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Preliminary Results from the SCOLTA Project
on the Safety of Lopinavir/Ritonavir: An Italian Approach to Post-marketing
Monitoring
The SCOLTA project (Surveillance Cohort Long-term Toxicity Antiretrovirals)
is a system for online surveying of adverse
reactions to recently commercialized antiretroviral
drugs and a "sentinel" for unexpected and late adverse
reactions arising during any antiretroviral treatment (available
at: http://www.cisai.info).
To
date, 25 Italian departments of infectious diseases have participated
at the project. The New Drugs Project is a prospective, multicenter,
observational pharmaco-vigilance study involving 1 cohort of patients
for each new drug.
All
patients who were consecutively started on lopinavir (LPV),
tenofovir
(TDF), peginterferon
(IFN), atazanavir (ATZ),
enfuvirtide
(T-20), and tipranavir
(TPV) were enrolled.
All
grade III or IV adverse events (according to the AIDS Clinical Trials
Group definitions) are reported on the web site. The Unexpected
Events Project identifies unexpected adverse reactions during treatment
and reports them.
This
paper presents the preliminary findings for the New Drugs Project.
Results
· Between
October 1, 2002, and March 30, 2004, 1184 patients were enrolled.
· The
lopinavir/ritonavir (LPV/r) cohort comprises 703 patients, the TDF
cohort 585, IFN 35, ATZ 95, T-20 10, and TPV 8.
· So
far 100 grades III and IV adverse events have been reported, 73
in the LPV/r group.
· In
this cohort the rate of adverse events per 100 person-years was
14.2 on the basis of all patients treated, 9.8 for treatment-naive
patients, and 15 for treatment-experienced patients.
The
authors conclude, “These findings, though preliminary, show that
this data collection method gives timely real-life information from
which to assess the impact of short- and long-term toxicity of new
antiretroviral drugs.”
From the Department of Infectious Diseases,
Luigi Sacco Hospital, Milan, Italy; Department of Infectious Diseases,
Careggi Hospital, Florence, Italy; Department of Infectious Diseases,
Sant'Anna Hospital, Ferrara, Italy; Department of Infectious Diseases,
Pescara Hospital, Pescara, Italy; Department of Infectious Diseases,
Viterbo General Hospital, Viterbo, Italy; Department of Infectious
Diseases, Legnano General Hospital, Milan, Italy; and Department
of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy.
07/01/05
Reference
P
Bonfanti and others (Italian coordinators for the study of allergies
in HIV infection). An Italian Approach to Postmarketing Monitoring:
Preliminary Results From the SCOLTA (Surveillance Cohort Long-Term
Toxicity Antiretrovirals) Project on the Safety of Lopinavir/Ritonavir.
Journal of Acquired Immune Deficiency Syndromes 39(3):317-320.
July 1, 2005.
