Late 2004 Changes to Federal (DHHS) Treatment Guidelines
PHS Panel Embraces Treatment Interruption
"[Single episode treatment interruption] may be offered to patients with immune reconstitution, although participation in a controlled trial would be preferred. ... The long-term safety and efficacy of this approach are not known."
Source: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, US DHHS. Updated 10/29/04.
Viral load threshold for initiating antiretroviral therapy in asymptomatic individuals with CD4 count >350
Recommendations for interrupting treatment in individuals with relatively successful viral control
There was none -- except to warn against it.
A full page and a half of considerations, evidence (and warnings against the lack thereof). "This option (treatment interruption and reinstitution based on CD4 cell count) may be offered to patients with immune reconstitution, although participation in a controlled trial would be preferred. The long-term safety and efficacy of this approach, however, are not known."
Coming to terms with stavudine (d4T/Zerit)'s association with lipoatrophy (especially facial) and other side effects
Stavudine (d4T/Zerit) was listed among "preferred" components of first-line therapy.
Stavudine (d4T/Zerit) has been sidelined from "preferred" to "alternative" nuke option.
(Comment: Now in line with British HIV Association (BHIVA) guidelines, albeit 2 years later.)
Coming to terms with Trizivir (AZT/3TC/ABC)'s lack of efficacy
Should only be used where other options may be less desirable due to concerns over toxicities, drug interactions, or regimen complexity.
Not to use except when no other acceptable regimens for patient.
Recommendations for adjunctive use of hydroxyurea
"Should not be offered at any time."
Something along the lines of, "Not within our purview" (a.k.a. "too hot a potato for our hands") Okay, in the august panel's trenchant prose: "It is the opinion of the Panel that discussions in the guidelines should limit themselves to commentary on FDA-approved agents that are indicated for the treatment of HIV infection ... and thus [hydroxyurea] will not be discussed in this guidelines document."
(Comment: Guidelines writing as an Olympic sport! Some sort of acrobatics award is clearly in order here.)
Resistance testing in individuals on treatment
Only results from testing done while patient still actively taking the drugs in question are meaningful.
Resistance testing can be successfully performed on blood samples drawn within 4 weeks of drug discontinuation (of drugs in question).
Baseline resistance testing for drug naive chronically infected individuals considering starting antiretroviral therapy
"It may be reasonable to consider such testing, however ..."
Baseline resistance testing recommended.
Source: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, US Department of Health and Human Services (DHHS). Updated October 29, 2004.