Treatment of HIV with efavirenz may have side effects
TRANSLATOR'S NOTE: There is a constant allusion to the acronym ACTG which represents, in the English language AIDS Clinical Trials Group, which in free translation would be: AIDS Clinical Trials Group which is a disguised form, a euphemism to say that humans are being Used as guinea pigs, and although I recognize the need for these ACTGs, the case below offends the little morale that I still have and translates it not only to give opportunity to people or relatives of people lost because of these lessons that now come to their Eyes, and, on the other hand, an unsuspecting soul, thirsting for salvation or benevolence, that serves as a warning about what may be behind an "invitation like this" (...)
Suicidal ideation and its successful or non-successful completion prove that HIV treatment with efavirenz may have side effects and lead to suicide
Suicidal thoughts, suicide attempts and death by suicide were more than twice as common among people with HIV who started treatment with efavirenz (Sustiva or Stocrin, also on the Atripla combination pill), but the overall risk was quite low, According to a combined analysis of four ACTG trials presented Friday at the IDWeek 2013 meeting in San Francisco that demonstrated that Treatment of HIV with efavirenz may have side effects and that the harm caused by it may negate the "benefits that it offers, and I will note here what will be seen below. When a drug loses its "commercial value," since it will become generic, there is a wide variety of reasons why it should not be used, and so why not all of this was seen before launch, I study speaking below and consummate suicides "
Efavirenz has a well-known association with side effects in the central nervous system which may include abnormal dreams, depression and anxiety. Several studies have reported cases of suicide among people taking efavirenz, alerting the scientific community that treatment of HIV with efavirenz may have side effects, but "its frequency has not been determined." The Sustiva package states that suicide, psychotic delusions and behavior were reported among people who took the drug, but "A causal relationship to the use of Sustiva can not be determined from these reports".
Katie Mollan of the University of North Carolina And his colleagues developed a study to estimate the incidence of "suicidal thoughts" and compare the time of possibility of suicidal thoughts among the naive adults of HIV treatment who were randomly assigned to receive "Efavirenz-free " Or non-efavirenz regimens in AIDS Clinical Trials Group (ACTG) studies conducted between 2001 and 2010. "Suicide" (NT: Disgusting neologism in two languages) was defined as a compound of suicidal thoughts (ideation), attempts Or completed suicides (...).
This retrospective analysis included 3241 participants from randomized studies for regimens containing efavirenz and 2091 attributed to free combinations of efavirenz. Basal characteristics were similar in both groups. Nearly three quarters were men and the average age was about 36 years. About 75% were from the US; Within this group, 39% were white and 36% were black. About 15% had a previous diagnosis of AIDS, 8% had a history of injecting drug use, a third had a history of psychiatric diagnosis or psychiatric prescription and 10% received antidepressants.
The four trials in the analysis (A5095, A5142, A5175 and A5202) - three of which were tested in the open-label trial with efavirenz in combination with nucleoside reverse transcriptase (INTI) inhibitors including AZT (zidovudine, Retrovir), 3TC (lamivudine, Epivir), abacavir (Ziagen), emtricitabine (Emtriva) and / or tenofovir (Viread, or with emtricitabine in Truvada); One trial combined efavirenz with lopinavir / ritonavir (Kaletra). Comparison regimens without efavirenz included three NRTIs or lopinavir / ritonavir or atazanavir enhancing (Reyataz) plus two NRTIs.
Participants were followed for a median of 150 weeks, or about three years. For two trials, the primary analysis included results until data safety and monitoring panels recommended stopping efavirenz free arms due to inferior efficacy; Efavirenz continued treatment and follow-up up to a maximum of 184 weeks.
A total of 47 events
Suicidal Occurred in the arms containing efavirenz compared to 15 in the efavirenz free arms during the comparison period for the 8,08 and 3,66 event rates per 1000 person-years, respectively. The risk ratio (RH) for possibility of suicidal thoughts was 2,28 - or more than twice the risk - in an intention-to-treat analysis and the difference was statistically significant. A treated analysis showed a similar pattern with a risk ratio of 2,16.
In both groups, the incidence of suicide increased more sharply in the first six months after initiation of antiretroviral therapy. Among people taking efavirenz, the incidence increased steadily, with another leap over a period of about two and a half years. In the group without efavirenz, the
Suicide Stabilized around 30 weeks after the start of the study, with a New increase Around two years.
Leaving aside suicidal thoughts or ideation, There were 17 attempts or suicides Completed (ending in death) Among those randomized to efavirenz-containing regimens, compared to five among those who took free combinations of efavirenz.This gave 2,58 hazard ratios for the intent-to-treat analysis and 2,30 for the treated analysis.
After the free arms of efavirenz were discontinued in two trials, The total number of completed attempts or suicides reached 27 between efavirenz receptors and seven among those previously in the arms without efavirenz, for a risk ratio of 2,60.
Factors significantly associated with suicidal thoughts in a multivariate analysis included efavirenz, younger age (HR 2,80 for age <30) and history of injecting drug use (HR 2,18). But the major risk factor was a previous psychiatric diagnosis or use of psychiatric medications, with a risk rate of 3,90 - a nearly four-fold increased risk.
The researchers concluded that initial treatment with a regimen containing efavirenz was associated with a two-fold increase in suicide risk and a 2,5 risk greater than attempted or completed suicide.
"Suicidability (...) was unusual, but reported in each study and subgroup evaluated," they added.
They also noted that death by suicide, injury, or unknown causes - which are sometimes combined when reporting suicide study results, and recommended that "Careful attention should be paid to the cause of death in all clinical trials, always remembering that during these trials it was noted that HIV treatment with efavirenz may have side effects such as depression and ucide".
As a reminder, Joel Gallant of the Southwest Care Center noted that more reports of neuropsychiatric side effects and suicide related to efavirenz are coming out now as the drug is about to disappear. "It is only when it becomes generic that people come to find a thousand and one reasons why we should not use it," he said.
Translated by Claudio Souza, the original Does efavirenz raise the risk of suicide in people with HIV? In XXVII-V-MMXXVII
And I'll chorus with him, Joel Gallant.
While it yields millions, and it is always so, with any remedy, to treat any pathology the metric is the same:
Let's leave them, the victims, while they bring us profits ... When we are very close to seeing them become generic ... well ... there, we warn