HIV JournalView

Table of Contents

• It's Official: Once-Daily Atazanavir Effective in Naive Patients
• High Success for Sperm Washing in Preventing HIV, Hepatitis C
• Long-Term Resistance Patterns on Enfuvirtide
• Primary Drug Resistance Can Persist a Year or More
• Many Patients Remain Stable Despite Persistent Low-Level Viremia
• Using Suction-Assisted Lipectomy to Treat Buffalo Hump
• Exogenous Growth Hormone, an Expensive (and Questionable) Fat Accumulation Treatment
• References

It's Official: Once-Daily Atazanavir Effective in Naive Patients

Squires K, Lazzarin A, Gatell JM, et al. Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Defic Syndr. August 15, 2004;36(5):1011-1019.

It's always good to see the publication of data that led to the approval of an HIV medication. This paper presents data from one of the major studies that led to the U.S. Food and Drug Administration's approval of the HIV-1 protease inhibitor (PI) atazanavir (ATV, Reyataz) on June 23, 2003.

This was an international, randomized, double-blind, 2-arm, comparative study in treatment-naive patients. The 2 arms of the study were efavirenz (EFV, Sustiva, Stocrin) 600 mg or atazanavir 400 mg given orally once daily plus fixed-dose zidovudine/lamivudine (AZT/3TC, Combivir) given orally twice daily for 48 weeks. The primary endpoint was the number of treated patients who achieved a plasma viral load < 400 copies/mL at 48 weeks. The secondary endpoint was the number of patients who achieved a plasma viral load < 50 copies/mL at 48 weeks. Patients were stratified 1:1 by baseline viral load (< 30,000 vs. > 30,000 copies/mL). Safety, tolerability and toxicity were also monitored throughout the study.

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