Additional Kaletra Articles
Pharmacokinetics
of Once-daily Lopinavir/Ritonavir and the Influence of Dose
Modifications
- 6/22/05
Reduced
Susceptibility to Protease Inhibitors (PI) in the Absence of Primary
PI Resistance-associated Mutations - 6/15/05
Immunological
Changes after HAART with Lopinavir-Ritonavir in Heavily Pretreated
Children
-
6/08/05
Lopinavir
Concentrations in Cerebrospinal Fluid Exceed the 50% Inhibitory
Concentration for HIV -
5/27/05
Relationship
between Adherence and the Development of Resistance in Antiretroviral-Naive
HIV Patients Receiving Lopinavir/Ritonavir or Nelfinavir
-
5/27/05
The
Risk of Detectable HIV-1 RNA Loads or of PI or Lamivudine Resistance
Is Significantly Higher in Nelfinavir-treated Patients Than in
Lopinavir/ritonavir-treated Patients
-
5/20/05
Predictive
Factors of Lopinavir/Ritonavir Discontinuation for Drug-related
Toxicity in Highly Pretreated HIV Patients -
5/13/05
Virological
and Pharmacological Parameters Used to Predict the Response to Lopinavir-Ritonavir
in Heavily PI-experienced Patients -
5/11/05
Increased
Dose of Lopinavir/Ritonavir Compensates for Efavirenz-induced
Drug-drug Interaction in HIV Positive Children -
5/06/05
FDA Approves
Lopinavir/Ritonavir 800/200mg Once Daily for Treatment of
HIV in Therapy-naïve Adults - 5/04/05
Use
of Lopinavir/Ritonavir in HIV-infected Patients Failing First-line
Protease Inhibitor-based HAART - 4/20/05
Atazanavir
Plus Ritonavir or Saquinavir Compared to Lopinavir/Ritonavir
in Patients Experiencing Multiple Virological Failures - 4/11/05
Lopinavir/ritonavir
Combination and Total/HDL Cholesterol Ratio - 4/04/05
Lipid
Disorders in Treatment-naive HIV Patients Using Lopinavir/Ritonavir-based
HAART
-
3/25/05
Steady
State Pharmacokinetics of Amprenavir, Lopinavir and Efavirenz
Combinations
-
3/16/05
Kaletra
Independently Reduces HIV Replication in Cerebrospinal Fluid
G. Van den Brande and Others. Abstract 403. 
-
3/11/05
Virological
response and Resistance to Lopinavir/Ritonavir in Subtype
C Patients
Z. Grossman and Others. Abstract 719.
-
3/11/05
6-Month
Follow-up of Once-daily Lopinavir/ritonavir in HIV-infected
Children
G. Verweel and Others. Abstract 769. -
3/11/05
Kaletra
Independently Reduces HIV Replication in Cerebrospinal Fluid and
in the Brain
-
3/04/05
Steady
State Pharmacokinetics of Amprenavir, Lopinavir and Efavirenz
Combinations
-
2/28/05
Efavirenz
with Two Nucleoside Analogs Is Superior for Regimen Simplification
-
2/28/05
A
Comparison of Dyslipidemias Associated with Either Lopinavir/Ritonavir-
or Indinavir/Ritonavir-based Antiretroviral Therapy - 2/11/05
Combivir Plus PI Kaletra HIV
Prophylaxis May Increase Tolerability -
2/04/05
Development and Validation of a
Population Pharmacokinetic Model for Ritonavir -
2/04/05
Combining
Fosamprenavir with Lopinavir/Ritonavir Substantially Reduces
Amprenavir and Lopinavir Exposure: ACTG Protocol A5143 Results
-
1/31/05
First
Enzyme Immunoassay for the Quantification of Plasma and Intracellular
Lopinavir in HIV Patients
-
1/12/05
Lopinavir/Ritonavir
Plus Nevirapine as a Nucleoside-sparing Approach in Treatment-experienced
HIV Patients
-
1/12/05
Lack
of Effect of Gastric Acid Reducing Agents on Lopinavir/ritonavir
Plasma Concentrations in HIV-Infected Patients.
Richard J Bertz, PhD and others. Abstract 201.
Antiretroviral
Therapy in Special Populations: Response to Lopinavir/ritonavir,
Tenofovir DF, and Emtricitabine in Antiretroviral-Naïve Patients
by Gender, Race/Ethnicity, and Hepatitis Co-infection Status.
P Easterbrook and others. Abstract P15.
Immunologic,
Virologic and Metabolic Data from the CLARE (CORE Center Lopinavir/r
(LPV/r) Antiretroviral Effectiveness) Cohort.
A OM and others. Abstract 330.
Lopinavir/ritonavir
(LPV/r)-Based Therapy in Antiretroviral (ARV)-Naïve, HIV-Infected
Patients: 6-Year Follow-up of Study 720
R Gulick and others. Abstract P28.
Efficacy
and Tolerance of Lopinavir/ritonavir in Clinical Practice:
An Observational Prospective Cohort of 1278 Patients.
