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Invirase (Saquinavir Mesylate) - Summary

 

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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.

INVIRASE NEWS HIGHLIGHTS

Media Articles Related to Invirase (Saquinavir)

Scientists Spot New Twist in HIV Infection (HealthDay)
Source: Y! Health News Search RSS Feed [2008.09.04]

CDC Report On New HIV Infections In U.S. Did Not Include Data From Puerto Rico; Omission Has Widespread Consequences, Advocates Say
Source: HIV / AIDS News From Medical News Today [2008.09.03]

In NYC, new HIV infections 3 times national rate (AP)
Source: Y! Health HIV & AIDS News [2008.08.27]

Number of New U.S. HIV Infections Gets Revised Upward
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2008.08.04]

Herpes Suppression May Not Prevent HIV Infection
Source: MedicineNet Genital Herpes In Women Specialty [2008.06.20]

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Published Studies Related to Invirase (Saquinavir)

Pharmacokinetics and safety of saquinavir/ritonavir and omeprazole in HIV-infected subjects. [2008.06]

Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir. [2008]

Viral Decay Dynamics in HIV-Infected Patients Receiving Ritonavir-Boosted Saquinavir and Efavirenz With or Without Enfuvirtide: A Randomized, Controlled Trial (HIV-NAT 012). [2006.11.01]

Variation in oral clearance of saquinavir is predicted by CYP3A5*1 genotype but not by enterocyte content of cytochrome P450 3A5. [2005.12]

Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. [2005.04.29]

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Clinical Trials Related to Invirase (Saquinavir)

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]

The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year [Completed]

Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment [Active, not recruiting]

Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC [Completed]

A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients [Completed]

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Page last updated: 2008-09-04

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