Sequelae of acute hepatitis C virus infection among HIV positive MSM, HIV negative MSM and HIV positive heterosexuals: the MOSAIC cohort.

In the Netherlands and other industrialized countries hepatitis C virus (HCV)
is emerging as a sexually transmitted infection (STI) among HIV infected men
who have sex with men (MSM). Case reports also describe sexual transmission of
HCV in HIV negative MSM and HIV positive heterosexuals. HIV/HCV coinfection has
been associated with accelerated progression to HCV, possibly HIV-related
disease and less success in treatment of HCV. However, limited information is
available on the sequelae of acute HCV infection in HIV infected individuals.

To study a cohort of HIV infected and HIV uninfected MSM and HIV infected
heterosexuals who (subsequently) acquired HCV infection with a known date of
HCV seroconversion:
1. To identify the frequency, clinical consequences and determinants (viral and
host factors) of acquiring acute (primary, re- or super) HCV infection in HIV
positive MSM, HIV negative MSM and HIV positive heterosexuals
2. To assess the outcome of HCV treatment following acute infection in HIV
positive MSM, HIV negative MSM and HIV positive heterosexuals
3. To study the impact of acute HCV infection on the morbidity and mortality in
HIV positive and HIV negative MSM and HIV positive heterosexuals
4. To study the role of HIV positive MSM who acquire acute HCV in the HIV
epidemic among HIV negative MSM
5. To identify the driving factors of the HCV outbreak among MSM, in particular
the role of HIV

The study is open prospective observational cohort study. HIV positive MSM, HIV
negative MSM and HIV positive heterosexuals with a (subsequently) acquired
acute HCV infection will be asked by their HIV-specialist or hepatologist to
join the study. Participant can be included at the time of acute HCV infection
(prospective participants) or if they were diagnosed with acute HCV infection
in the past (time of seroconversion must be known). To be able to study the
first objective, per prospectively included HIV positive MSM with acute HCV,
two controls per participant will be asked to join the study. Data collection
mostly takes place during regular visits at either the HIV or hepatology
outpatient clinic. The data
collected will mostly exist of data the specialist already collects for regular
treatment or control. Extra data collection will exist of blood samples for
virological, immunological and genetical study and questionnaires for study of
(sexual) risk behaviour and quality of life. The follow-up of participants of
this study will be for an -at the moment- indefinite period of time. The
follow-up of control patients ends after two years.

The majority of the data collection for this study will take place during
regular visits at either the HIV- or hepatology outpatient clinic, and the
majority of data that will be collected for this study will comprise of data
that are also collected for the regular care.

Participants with acute HCV: extra visits will take place:
- during the period in between time of inclusion and treatment, when a
particpiant will not directly start treatment or will not start treatment at
all. Participant wll be asked to give permission for extra blood sampling every
four weeks during the first three months after inclusion.

Participants with acute HCV: extra data collected during regular visits:
- at 3 timepoints during the first period of 6-9 months after inclusion filling
in a questionnaire concerning risk behaviour (prospective participants)
- at 3 timepoints during the first period of 6-9 months after inclusion filling
in a questionnaire concerning quality of life (prospective participants)
- after the treatment period/first 6 months we will ask the participants in
follow-up to fill in these questionnaires once a year
- during the regular visits in the treatment period their will be very regular
blood samples taken to check on the effect oftreatment. We will ask
participants their permission to take one to three extra tubes for the study
during the regular venapunctions (10-35 ml blood)
- one fibroscan of the liver (in most patients all ready performed as standard
of care)

Control patients: extra visits:
- no extra visits are necessary

Control patients: extra data collected during regular visits:
- 4 times during 2 years filling in a questionnaire concerning risk behaviour
- 4 times during 2 years filling in a questionnaire concerning quality of life
- during the regular visits regular blood samples will be taken. We will ask
control participants their permission to take one to three extra tubes for the
study during the regular venapunctions (10-35 ml blood) for 5 times in total
- one fibroscan of the liver

The participant will be asked to fill in these questionnaires during their
visit at the clinic (max 20 min). When a participant will not be able to do
this during the visit, he will be asked to fill in the questionnaires at home
and to send these back to the researcher.