A. Lafeuillade and others. Abstract 140.
Adherence
in Combination with Lopinavir Inhibitory Quotient (IQ) and Number
of Active Antiretrovirals (ARVs) Predicts Virologic Response in
Highly ARV-Experienced Patients Receiving High-Dose Lopinavir/ritonavir
(LPV/r).
R Berth and others. Abstract P91.
Prevalence
of Multiple Protease Mutations at Positions 33, 82, 84 and 90 Among
PI-Experienced Patients and the Effect on Virologic Response to
Lopinavir/ritonavir-Based Regimens.
M King and others. Abstract P100.
Response
to Lopinavir/ritonavir-Based HAART and Its Dependence on
Prior ARV Experience: 24-Week Interim Analysis (VIHvir+ Study).
A. Burgos and others. Abstract 299.
Phase
3 Comparison of Lopinavir/ritonavir vs. Investigator-Selected
Protease Inhibitors in Single PI-Experienced, NNRTI-Naive Patients:
48-Week Results of Study M98-888.
R Pollard and others. Abstract PL3.2.
300-Week
Follow-Up of Lopinavir/Ritonavir-based Therapy in Treatment-naive
Patients - 11/03/04
Racial
Differences in Response to Efavirenz-containing Versus Lopinavir/Ritonavir-containing
Regimens - 11/03/04
48-Week
Final Results of Lopinavir/Ritonavir-Efavirenz Combination
Study - 11/03/04
Genotypic
and Phenotypic Resistance Observations Among Patients with Viremia
While on Lopinavir/Ritonavir "Monotherapy" - 11/03/04
Virologic
Response to a Once Daily Lopinavir/Ritonavir-based Regimen
in ARV-naive Patients Is Not Associated with Trough Lopinavir Concentrations
or Baseline HIV RNA and CD4 Count - 11/03/04
48-Week
Final Results of Lopinavir/Ritonavir-Efavirenz Combination
Study Comparative Study of Combivir + Efavirenz (2 Class Triple
Therapy) versus Trizivir + Tenofovir (Single Class Quadruple Therapy)
in Initial Therapy for HIV -
11/01/04
Less
Metabolic Disturbances with Atazanavir Than Lopinavir/Ritonavir -
11/01/04
Salvage
Therapy with Amprenavir, Lopinavir and Ritonavir 400 mg/d
Shows Significant Virological Efficacy - 10/15/04
Lopinavir/Ritonavir
Is an Effective Option for Salvage Therapy in PI-experienced Children
-
10/13/04
Simplification
of Therapeutic Drug Monitoring for Twice-Daily Regimens of Lopinavir/Ritonavir
-
10/04/04
Two-way
Interaction Seen Between Phenytoin and Lopinavir/Ritonavir
-
09/20/04
Evaluation of Risk Factors for Liver
Enzyme Elevation Among Treatment-experienced Patients Using Lopinavir/Ritonavir
-
09/20/04
Evaluation
of Two-year Efficacy and Pharmacokinetics of Indinavir/Ritonavir
400/100 mg -
09/20/04
Does
Lopinavir Cause Severe Hepatotoxicity in Patients HIV-HCV
Coinfection? -
08/25/04
Lopinavir/Ritonavir-based
Regimens Produce Sustained Immunologic and Virologic Response
- 08/13/04
Lopinavir
Plasma Levels May Predict Changes in Body Fat and Cholesterol
- 08/09/04
Maintenance
Therapy Using Lopinavir/Ritonavir Alone with Well-controlled
HIV Infection Shows Continued Viral Suppression and Immunologic
Benefit
-
07/30/04
Extensive
Genotype Testing During 5 Years of Lopinavir/Ritonavir Treatment
in Therapy-naive HIV Patients Confirms No PI Resistance
-
07/30/04
Simplification
to Lopinavir/Ritonavir Monotherapy from NNRTI-based HAART
in HIV Patients with Complete Viral Suppression
-
07/30/04
Abbott
Announces Submission of New Drug Application for Use of Once Daily
Lopinavir/Ritonavir in US and Europe
-
07/28/04
