Ondamaris investigates: Why are HIV-positive excluded from hepatitis C studies?

The treatment of hepatitis C is facing major upheavals - very effective in significantly fewer side effects than existing therapies. But - HIV-positive are often still excluded.

Several new drugs are being tested in Phase III trials for hepatitis C. The results so far are very promising. You can hope that, ultimately, not only to existing therapies can be significantly enhanced - it can soon seem possible that treatment of hepatitis C could do without the (not just side effects) of interferon (see relevant investor'Befürchtungen ', (3 )).

HIV-positive have an increased risk of becoming infected with hepatitis C. And in HIV-positive people who are co-infected with hepatitis C, there is a risk that the hepatitis C infection progresses faster than in a singular HCV infection.

But - those are the people with HIV from trials of new drugs against hepatitis C currently most excluded in principle.

For example, a search in the new 'EU Clinical Trials Register' example of a Phase III study of the hepatitis C protease inhibitor telaprevir study (EudraCT Number: 2010-021628-84):

Principal exclusion criteria:
...
18. Subject has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection. "

While there are now examining studies, the HCV protease inhibitor in HIV-positive (first data were presented at CROI 2011, see (1)) - but only occasionally. And initial studies show that these drugs work well in HIV-positive - one less reason, people with HIV continue to be excluded from future studies. In addition, first data were presented to interact with HIV medications (2). Another reason for less.

This exclusion is done with reason - and certainly not with discriminatory intent.

Thus, treatment of both infections (hepatitis C and HIV) is more complicated than the treatment of a single infection. And the interpretation of study results could prove complicated. On interactions between HIV treatment and new hepatitis C substances (naturally) still not well known.

But - all this, in fact, people with HIV generally justifies excluded from studies with promising hepatitis C drug?

Justify this, they thereby - to withhold further options - they are particularly important - treatment?

Justify this exclusion on a principal of a whole group who are at increased risk of infection with hepatitis C have? And that also is at increased risk of faster disease progression?

Researchers and sponsors must ask themselves whether this exclusion principle is responsible yet.

Admission authorities and ethics committees must ask themselves whether this exclusion principle is still acceptable.

But - in the end will probably not change this, as long as HIV-positive who are also co-infected with hepatitis C, not even "get your ass up", some pressure to engage themselves and fight for their rights and health ...

Thanks to Armin sheep Berger (DAH) and Kees Rümke (Hiv Vereniging Nederland) for advice!

(1) see for example aidsmap 02/03/2011: telaprevir works well for people with HIV / HCV co-infection
(2) POZ 03/03/2011: Hepatitis C protease inhibitor telaprevir Interacts With HIV Drugs
(3) The Street 08/03/2011: Pharmasset Hep C Data Wows Investors
Hiv Vereniging Nederland 18/03/2011: HCV remmers op Komst

Source: Ondamaris.de