Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

Inclusion Criteria

• •1. Each subject must be willing and able to provide written informed consent for the trial.
• •2. Each subject must be ≥ 18 years of age.
• •3. Each subject must be male or non-pregnant, non-breastfeeding female
• •4. Each subject must have diagnosis of HIV infection.
• •5. Each subject must have concomitant coinfection by HCV as shown by detectable plasma HCV RNA.
• •6. Each subject must have stable treatment with EFV plus two nucleoside analogs for ≥24 weeks.
• •7. Each subject must have at least 2 documented plasma HIV RNA \<50 copies/ml during the last 24 weeks, as observed in, at least, two clinical visits.
• •8. Each subject must have HS involving more than 10% of hepatocytes, as determined by a CAP measurement ≥238 dB/m.
• •9. Each sexually active female subject of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 3 months after stopping the medication.Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg,hysterectomy or tubal ligation).Postmenopausal women are not required to use contraception.Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
• •10. Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy.
• •11. Average daily alcohol intake lower than 50 g for men and 40 g for women.