Lipids,
Metabolic Syndrome and Risk Factors for Future Cardiovascular Disease:
Highlights from the 15th International AIDS Conference
-
07/28/04
Higher
Doses of Lopinavir/Ritonavir May Provide Clinical Benefits
in Patients with Limited Treatment Options -
07/23/04
Lopinavir
Pharmacokinetic Variability in a Population of Heavily Treated Patients
-
07/23/04
Lopinavir/Ritonavir
and Saquinavir Hard Gel Combination Is an Effective Alternative
HAART Regimen -
07/21/04
Reduced
Lopinavir Exposure During Pregnancy: Preliminary Pharmacokinetic
Results from PACTG 1026 -
07/19/04
No
Lopinavir/Ritonavir or Tenofovir Resistance, and a Low Incidence
of FTC Resistance Found in Patients Treated for 48 Weeks with Once-daily
Lopinavir/Ritonavir + Tenofovir + FTC -
07/19/04
Risk
of Dyslipidemia in a Cohort of 382 HIV-infected Subjects Receiving
Lopinavir/Ritonavir -
07/19/04
Predictive
Factors of Lopinavir/Ritonavir Discontinuation for Toxicity -
07/19/04
 Extensive
Resistance Testing During 5 Years of Lopinavir/ritonavir
Treatment in Antiretroviral-Naive HIV-infected Patients: Results
from Study 720. -
07/19/04
Single-drug
HAART (Lopinavir/r) for maintenance of HIV viral supression
Week 24 results of a randomized, open-label, pilot clinical trial
Only Kaletra Study (OK) -
07/19/04
Lopinavir/ritonavir
(LPV/r) Safety, Tolerability and Efficacy in Hepatitis C and/or
Hepatitis B-infected Patients: Review of Clinical Trials. -
07/19/04
Higher
Doses of Lopinavir/ritonavir (LPV/r) in Highly Treatment-Experienced,
HIV-Infected Patients: 48-Week Safety/Efficacy Evaluation -
07/19/04
Evaluation
of Lopinavir/Ritonavir- Versus Efavirenz-based Therapy as
the Two First-line HAART Regimens for Treatment-naive Subjects
-
07/16/04
Simplification
to Lopinavir/Ritonavir Single-drug HAART: 24-week Results
of the OK Study -
07/16/04
Lipid
Changes in a Trial of Simplification with Lopinavir/Ritonavir
Single -drug HAART: 24-week Results in the OK Study -
07/16/04
Safety,
Tolerability and Effectiveness of Lopinavir/Ritonavir Appear
Comparable Among HIV Patients Coinfected with Hepatitis C and/or
Hepatitis B 7-14-04
The
Effects of Treatment with Lopinavir/Ritonavir on Romanian
Children with HIV - 07/14/04
Virological
Phenotype Switches in Salvage Therapy with Lopinavir/Ritonavir
in Heavily Pretreated, HIV Vertically-infected Children
- 07/14/04
Treatment
of Pediatric HIV in the US from 1987 to 2003 - 07/14/04
Double
PI Therapy with Lopinavir/Ritonavir + Saquinavir Is a Potent Option
as Salvage therapy But Is Not Suitable for Patients with Heavy PI
Resistance and Very Low CD4 Count - 07/14/04
Pilot
Study of Lopinavir/Ritonavir as Single Drug HAART in HIV
Positive Treatment-naive HIV Patients: Final 48-week Data - 07/12/04
Fosamprenavir
and Lopinavir/Ritonavir BID Are Both Effective Protease Inhibitors
for Patients Failing One or Two Prior PI-based Regimens - 07/12/04
Differences
in Rates of Diarrhea in HIV Patients Receiving Lopinavir-Ritonavir
or Nelfinavir - 07/09/04
Lopinavir-Ritonavir
Dose Adjustment and Therapeutic Drug Monitoring and Monitoring of
Liver Function May Allow Concomitant Use of Rifampin in HIV Patients
with Tuberculosis - 06/18/04
Pharmacological
Parameters Predicting Response to Lopinavir/Ritonavir
- 06/02/04
Dose Separation Strategies
