A study associated with central nervous system damage with the use of Kaletra monotherapy in patients with undetectable viral load
A small study whose results were published in the January 14 edition of the journal The AIDS Journal found elevations of certain markers of immune activation in the spinal fluid of people with HIV who were taking lopinavirritonavir monotherapy (Kaletra). These elevations, seen even in people with undetectable viral load, may be signs of possible damage to the central nervous system, which could result in neuro-cognitive impairment.
While the use of effective antiretroviral regimens has allowed life expectancy to increase dramatically and reduced the incidence of dementia in people with HIV, the central nervous system may suffer constant damage as a result of immune activation, viral escape or even toxicity of medicinal products.
As a result, now that new treatment options are available, and that many patients who have lived a long time with HIV and are aging, it is crucial to consider the potential side effects on the central nervous system when choosing treatment guidelines.
Simplification of antiretroviral therapy (HAART) is a strategy that is researched and sometimes requires practice for many reasons, such as increasing treatment comfort (???), reducing the number of pills, reducing and toxicity and reduce costs. Among the simplification strategies, the most common is the switch to monotherapy with a protease inhibitor driven by ritonavir (Norvir ®) after reaching the undetectable level with a standard antiretroviral regimen (HAART).
Kaletra ® is one of protease inhibitors, along with Prezista ® (darunavir) boosted by ritonavir (Norvir ®) has been most widely used as monotherapy. His power and the high genetic barrier to resistance development make it an attractive option for use as monotherapy. However, according to the new findings of this review, the use of unconventional treatment guidelines - as monotherapias - may be sometimes less effective than a standard three drugs in reduced immune activation and inflammation of the nervous system central.
The MAIS-acronym for monotherapy in Switzerland and Thailand - was a controlled, open study with the drug randomly distributed to participants from different undetectable viral load for more than six months and no failure in two groups: one patient continued therapy (continuation of the therapy arm) and the other patient was given lopinavirr (monotherapy arm) alone. The expected outcome for the study would be to maintain such groups for 48 weeks, and thereafter the two groups would then use monotherapy for more than 48 weeks. However, the study could not be completed since there was an intercurrence that generated a disturbance in the criteria attached to the test protocol: virological failure of six of the 30 first (20) monotherapy patients, patients with a lower CD4 count to 200 cells mm3 (see news of the day 26 / 02 / 2009).
On this occasion, the researchers evaluated spinal fluid samples from 34 participants of continued therapy arm; 31 of patients in the monotherapy arm and 29 seronegative controls with Alzheimer's disease in order to respect the levels of inflammation and immune activation markers as S100B (whose elevation indicates an astrocyte proliferation, glial cells that protect and support neurons) , neopterin (a marker of inflammation) and activation of macrophages and neuronal damage.
The analysis found that S100B levels were significantly higher in patients in the group than monotherapy in the continuation of participants in the therapy arm or in people with Alzheimer's disease, regardless of whether or not the viral load was undetectable in the control group. plasma or cerebrospinal fluid. Levels of Neopterin monotherapy, however, were significantly higher than in the other two groups only when included in the analysis of patients with HIV viral load detectable in plasma and cerebrospinal fluid.
In 16 HIV patients who formed a parallel control group - HIV levels in patients taking triple therapy and another level when they were given lopinavirritonavir monotherapy, S100B and neopterin, levels were significantly higher in samples collected during treatment with monotherapy.
Although the conclusions of this small study should be confirmed with larger clinical trials, the results are particularly disappointing regarding the use of monotherapy with ritonavir-boosted protease inhibitors - at least with lopinavirritonavir - because, in addition to the documented virological failures with these treatment strategies in different trials, there are now signs of constant central nervous system damage when using this non-standard antiretroviral guidance.
Considering that lopinavirritonavir is considered to be one of the antiretroviral drugs with better penetration into the cerebrospinal fluid, the conclusions of this study will call into question the efficacy of Kaletra ® to prevent and prevent central nervous system deterioration when used as monotherapy.
Note the Seropositive Editor Web Site: The population is aging with HIV and, so far, with "a certain quality of life." I myself am coming there to 51 years and if I used beards, already would have put my sauce. In my case the primary HIV infection was meningitis and notice, years later I had another meningitis ... I'm not given up hope of games and I am very objective when the thing comes to me. In addition to these two events, I suffer with a peripheral neuropathy, which makes me take well pesadinhas drugs such as gabapentin and Methadone, only to "mitigate" the pain.
I admit that, in most cases this works; today, however, do not feel my left hand, which is dormant. This is called paresthesia and is an unpleasant symptom, but much more friendly that my crisis soreness, which usually end up in the emergency room of St. Camillus, because it hurts the bessa nor injectable morphine has done more than relieve a couple of hours. So when the crisis is hyperesthesia I hope dent in my bed it to pass.
It is clear to me that my HIV infection operates extensively in my central nervous system and only God can avoid this.
Anyway, I'll live the way I told people live, when I volunteered in the CRTA. One day at a time ... But there are some who wtf
Another important thing is that there seems to be research to reduce costs of treatments and that these trials, although I believe they follow ethical standards that are not objectionable by the scientific community, I, who are not part of the community, nor (please do not distort my thinking by attributing to capitalization as a demonstration of respect) I cast doubt upon the correction and even the morality of changing the treatment of a person, which was having good results, for a method (the monotherapy) that in the 1980 decade and part of 1990, decimated millions of lives! Or will it be that, because it's a half dozen dripping cats, that's okay and come on. And to finish, I take 22 tablets a day, I do not feel bothered by them and, if they reduce my treatment in this way I will feel abandoned even by my infected ... And, once again: PQP