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Roche
Gains European Approval for More Potent Formulation of Saquinavir
Roche Pharmaceuticals has received European approval for the more
potent formulation of its saquinavir
(Invirase) tablet to treat HIV, according to an announcement
by the Swiss drug maker last week.
The
European Commission approved Invirase
in a 500 mg formulation, thus cutting the daily pill requirement
from five to two, Roche said in a statement.
Invirase
500 mg received U.S. Food and Drug Administration (FDA) approval
last December.
Earlier
this month, Roche said that in early 2006 the company would withdraw
from the market its soft-gel
formulation of saquinavir (Fortovase)
because demand for that drug has declined and because the hard-gel
saquinavir formulation (Invirase) in combination with low dose ritonavir
(Norvir) provided more potency and convenience than Fortovase.
Invirase,
which is not among Roche’s top 20 products, was launched in 1995
and was the first HIV protease inhibitor on the market.
06/01/05
Fortovase
Product Information
(31-page
PDF File) 
Invirase
Product Information
(6-page
PDF File)
Additional Articles on Fortovase / Invirase
(Saquinavir)
In
Early 2006 Roche Will Voluntarily Discontinue Sale and Distribution
of HIV Protease Inhibitor (PI) Fortovase
-
5/20/05
Boosted
Saquinavir Hard-gel (Invirase) Formulation Exposure in HIV
Patients: Ritonavir 100 mg Once Daily Versus Twice Daily
-
3/07/05
Roche
Issues Drug Interaction Warning on Hepatocellular Toxicity in Healthy
Volunteers Receiving TB Drug Rifampin and Saquinavir/Ritonavir
-
2/09/05
Short-course
Induction with Boosted Saquinavir Monotherapy for Naive Patients
with Late-stage Infection -
1/28/05
Hepatotoxicity
Associated with Protease inhibitor-based Regimens with or without
Concurrent Ritonavir
- 1/05/05
Complementary
and Alternative Medicine Use Is Common Among HIV Positive Women
-
12/06/04
Intracellular
Accumulation of PIs Occurs But Mechanism Is Unclear
- 11/22/04
Simultaneous
Administration of Saquinavir Hard Gel and Ritonavir Is Required
for Optimal SQV Absorption -
11/01/04
Steady-State
Pharmacokinetics of Saquinavir Hard-Gel/Ritonavir/Fosamprenavir
in HIV Patients - 10/20/04
Analysis
of Failure Rates in a Study of Resistance Profiles and Adherence
in Three Different HAART Regimens -
09/24/04
Taking
the Convenience of Once-daily Dosing into Consideration, Saquinavir/Ritonavir
2000/100 mg Once-daily May Be the Peferred Dosing Regimen -
09/08/04
Sex-related
Differences in the Pharmacokinetics of Once Daily Saquinavir
Boosted with Low-dose Ritonavir -
09/01/04
FDA
Gives Priority Review Status to Roche's New Formulation of Invirase
-
08/18/04
At
24 Weeks a Once-daily Regimen of Saquinavir/Ritonavir with
Two NRTIs Is as Effective as a Twice-daily Regimen of Indinavir/Ritonavir
with Two NRTIs -
08/16/04
Lopinavir/Ritonavir
and Saquinavir Hard Gel Combination Is an Effective Alternative
HAART Regimen -
07/21/04
New
Data on Boosted Saquinavir Demonstrate Undetectable Viral
Load in 91% of Patients -
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
Roche
Submits New Invirase Application to FDA - 06/23/04
No
Dosage Adjustments Necessary when Enfuvirtide Is Co-administered
with Low-dose Ritonavir or Saquinavir Boosted with a Low
Dose of Ritonavir -
06/21/04
Atazanavir
Enhances Saquinavir Hard-gel Concentrations in a Ritonavir-boosted
Once-daily Regimen - 05/28/04
Once
Daily Dosing of Saquinavir Soft-gel Capsules and Ritonavir
Combination -
05/21/04
Pharmacokinetics
of Tenofovir DF in HIV Patients Receiving Saquinavir Hard
Gel/Ritonavir 1000/100 mg Twice Daily 04/14/04
Sex-Based
Differences in Saquinavir Pharmacology and Virologic Response
in ACTG Study 359 -
3/29/04
Once-daily
Saquinavir and Ritonavir in Treatment-experienced HIV-infected
