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HIV and MS: Could a Link Lead to New MS Treatment: VIDEO

Two clinical trials are now underway that offer the first tests of an intriguing but still not widely accepted theory of multiple sclerosis -- that its trigger lies within a part of the human genome that medical research has largely ignored.

Some researchers in Great Britain and Europe now believe that MS results from activation of "human endogenous retroviruses," or HERVs -- remnants of retroviruses that infected humans eons ago and became incorporated into the germline, such as that it is now part of the human genome.
This theory has prompted a group in the U.K. to begin a trial of the HIV drug raltegravir (Isentress) in about 25 MS patients, to see if the drug affects brain lesions seen in MRI scans. The trial is expected to conclude this August, with results potentially reported before the year is out.
Separately, a Swedish company called GeNeuro Innovation, founded by Swiss researcher Herve Perron, PhD, has developed a monoclonal antibody called GNbAC1 targeting a specific HERV element; safety results from a phase II trial are slated for presentation next month at the American Academy of Neurology's annual meeting.

The HIV Connection
Perhaps the most significant piece of evidence for the HERV theory of MS is even more indirect: People with HIV appear to be at vastly reduced risk for MS.
What does HIV status have to do with HERVs or MS? Because nowadays, essentially everyone with HIV in developed countries where broad-based epidemiological research can be conducted is treated with antiretroviral drugs.
Gold is an HIV specialist -- the Albion Street Centre, which he directs, is Australia's largest HIV outpatient clinic. His "aha" moment came when an HIV-positive patient who also had MS came under his care. This patient was first diagnosed with HIV infection in 1985 but managed to avoid developing AIDS before the advent of highly active antiretroviral therapy (HAART) in 1996.
In a 2011 letter published in the European Journal of Neurology, Gold and colleagues described what happened after HAART was begun in 1996:
"Within months of commencing HAART, all MS symptoms gradually improved. Within 2 years, his urinary incontinence was controlled to the extent that he stopped wearing pads and fecal incontinence resolved. He has had no MS relapses."
The disease was not completely eliminated, the researchers indicated, because gadolinium-enhanced MRI scans made in 2002 continued to show lesions consistent with MS, even though clinical symptoms had largely disappeared.
Large-scale epidemiological studies have supported the notion that anti-HIV therapy may suppress MS pathology. A Danish national registry study published in letter form last year inEpidemiology, comparing 5,018 HIV-positive patients with some 50,000 age- and sex-matched individuals from the general population, found that the rate of MS incidence was markedly lower in the HIV patients (3.1 versus 10.4 per 100,000). However, it was not statistically significant because only one HIV patient developed MS during the study period.
Gold and colleagues conducted a similar (but as yet unpublished) study using the much larger U.K. general practice database, which covers some 55 million Britons. At the European MS meeting where he spoke last fall, he reported on results from some 21,000 HIV-positive individuals and 6.7 million controls, followed for a mean of 7 years.
In addition to matching controls to HIV patients by age and sex, they were also matched by region within the country and by the week in which they first came into contact with the national health system.
The relative risk for MS in the HIV patients versus controls was 0.38 (95% CI 0.15-0.79,P=0.011), he reported. The relative risk was even lower, 0.22, when only MS diagnoses occurring more than 1 year after HIV diagnosis were counted (at which point HAART is presumably well established in British HIV patients).
The Clinical Trials
There is no animal model for HERVs in MS, and the ability to study HERVs even in cell culture is limited, Gold said. He argued that "their exact role will only be obtained following appropriate clinical trials. If we wait for the laboratory to give us the answer, we will all have been retired."
Raltegravir was chosen for the U.K. trial for several reasons. One is that it is an HIV integrase inhibitor. "The integrases across HERVs and HIV are quite conserved," Giovannoni said, so that it is likely to be more effective in suppressing HERV elements than other types of antiretroviral drugs. He said it was also unique among antiretrovirals in also showing some potency against members of the herpesvirus family (though only in vitro -- this effect hasn't been studied clinically).
And, its manufacturer was willing to support the small, short-term trial. Gold pointed out that no company that markets MS medications is active in HIV drug development, or vice versa. He and Giovannoni were able to persuade raltegravir's maker, Merck's European subsidiary, to fund the 25-patient study which includes just 3 months of drug treatment after a 3-month baseline observation period. Gold said a longer and larger study would have been preferable but it could not be arranged.
The GNbAC1 monoclonal antibody's sponsor GeNeuro appears to have more resources, with France's Institut Merieux as a major investor. It has already completed a phase I safety study with the agent in healthy volunteers; the results to be presented at the AAN meeting next month are from 10 MS patients.
According to the abstract, no safety problems were seen, and a larger efficacy study is warranted. However, GeNeuro has not said whether or when such a trial would be undertaken.

Story Source: The above story is based on materials provided by MEDPAGETODAY
Note: Materials may be edited for content and length


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