Potential Trajectory of North Korea's Economic Struggles
Delve into the complex economic challenges facing North Korea with a focus on growth constraints, investment dynamics, and the shift towards a mixed market system. Explore the impact of savings, efficiency, and external sources on the country's economic future, as outlined by William B. Brown. Gain insights into the historical context and stylized economic systems influencing North Korea's development path.
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Switch to ATV/r + 3TC SALT Study
SALT Study: switch to ATV/r + 3TC Design Randomisation* 1: 1 Open-label W48 W96 18 years N = 143 ATV/r 300/100 mg QD + 2 NRTI (investigator-selected) Stable 3-drug regimen No previous treatment failure HIV RNA < 50 c/mL > 6 months Switch for toxicity, intolerance or simplification No resistance to study medications HBs Ag negative ATV/r 300/100 mg + 3TC 300 mg QD N = 143 * Randomisation was stratified on active HCV infection and previous treatment (NNRTI, PI/r, CCR5 antagonist, integrase inhibitor) Objective Primary Endpoint: proportion with treatment success at W48 Treatment failure: treatment discontinuation or modification for any cause or confirmed virologic rebound (2 consecutive HIV RNA > 50 c/mL) Non-inferiority of ATV/r + 3TC (per protocol) ; lower limit of the 95% CI for the difference = -12% Perez-Molina JA. Lancet Infect Dis 2015;15:775-84 SALT
SALT Study: switch to ATV/r + 3TC Baseline characteristics and disposition at W48 ATV/r + 2 NRTI N = 143 ATV/r + 3TC N = 143 Female 22% 31% Baseline CD4/mm3, median 614 579 Nadir CD4/mm3, median 215 211 Duration of HIV RNA < 50 c/mL (months), median 29 27 Duration of ART prior to study entry, median 41 39 HCV co-infection (RNA positive) 20% 20% Reason for switching Simplification Toxicity Intolerance 80% 14% 4% 74% 22% 3% Switched treatment NNRTI PI/r 32% 66% 33% 64% Discontinued at W48, N (%) 29 (20%) 21 (15%) Adverse event / confirmed virologic failure 10 / 4 3 / 5 Withdrew consent / lost to follow-up 9 / 4 7 / 4 Perez-Molina JA. Lancet Infect Dis 2015;15:775-84 SALT
SALT Study: switch to ATV/r + 3TC Efficacy and Safety Results (W48) HIV RNA < 50 c/mL at W48 (Per protocol, TLOVR) Confirmed virologic rebound ATV/r + 2 NRTI ATV/r + 3TC N 4 5 ATV/r + 2 INTI ATV/r + 3TC Emergence of resistance mutations 1 (M184V) 0 % 100 Safety, N (%) 83 80 78 ATV/r + 2 NRTI N = 141 ATV/r + 3TC N = 140 60 AEs leading to discontinuation 10 (7.2%) 3 (2.2%) Grade 3-4 AEs Hyperbilirubinemia Icterus Liver function test Hyperlipidemia Thrombocytopenia 78 (55%) 71 2 2 2 1 77 (55%) 72 0 2 3 2 40 20 105/ 135 111/ 113 0 Severe adverse events (none related to study medication) 8 6 (95%CI) 6 (- 5 ; 16) Perez-Molina JA. Lancet Infect Dis 2015;15:775-84 SALT
SALT Study: switch to ATV/r + 3TC Efficacy and Safety Results (W96) HIV RNA < 50 c/mL at W96 (Per protocol, TLOVR) Confirmed virologic rebound ATV/r + 2 NRTI ATV/r + 3TC N 5 9 ATV/r + 2 INTI ATV/r + 3TC Samples amplified 2/5 3/9 Emergence of resistance mutations % 100 1 (M184V) 0 80 Safety, N (%) 74.4 73.9 ATV/r + 2 NRTI N = 141 ATV/r + 3TC N = 140 60 AEs leading to discontinuation 10 (7.1%) 7 (5.0%) 40 Grade 3-4 AEs Hyperbilirubinemia Jaundice Liver function test Hyperlipidemia Thrombocytopenia 99 (70%) 66 1.4 0.7 2.1 0.7 99 (71%) 65 0 2.1 2.1 1.4 20 99/ 134 99/ 133 0 (95%CI) 0.5 (- 9.9 ; 11) Changes at W96 in triglycerides Changes at W96 in total cholesterol - 6.2% - 1.9% + 12.1% (p < 0.003) + 5.1% (p < 0.001) Perez-Molina JA, JAC 2017; 72:246-53 SALT
SALT Study: switch to ATV/r + 3TC Conclusion Switching to ATV/r + 3TC is effective, safe, and non-inferior to ATV/r + 2 NRTI in virologically suppressed HIV+ patients, who need change any antiretroviral previous triple therapy because of toxicity, intolerance or simplification Switching from a triple to a dual ATV-based regimen is not associated with an increased risk of virological failure, which was low in both groups, with most patients with virological failure with HIV RNA < 200 c/ml Frequency of blips throughout the 48 weeks was equivalent in both groups Only 1 patient (triple-treatment group) developed resistance mutation (M184V) Few patients discontinued the study in the 2 groups because of toxic effects, with treatment interruptions being significantly more frequent in the triple-treatment group No significant differences in change from baseline in neurocognitive function, neither renal function, bone mineral density, or fat gain or distribution between groups at week 96 Perez-Molina JA. Lancet Infect Dis 2015;15:775-84, Perez-Molina JA, JAC 2017; 72:246-53 SALT
