mental health AIDS

Fall 2006 Newsletter / Volume 8, Issue 1

HIV Treatment News

Medical Care

The U.S. Food and Drug Administration (FDA) recently announced two new antiretroviral treatment options:

  o On June 23, the FDA approved Prezista™ (darunavir, formerly known as TMC-114) for use with treatment-experienced adults who have developed resistance to first-line antiretrovirals. "Prezista, a protease inhibitor, is indicated to be co-administered with a low-dose of ritonavir [Norvir®], in combination with other active anti-HIV agents. Ritonavir, which is also a protease inhibitor, slows the metabolism of Prezista, resulting in increased plasma concentrations. The recommended oral dose of Prezista tablets is 600 mg (two 300 mg tablets) twice daily taken with ritonavir 100 mg twice daily and with food. The type of food does not affect exposure to darunavir" (FDA, 2006a). Study participants taking the darunavir/ritonavir combination reported diarrhea, nausea, and headaches as side effects, and "[a]bout seven percent of patients on this combination therapy experienced skin rashes ranging from mild to serious" (FDA, 2006a). The risks and benefits of darunavir for adults who are antiretroviral-naïve, or for children, have not yet been established, but studies by the manufacturer will continue as a condition of the accelerated approval process for this medication.

FDA approved Sustiva in 1998, Viread in 2001 and Emtriva in 2003. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48 week clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla. In this trial, 80 percent of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells – cells that fight against infection.

The labeling of Atripla includes a boxed warning that the drug's use can cause lactic acidosis (buildup of lactic acid in the blood). In patients with chronic Hepatitis B infection, the discontinuation of the treatment with Atripla (which is not approved for this use) can result in severe flare-ups of Hepatitis B infection. Other potential serious adverse events reported for the use of Atripla's ingredients include serious liver toxicity, renal impairment and severe depression. The most common adverse events experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting and rash. (FDA, 2006b)

Given its association with frequent (although transient) neuropsychiatric complications, studies involving efavirenz (EFV) are continuing:

  o Ward and Curtin (2006) evaluated 40 recipients of HIV primary care who had achieved an undetectable or nearly undetectable viral load, but were experiencing neuropsychiatric side effects (e.g., depression, anxiety, or fatigue with or without sleep disturbances) or elevated lipid profiles and were therefore switched from an EFV-containing antiretroviral regimen to a nevirapine (Viramune®)-containing regimen. "In this study, the improvement or resolution of CNS [central nervous system] and psychiatric adverse effects, coupled with the maintenance of viral suppression, showed that switching to nevirapine-containing therapy may be an attractive choice for patients unable to tolerate long-term CNS and psychiatric or other side effects associated with efavirenz. ... Patients uniformly reported improvement of the neuropsychiatric symptoms, whether mild or severe, that prompted their regimen change" (p. 546).

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