Individuals -
3/29/04
Double
Protease Inhibitor Lopinavir/Ritonavir Does Not Impair Drug Exposure
of Saquinavir 03/19/04
Pharmacokinetics
of Saquinavir Plus Low-dose Ritonavir in HIV Positive Pregnant
Women 03/10/04
The
Effects of Once-daily Saquinavir/Low-dose Ritonavir on the
Pharmacokinetics of Methadone 03/10/04
Once-daily
Saquinavir/ Ritonavir Shows Considerable Short-term Virologic
Activity in Treatment-experienced HIV Patients 03/10/04
Oral
Contraception Does Not Alter Single Dose Saquinavir Pharmacokinetics
in Women 03/10/04
Enhanced Saquinavir
(Invirase) Exposure in HIV Patients with Diarrhea and/or Wasting
Syndrome -3/10/04
Pharmacokinetics
of Saquinavir Plus Low-dose Ritonavir in HIV Positive Pregnant
Women 03/10/04
Saquinavir Useful in HIV
Patients with Gastrointestinal Problems 3/04/04
Synergistic
Activity of Lopinavir and Saquinavir on Protease Inhibitor-resistant
HIV -
2/25/04
Reyataz
Enhances Invirase Concentrations in a Norvir-boosted Once
Daily Regimen 02/11/04
Steady
State Pharmacokinetics of Invirase/Lexiva 1000/700 mg Plus
100 mg and 200 mg of Norvir Twice Daily 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
Enhanced Saquinavir Exposure
in HIV Patients with Diarrhea and/or Wasting Syndrome 02/04/04
Saquinavir-Ritonavir Dual PI
Regimen at 800/100 mg B.I.D. Is a Reasonable Treatment Option for
HIV Positive Pregnant Women 02/04/04
FDA Approves Roche Protease
Inhibitor Invirase Boosted with Norvir
01/07/04
Therapeutic
Dose of Protease Inhbitor Saquinavir Does Not Permanently Influence
Early Insulin Signaling 01/14/04
A randomized clinical trial to
compare the effectiveness of indinavir, ritonavir and saquinavir.
11/10/03
Pharmacokinetics
(PK) of Saquinavir/Ritonavir (SQV/R) once daily (OD) in HIV
Patients Compared with Standard Regimens 10/31/03
Final
Analysis of Trial to Evaluate Safety and Efficacy of Lopinavir/Ritonavir
Versus Saquinavir/Ritonavir: MaxCmin 2 10/27/03
Once-daily
Therapy with Saquinavir/Ritonavir Combination 1600/100mg
in HIV Treatment-naïve Patients 10/27/03
Pharmacokinetic
Study of Saquinavir/Ritonavir 1600/100mg QD Compared to 2000/100
QD and 1000/100mg BID 10/27/03
Pharmacokinetics
in Randomized Trial to Evaluate Safety and Efficacy of indinavir/ritonavir
800/100mg BID Versus Saquinavir/Ritonavir 1000/100mg BID:
The MaxCmin 1 trial 10/27/03
Prevalence
of Lipodystrophy and Retinoid Syndrome in the MaxCmin 1 Trial Evaluating
Safety and Efficacy of Indinavir/Ritonavir Vs Saquinavir/Ritonavir
10/27/03
Saquinavir/Ritonavir
(SQV/r) Pharmacokinetics in HIV Patients: 1000/100mg Twice Daily
vs 1600/100 and 2000/100mg Once Daily
09/15/03
Predictive
Value of Drug Levels, HIV Genotyping, and the Genotypic Inhibitory
Quotient (GIQ) at Different Time-Points Along 48 Weeks Using A SQV/RTV
Salvage Therapy
PDF
09/15/03
Evaluation of Indinavir/Ritonavir
Versus Saquinavir/Ritonavir in HIV Patients: The MaxCmin-1
Trial
09/10/03
Ritonavir-boosted
Saquinavir Shows Equivalent Efficacy and More Favorable Toxicity
Profile Compared to Ritonavir-boosted Indinavir: The MaxCmin-1 Trial
08/25/03
Combination
of Kaletra (lopinavir/ritonavir) Plus Fortovase (saquinavir)
Shows Benefits in Salvage Therapy
08/06/03
Effect of Simultaneous Versus Staggered
Dosing on Pharmacokinetic Interactions of Protease Inhibitors
08/04/03
Saquinavir
500 mg tablet, a new formulation, has similar bioavailability to
Invirase 200 mg capsule for healthy volunteers at 1000/100 mg BID
dosing with ritonavir
07/25/03
The
final week 48 of a phase IV randomized, open-label, multi-centre
trial to evaluate safety and efficacy of lopinavir/ritonavir (400/100
mg bid) versus saquinavir/ritonavir (1000/100 bid) in adult
HIV-1 infection: the MaxCmin2 trial
M
Youle and others. Abstract LB 23. 2nd IAS Conference.