to Overcome the Pharmacokinetic Interaction of a Triple Protease
Inhibitor Regimen Containing Fosamprenavir, Lopinavir and Ritonavir
05/03/04
Salvage Therapy with Lopinavir/Ritonavir
Leads to Decrease in HIV Viral Load and to Phenotypic Change in
HIV Vertically infected Children -
4/19/04
Lopinavir
Significantly Decreases the Amprenavir Concentration During Amprenavir
and Lopinavir/Ritonavir Combination Therapy -
4/09/04
As First Line HAART in Treatment-naïve
Patients, Indinavir/Ritonavir Appears Less Effective and More Toxic
Than Lopinavir/Ritonavir -
4/09/04
Risk of Metabolic Abnormalities
in HIV Patients Receiving Anti- Lopinavir/Ritonavir-based
HAART 4/09/04
Safety, Efficacy and Development
of Resistance of PI Lopinavir/Ritonavir: 48-week Results
4/05/04
A
Regimen of Amprenavir/ Ritonavir/ Lopinavir Produced Low Tolerance
and Did Not Prevent Decrease in Amprenavir Levels -
3/29/04
Deep Salvage Therapy with Amprenavir
and Lopinavir/Ritonavir: Partial Virologic Control and Substantial
CD4+ T-cell Recovery 03/24/04
4-year Follow-up Study of Lopinavir/
Ritonavir Safety and Activity in Treatment-naïve Patients
-
3/22/04
Activity
of Lopinavir, Amprenavir and Tipranavir Against HIV Type 1 Wild-type
and Drug-resistant Isolates 03/19/04
Double Protease Inhibitor Lopinavir/Ritonavir
Does Not Impair Drug Exposure of Saquinavir 03/19/04
Relationship
Between Lopinavir Concentration and Changes in Lipid Levels
-
2/25/04
Predictive
Factors of Hyperlipidemia in HIV Patients Receiving Lopinavar/Ritonavir
-
2/25/04
Synergistic
Activity of Lopinavir and Saquinavir on Protease Inhibitor-resistant
HIV -
2/25/04
The
Pharmacokinetic Interaction Between Lexiva and Kaletra -
2/13/04
Pharmacokinetics
and Safety of Kaletra Doses Greater than 300 mg/m2/ in Children
and Adolescents with HIV -
2/13/04
Predictive
Factors of Virological Success in PI-naive and -experienced HIV-infected
Children Treated with a Regimen Including Kaletra -
2/13/04
Lopinavir
Inhibitory Quotient Predicts Virologic Response in Highly Antiretroviral-experienced
Patients Receiving High-dose Kaletra -
2/13/04
Pharmacologic
Management of the Drug-Drug Interaction Between Kaletra and Agenerase
-
2/13/04
The
Effect of Reyataz vs Kaletra on Insulin-stimulated Glucose
Disposal Rate in Healthy Subjects 02/11/04
Lipid
Profiles of Patients Enrolled in the MaxCmin 2 Trial: Safety and
Efficacy of Lopinavir/Ritonavir 400/100 mg Twice Daily vs
Saquinavir/Ritonavir 1000/100 mg Twice Daily 02/11/04
Efficacy and Safety
of Reyataz (atazanavir) with Ritonavir or Saquinavir vs Lopinavir/Ritonavir
in Patients Who Have Experienced Virologic Failure on Multiple HAART
Regimens: 48-Week Results 02/09/04
Once-daily vs
Twice-daily Kaletra (lopinavir/ritonavir) in Treatment-naive
HIV Patients: 48-week Results 02/09/04
Pharmacologic Enhancement in
Protease Inhibitor-based HAART: The Role of Ritonavir
02/02/04
By Stephen L. Becker, MD, and Lorna Thornton, MD
Effect of Lopinavir on
Agenerase (amprenavir) Concentrations Boosted by Norvir (ritonavir)
01/23/04
Incidence
of Resistance in a Study Comparing Kaletra or Viracept Plus
Zerit and Epivir 01/14/04
Once-Daily Versus Twice-Daily
Kaletra (lopinavir/ritonavir) Among Treatment-naive HIV Patients
in a 48-week Trial 01/16/04
