One Pill, Once Daily: Now an Option for HIV Patients

News in Context |
July 31, 2006

One Pill, Once Daily: Now an Option for HIV Patients

  1. Paul E. Sax, MD

The new (and long-awaited) tenofovir/FTC/efavirenz coformulation should be an effective option for treatment-naive patients, as well as for some treatment-experienced patients who want to reduce their pill burden.

  1. Paul E. Sax, MD

On July 12, 2006, the FDA approved the first one-pill, once-daily regimen for HIV treatment, a coformulated tablet containing tenofovir, FTC, and efavirenz. Sold under the brand name Atripla, the coformulation represents a major advance in HIV treatment for several reasons:

  • The regimen contained in the tablet is one of the most effective antiretroviral combinations currently available for treatment-naive patients, as evidenced by its inclusion as a “preferred NNRTI-based regimen” in the latest DHHS treatment guidelines. Results from a recent randomized trial confirmed the regimen’s superiority over AZT/3TC + efavirenz (ACC Feb 1 2006).

  • Patient surveys repeatedly show a strong preference for fewer pills per day.

  • The tablet is the result of a cooperative effort between two pharmaceutical companies. Such collaboration is unprecedented in HIV treatment and will hopefully be a harbinger for more development along these lines.

  • The 30-day cost of tenofovir/FTC/efavirenz (US$1150) is comparable to the cost of purchasing tenofovir/FTC and efavirenz separately. In addition, many insurance companies may charge only one co-pay, as they have done for other coformulated HIV treatments such as lopinavir/ritonavir, tenofovir/FTC, abacavir/3TC, AZT/3TC, and AZT/3TC/abacavir.

Given these advantages, tenofovir/FTC/efavirenz should be strongly considered for treatment-naive patients beginning their first regimen. Depending on treatment history, it is also a potential switch option for some treatment-experienced patients who are interested in a lower pill burden. However, the coformulation will not be appropriate for certain patients who have relative or absolute contraindications to individual components of the tablet. These patients include women who might become pregnant (efavirenz is a Pregnancy Category D drug), patients with renal insufficiency (tenofovir has potentially nephrotoxic effects), and patients with NNRTI resistance as a result of prior treatment or acquisition of resistant virus.

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