] Infections and infestations Cellulitis 1 (<1) [0] 1 (<1) [0] 1 (<1) [0] 0 Diverticulitis (<1) [0] Gastroenteritis (<1) [0] 0 Meningitis bacterial 0 1 (<1) [0] 0 0 Pneumonia bacterial (<1) [0] 0 Pyelonephritis (<1) [0] 0 Subcutaneous abscess (<1) [0] 4
5 Musculoskeletal and connective tissue disorders Intervertebral disc degeneration 0 1 (<1) [0] 0 0 Nervous system disorders Cerebrovascular accident 1 (<1) [0] 0 1 (<1) [0] 0 Hemiparesis 1 (<1) [0] Hypoaesthesia 1 (<1) [0] Speech disorder 1 (<1) [0] Psychiatric disorders Suicide attempt 1 (<1) [0] 0 1 (<1) [0] 0 Renal and urinary disorders Nephrolithiasis 0 1 (<1) [0] 0 0 Social circumstances Homicide 1 (<1) [0] 0 1 (<1) [0] 0 Vascular disorders Aortic thrombosis 0 1 (<1) [0] 0 0 Hypertension (<1) [0] 0 Respiratory, thoracic and mediastinal disorders Asthma (<1) [0] 0 Pulmonary embolism (<1) [0] General disorders and administration site conditions Non-cardiac chest pain (<1) [0] 0 Injury, poisoning and procedural complications Femur fracture (<1) [0] Investigations Alanine aminotransferase increased (<1) [0] Subjects With Fatal SAEs, Homicide 1 (<1) [0] 0 1 (<1) [0] 0 Myocardial infarction (<1) [0] Conclusion: In virologically suppressed patients, switching to once daily was non-inferior to continuing c, with no evidence of virologic failure or treatment emergent resistance through 48 weeks. Early switch subjects also maintained virologic suppression from Week 24 through Week 48. There were fewer withdrawals due to AEs in the vs. arm. The safety profile of in STRIIVING is consistent with current labeling for. 5
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