Real Life Effectiveness of ARV
Therapy Based on Kaletra Use in Treatment-Naïve Patients
with Advanced HIV Infection 12/01/03
Once Daily
Kaletra Vs Twice Daily Kaletra in Treatment-naïve Patients
11/03/03
Evaluation
of Pharmacokinetics of Kaletra in HIV-HCV Coinfected Patients
with Hepatic Insufficiency 11/03/03
Final Analysis
of Trial to Evaluate Safety and Efficacy of Lopinavir/Ritonavir
Versus Saquinavir/Ritonavir: MaxCmin 2 10/27/03
Characterizing
Evolution of Protease Inhibitor (PI) Resistance During Lopinavir/ritonavir
(LPV/r) Treatment and Study of the Salvage of Lopinavir Resistance
(SOKRATES Trials)
5-Year
Results of Lopinavir/ritonavir (LPV/r)-Based Therapy in Antiretroviral-Naïve
HIV-Infected Patients
Assessing
the Impact of Different Virologic Response Definitions on Response
Rates
Study
418: Efficacy and Safety of Once-daily Lopinavir/ritonavir vs.Twice-daily
Lopinavir/ritonavir in Antiretroviral-naive Patients: 24-Week Results
Gender,
Ethnic, and Geographic Associations with Quality of Life (QOL) in
Patients Before and After PI/NNRTI Substitution with Lopinavir/ritonavir
Evaluation
of the Multiple-Dose Pharmacokinetics of Lopinavir/Ritonavir (LPV/r)
in HIV and HCV Co-Infected Patients with Mild or Moderate Hepatic
Insufficiency
HIV-2-infected Patients Can Achieve
Sustained Viral Suppression Using a Regimen of 2 NRTIs and Boosted
Indinavir or Lopinavir 10/24/03
Interleukin-7 Levels May Predict
Virological Response in Advanced HIV Patients Receiving Kaletra-based
Therapy 10/20/03
Kaletra (lopinavir-ritonavir)
May Cause Opiate Withdrawal in Methadone-treated Patients 09/26/03
Pharmacokinetic
Drug Interaction and Long-term Safety Profile of Viread and Kaletra
09/24/03
Double
PI Salvage Regimen of Crixivan and Kaletra Without Nucleosides
May Yield Clinical Benefit 09/24/03
Safety
and Efficacy of Kaletra as Monotherapy in Treatment-naïve
HIV Patients 09/24/03
5-Year
Data on Kaletra (lopinavir/ritonavir) Shows Long-term Potency and
Tolerability 09/17/03
Gastrointestinal
Tolerability After PI/NNRTI Substitution with Lopinavir/ritonavir
PDF 09/17/03
Combining
GW433908 (Fosamprenavir; 908) With Lopinavir/Ritonavir (LPV/R)
In HIV-1 Infected Adults Results In Substantial Reductions In Amprenavir
(APV) and LPV Concentrations: Pharmacokinetic (PK) Results From
Adult ACTG Protocol A5143 09/17/03
Comparison
of the Effectiveness of Initial HAART Regimens 09/15/03
Lopinavir/ritonavir
in Antiretroviral-Naive HIV-Infected Patients: 5-Year Follow-Up
PDF
Evolution
of Lopinavir (LPV) Resistance in Protease Inhibitor-Experienced
Patients Treated with LPV/r
PDF
Virological Success of Kaletra
(lopinavir/ritonavir) Salvage Regimen Is Affected by an Increasing
Number of lopinavir/ritonavir-related Mutations 08/29/03
Patients Achieving
Highe Lopinavir Plasma Concentrations During Salvage Therapy May
Be at Greater Risk of Experiencing Dyslipidemia 08/15/03
Combination of Kaletra
(lopinavir/ritonavir) Plus Fortovase (saquinavir) Shows Benefits
in Salvage Therapy 08/06/03
Lipid Levels
in Treatment-experienced Patients Improve Following Switch to Reyataz
(atazanavir)
07/30/03
SOKRATES:
Prospective Evaluation of Resistance in Protease During
Lopinavir/ritonavir Treatment
B daSilva and others. Abstract 779. 2nd IAS Conference,
Paris. 2003.
