New Treatment Guidelines
Posted on June 23, 2014 by A&U in LifeGuide, Treatment Horizons
LifeGuide
[Treatment Horizons]
New Guidelines
Revised treatment strategies address cost, monitoring & choosing a regimen
by Chael Needle
Revised guidelines for HIV treatment approaches will help you and your physician figure out how to fine-tune your regimen, now or when you might need to do so in the future. Reported in Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, which was developed by a panel of experts under the direction of the U.S. Department of Health and Human Services and its Office of AIDS Research, the information seeks to incorporate new insights about antiretroviral treatment for HIV based on the latest research and update the shifts in gold-standard HIV care practice.
The following sections reflect the major new revisions and updates in the guidelines:
Cost Considerations & Antiretroviral Therapy
This new section breaks from tradition by adding an overview of antiretroviral therapy-related costs to the guidelines. Discussing costs in the context of adherence, the new section covers cost-sharing, prior authorizations, and the use of generic drugs.
The new section also makes special note of strategies that may contain costs, without threatening treatment efficacy.
Laboratory monitoring. As research suggests that continued CD4 monitoring does not change positive health outcomes for patients with viral suppression and CD4 counts exceeding 200 cells/mm3 after 48 weeks of therapy, the panel recommends that patients with long-term virologic suppression on ART be switched from biannual to annual monitoring.
Generic formulations. Though the panel recognizes the potential of increased pill burden and reduced adherence with the use of generics, it provides comprehensive tables that show average monthly wholesale generic drug prices to be lower than brand-name prices, and thus a potential cost-saving strategy.
Navigating payment. The panel recommends that healthcare providers stay up-to-date about current insurance and payment structures, ART costs, discounts among preferred pharmacies, and available generic options, as well as work with patients (and their case managers and social workers) to become aware of the particulars of their pharmacy benefit plans and any potential financial barriers to filling their prescriptions.
Familiarization with other cost-saving options, such as ADAP and pharmaceutical company patient assistance programs, is also recommended.
Frequency of CD4 Count Monitoring
The panel recommends a decrease in CD4 count monitoring, while maintaining the importance of viral load as a marker of treatment success. The panel reaffirms the importance of frequent CD4 count monitoring when a patient first enters care to determine the need for initializing antiretrovirals and prophylaxis against any opportunistic infections; or when a patient experiences viral rebound, develops new HIV-associated clinical symptoms, or develops conditions or starts therapy that may lead to a depletion of CD4 cells. Monitoring is also helpful in patients with advanced HIV infection to indicate when OI prophylaxis or treatment might be discontinued.
However, frequent CD4 count monitoring is generally not needed for patient management, especially in patients with higher counts and consistently suppressed viral loads, as previously noted.
“Preferred Regimens” vs. “Recommended Regimens” for Initial Treatment
As options for initial therapy for treatment-naive patients have expanded since 2009, the panel has changed “preferred”—which singled out four regimens—to “recommended,” which accounts for new agents and co-formulated products that have proven to be efficacious in long-term follow-up studies and clinical practice. Recognized for their optimal and durable virologic efficacy, favorable tolerability and toxicity profiles, and ease of use, these regimens are further classified according to a patient’s baseline viral load and CD4 cell count.
The list of alternative regimens has also been revised, with the panel noting that, depending on the individual patient, an alternative may be an optimal therapy. Overall, though, these alternatives are effective and tolerable, but may have possible drawbacks and less supportive research data when compared to those labeled “recommended.” Some drugs have now fallen off the recommended list in light of new, expanded options.
Switching ARV Drugs While Virally Suppressed
Switching regimens should always maintain viral suppression without closing off future treatment options and be done in accordance with a patient’s prior treatment history and responses to ART, resistance profiles, and drug tolerance, the panel recommends. The report also provides data from clinical trials that have studied switching from traditional to alternative regimens, and a new table outlines recommendations for switching because of adverse effects from drugs.
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To read the report on revised guidelines, log on to: http://aidsinfo.nih.gov/guidelines.
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Chael Needle wrote about mood fluctuations in relation to protective practices among HIV-positive MSM in last month’s Wellness Watch.
