INVIRASE SUMMARY
INVIRASE® (saquinavir mesylate) CAPSULES and TABLETS
INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus (HIV) protease. INVIRASE is available as light brown and green, opaque hard gelatin capsules for oral administration in a 200-mg strength (as saquinavir free base).
INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 study (see Table 7) and pharmacokinetic data (see Table 1). The efficacy of INVIRASE with ritonavir or FORTOVASE (with or without ritonavir coadministration) has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.
In a randomized, double-blind clinical study (NV14256) in ZDV-experienced, HIV-infected patients, INVIRASE in combination with HIVID was shown to be superior to either INVIRASE or HIVID monotherapy in decreasing the cumulative incidence of clinical disease progression to AIDS-defining events or death. Furthermore, in a randomized study (ACTG229/NV14255), patients with advanced HIV infection with history of prolonged ZDV treatment and who were given INVIRASE 600 mg tid + ZDV + HIVID experienced greater increases in CD4 cell counts as compared to those who received INVIRASE + ZDV or HIVID + ZDV. It should be noted that HIV treatment regimens that were used in these initial clinical studies of INVIRASE are no longer considered standard of care.
FORTOVASE 1000 mg bid coadministered with ritonavir 100 mg bid was studied in a heterogeneous population of 148 HIV-infected patients (MaxCmin 1 study). At baseline 42 were treatment na[iuml ]ve and 106 were treatment experienced (of which 52 had an HIV RNA level <400 copies/mL at baseline). Results showed that 91/148 (61%) subjects achieved and/or sustained an HIV RNA level <400 copies/mL at the completion of 48 weeks.
|
NEWS HIGHLIGHTSMedia Articles Related to Invirase (Saquinavir)
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Invirase (Saquinavir)
Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers. [2011]
Tenofovir disoproxil fumarate (TDF, CAS 147127-20-6) is a nucleotide reverse transcriptase inhibitor which is indicated in combination with other antiretroviral agents for the management of HIV-1 infection. The objective of this study was to compare the rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing 300 mg of TDF and the innovator product...
Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy in long-term virologically suppressed HIV-infected patients. [2010.09.01]
BACKGROUND: The high antiviral potency and low toxicity of saquinavir/ritonavir (SQV/r) prompted us to assess a viable strategy in chronic virologically suppressed HIV-infected patients... CONCLUSION: SQV/r as monotherapy has proven to be a valid, safe, and economical option for virologically suppressed HIV-infected patients, especially in those who experience intolerance or toxicity with nucleoside analogs.
Gemini: a noninferiority study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. [2009.04.01]
INTRODUCTION:: Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients... CONCLUSIONS:: In treatment-naive, HIV-1-infected patients, SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile.
Pharmacokinetics and safety of saquinavir/ritonavir and omeprazole in HIV-infected subjects. [2008.06]
We investigated the pharmacokinetics and safety of saquinavir/ritonavir when administered with omeprazole simultaneously and 2 h apart to human immunodeficiency virus (HIV) subjects. Saquinavir/ritonavir 12-h pharmacokinetics was assessed with and without omeprazole 40 mg... In the presence of omeprazole, saquinavir plasma exposure is significantly increased in HIV-infected subjects whether administered simultaneously or 2 h apart.
Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir. [2008]
BACKGROUND: The aim of this study was to assess the long-term efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors (NRTIs)... CONCLUSION: First-line highly active antiretroviral therapy with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy.
Clinical Trials Related to Invirase (Saquinavir)
Bioequivalence Study of Generic GPO Saquinavir and NorvirŽ Versus InviraseŽ and NorvirŽ [Not yet recruiting]
The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this
study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether
the generic GPO saquinavir shows bioequivalence when boosted with NorvirŽ. If the generic
formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.
Lopinavir Capsules to Kaletra or Invirase Tablets [Recruiting]
This study will compare the benefit for patients switching from KaletraŽ to InviraseŽ
tablets over remaining on KaletraŽ (based on randomization), to elicit the lipid benefits
inferred in previous studies
A 48-Week, Randomised, Study to Describe the Pharmacokinetic Profile and Durability of Atazanavir-Saquinavir-Ritonavir Once Daily and Describe the Pharmacokinetic Profile of Saquinavir-Ritonavir Using Saquinavir 500mg Formulation: the ASK-500 Study [Active, not recruiting]
Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease.
Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on
saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of
pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study
will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii)
blood drug levels in individuals taking both saquinavir formulations when given with
atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir
formulation with atazanavir as HIV therapy.
The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year [Completed]
To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule
formulation of saquinavir or to indinavir following prolonged use of the original hard
capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.
Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have
shown that cross-resistance occurs among protease inhibitors, although no clinical trials
have been conducted to examine antiretroviral activity with sequential use of protease
inhibitors or to determine whether saquinavir resistance can be overcome with higher
concentrations of the drug.
Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment [Active, not recruiting]
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance
therapy, compared to standard HAART therapies.
Reports of Suspected Invirase (Saquinavir) Side Effects
Hypospadias (7),
Maternal Exposure Timing Unspecified (6),
Maternal Exposure During Pregnancy (5),
Hepatic Function Abnormal (4),
Cardiac Failure (4),
Pulmonary Hypertension (3),
Infection (3),
Palpitations (3),
Dizziness (3),
Penile Curvature (3), more >>
|