CD4 Cell Increases Through
More Than 4 Years •in Antiretroviral-Naïve
HIV+ Patients Treated with Lopinavir/ritonavir-Based Therapy
H Kessler and others. Abstract 568. 2nd IAS Conference,
Paris. 2003.
Assesment
of Depression in Patients After Substitution of Their PI/NNRTI with
Lopinavir/Ritonavir
J
Rockstroh and others. Abstract 549. 2nd IAS Conference,
Paris. 2003.
Evaluation
of Side Effect in Patients After Substitution of Their PI/NNRTI
with Lopinavir/Ritonavir
D
Bassetti and others. Abstract 106. 2nd IAS Conference,
Paris. 2003.
Within
Patient Variance Reduced in an ARV PK Study by Switching from Patient-Reported
to Electronically Monitored Dosing Times
B
Vrijens and others. Abstract 846. 2nd IAS Conference,
Paris. 2003.
Multiple
Dose Pharmacokinetics and Initial Antiviral Effect of Once Daily
lopinavir/Ritonavir (LPV/r) in Combination with Tenofovir (TDF)
and emtricitabine (FTC) in HIV-Infected Antiretroviral-Naïve Subjects
(Study 418)
Y-L
Chiu and others. Abstract 839. 2nd IAS Conference, Paris.
2003.
Virological
and Pharmacological Parameters Predicting the Response to
Lopinavir/ritonavir
AG Marcelin and others. Abstract 827. 2nd IAS Conference,
Paris. 2003.
Steady-State
Pharmacokinetics and Short-Term Virologic Response of Two
Lopinavir/ritonavir (LPV/r) High-Dose Regimens in Multiple Antiretroviral-
Experienced Subjects (Study 049)
C Flexner and others. Abstract 843. 2nd IAS Conference,
Paris. 2003.
Relationship
Between Adherence and the Development of Viral Resistance in
Antiretroviral-Naive Patients Treated with Lopinavir/ritonavir (LPV/r)
or Nelfinavir (NFV)
M King and others. Abstract 798. 2nd IAS Conference,
Paris. 2003.
Second-generation
PI 908 Shows Mixed Results in Final Trial 07/28/03
In Salvage Therapy, Best Use of
Kaletra (lopinavir/ritonavir) May Be for Patients with <
5 PI Mutations and the Presence of Mutation 54 07/28/03
Evaluation
of Resistance Patterns in PI-based Therapy with Kaletra 07/28/03
Ritonavir-boosted Reyataz (atazanavir)
Regimen Produces HIV Viral Load Decrease Comparable to Kaletra
(lopinavir/ritonavir) Regimen at 24 Weeks
07/16/03
Kaletra (lopinavir/ritonavir)
Is Most-prescribed Protease Inhibitor in US and Europe for Treatment
of HIV -
06/25/03
Cross Resistance Between Kaletra
(lopinavir) and Agenerase (amprenavir) Is More Common Than Expected
-
04/21/03
Kaletra
Is Highly Effective in Children -
03/17/03
Increased
Tolerance and Effectiveness Against Highly-Resistant HIV Explain
Why Kaletra (Lopinavir/Ritonavir) Out-Performs Other Norvir-Boosted
Regimens
-
01/06/03
Pharmacokinetic/Pharmacodynamic
Modeling of HIV Therapy -
11/20/02
Timing
Error Analysis of Data on Adherence to Lopinavir/Ritonavir
Provides Superior Explanatory Power for Virologic Response
-
11/20/02
CD4/CD8
Subset Analysis in Antiretroviral-Naïve HIV+ Patients Receiving
Lopinavir/ritonavir (Kaletra)
-
11/20/02