Paris, 2003.
07/25/03
The
LOPSAQ Study: 24-week analysis of the double protease inhibitor
PI salvage regimen containing lopinavir (LPV/r) plus saquinavir
(SQV) without any additional antiretroviral therapy (ART)
S
Staszewski and others. Abstract 583. 2nd IAS Conference.
Paris, 2003.
07/25/03
A
pilot study of saquinavir-sgc (SQV) and lopinavir/ritonavir
(LPV/r) twice daily in protease inhibitor (PI)-naïve HIV-positive
individuals: protease inhibitor concentrations and week 48 results
J
Hellinger and others. Abstract 571. 2nd IAS Conference.
Paris, 2003.
07/25/03
Efficiency,
security for saquinavir 1600 mg/ritonavir 100 mg QD plus
two nucleoside analogues in HIV+ naïve patients (preliminary results)
J
González-García and others. Abstract 565. 2nd IAS Conference. Paris,
2003.
07/25/03
Pharmacokinetics
(PK) of saquinavir-hard gel capsules (SQV-hgc) when combined
with atazanavir (ATV) as once a day combination (1200/400) in highly
experienced HIV-positive patients
E Seminari and others. Abstract 847. 2nd IAS Conference. Paris, 2003.
07/25/03
Clinically
relevant interpretation of genotype for resistance to saquinavir
(800 mg bid) plus ritonavir (100 mg bid) in HIV-1 infected protease
inhibitor experienced patients
AG
Marcelin and others. Abstract 826. 2nd IAS Conference. Paris,
2003.
07/25/03
Phase
IV clinical trial to access the efficacy and safety of antiretroviral
treatment with ritonavir and saquinavir (400mg-400mg) concomitant
with rifampicin in tuberculosis and AIDS patients
V
Rolla and others. Abstract 882. 2nd IAS Conference. Paris,
2003.
07/25/03
Fortogene
Mexico: 24-week report: clinical utility of saquinavir soft gel
capsules (Fortovase) in combination with HIV genotyping in
Mexican patients
L
Nieto and others. Abstract 789. 2nd IAS Conference. Paris,
2003.
07/25/03
The MaxCmin 1 trial data (see below) were presented at the
5th Lipodystrophy Workshop held in Paris just
prior to the 2nd IAS Conference).
Hepatotoxicity
of ritonavir-boosted indinavir (800/100mg twice daily) and saquinavir
(1000/100 mg twice daily, in a phase IV, randomized, open-label
and multicentre trial in adult HIV-1 infection: the MaxCmin1 trial
D Lundgen and
others. Abstract 126. 5th International Workshop on
Adverse Drug Reactions and Lipodystrophy in HIV. July 9-11,
2003. Paris, France.
07/25/03
Sustiva
(Efavirenz) Outperforms Fortovase (Saquinavir) + Norvir (Ritonavir)
Dosed Once Daily
07/25/03
Study
Examines Lipid Safety Profile of Norvir (Ritonavir) Boosted Fortovase
(Saquinavir) vs. Norvir Boosted Crixivan (Indinavir)
10/02/02
Saquinavir-Ritonavir
Combination for HIV Therapy Gets European Approval
09/20/02
Fortovase
(Saquinavir) Plus Nucleoside Is a Safe Method of Preventing
Vertical Transmission of HIV
08/14/02
Comparable Efficacy in BID Crixivan
(Indinavir) or BID Fortovase (Saquinavir) Plus Norvir (Ritonavir)
but More Serious Adverse Events in Crixivan Arm: The MaxCmin1 trial
07/19/02
Once-daily Saquinavir/Ritonavir
(Fortovase/Norvir) Effective in Maintaining HIV Suppression
05/29/02
Fortovase
Switch to Once-Daily Therapy Appears Safe and Effective
04/24/02
Saquinavir Is Suboptimal
in HIV-Positive Children Unless Combined with Other PIs
04/22/02
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