Improved Tolerability and Quality
of Life in Subjects Receiving Kaletra (Lopinavir/Ritonavir)
-
11/20/02
Cross-Resistance
Mutation Patterns Differ for Agenerase (Amprenavir) and Kaletra
(Lopinavir) -
10/28/02
Abbott
Announces Kaletra (Lopinavir/Ritonavir) Is Most Prescribed
PI in the US -
10/04/02
Abbott
PI Kaletra Shows No Resistance in 4-Year Study
-
09/30/02
Salvage
Treatment with Kaletra (Lopinavir/Ritonavir) Is Effective
in Many HIV patients Failing All Available HIV Drugs
-
09/09/02
Bradyarrhythmia
Seen in Two HIV Patients Beginning Kaletra (Lopinavir/Ritonavir)
-
09/09/02
Kaletra
Exhibits Sustained Virologic Response in Antiretroviral-Naïve Patients:
3-Year Data
-
07/15/02
Lopinavir/Ritonavir
Outperforms Nelfinavir as Initial Treatment for HIV Infection
-
06/28/02
Agenerase
Mutations May Significantly Impact Kaletra Resistance
-
04/26/02
Increased
Doses of Both Agenerase and Kaletra Are Required if Dosed
Concomitantly -
04/08/02
Kaletra
(lopinavir/ritonavir) May Be Effective in Protease Inhibitor-Experienced
HIV Patients -
03/13/02
Abstracts
Presented at ICAAC on the Protease Inhibitor Kaletra (Lopinavir/Ritonavir)
-
12/22/01
Kaletra
(Lopinavir/Ritonavir) Therapy in Single Protease Inhibitor Experienced
Patients: 144 Week Follow Up
11/21/01
Kaletra
in Antiretroviral Naïve HIV Positive Patients: 3-Year Follow Up
11/21/01
Kaletra
Effective in Naïve Patients After Three Years of Treatment
11/05/01
Kaletra: Durable at 144 Weeks
of Follow Up
7/27/01
Early
Failure of a Kaletra Regimen is Unlikely to be Related to
Protease Mutations
7/23/01
Kaletra
Superior to Nelfinavir in Antiretroviral-Naïve Patients
7/11/01
Most
Patients Failing Initial HIV Protease Inhibitor Therapy May Respond
to Kaletra
7/04/01
Some
Mutations Have Higher Predictive Value Regarding Kaletra
Resistance
6/29/01
French
Study Confirms Kaletra Genotypic Breakpoints
6/25/01
FDA
Posts New Safety-Related Drug Labeling Changes for Kaletra
4/30/01
Update
on HIV Drug Resistance from the 8th Conference on Retroviruses and
Opportunistic Infections: Part I
2/14/01
48-Week
Report on Multiple Protease Inhibitor-Experienced Patients Treated
with Kaletra Plus Sustiva
2/08/01
Kaletra
(Lopinavir/Ritonavir): A New Generation of Protease Inhibitor
12/20/00
Recently-Approved Protease
Inhibitor Kaletra Shows Potent Anti-HIV Effect
11/20/00
Kaletra
(lopinavir; ABT-378/ritonavir) Versus Viracept (nelfinavir)
10/24/00
Recent
Reports Reaffirm the Effectiveness and Tolerability of New PI Kaletra
Plus Sustiva and Kaletra Plus Zerit and Epivir
10/02/00
FDA Grants Accelerated Approval
to New HIV Protease Inhibitor Kaletra
9/18/00
Kaletra plus Sustiva
and 2 NRTI Drugs in HIV Patients with Multiple Prior PI Drugs: 24-Week
Results
8/25/00
Kaletra plus Viramune
and 2 NRTI Drugs for HIV after "Failing" One Prior PI Drug: 72-Week
Results
8/25/00
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