Treataware

This may be the proposed or expected start date for trials which have not yet started.

The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.

• At least 18 years old
• HIV-positive
• Positive test for active hepatitis B virus (HBV) infection

• ClinicalTrials.gov
• NCHECR

• HIV/HBV coinfection and tenofovir resistance
• HIV/HBV coinfection and liver disease
• HIV/HBV or HIV/HCV coinfection

The Tenofovir in HIV and hepatitis B (HBV) Coinfection study (TICO) was a randomized clinical trial performed at the HIV-NAT (Netherlands-Australia-Thailand) research institute in Bangkok, Thailand. The study compared 3 treatments for Hepatitis B in people initiating antiretroviral therapy for HIV; Arm 1: lamivudine (LAM) monotherapy versus Arm 2: tenofovir (TDF) monotherapy versus Arm 3: HBV combination therapy with lamivudine and tenofovir (LAM/TDF) all in combination with other antiretroviral agents.. Thirty-six HIV/HBV-coinfected individuals were enrolled and treated for 48 weeks. After 48 weeks there was no significant difference between the treatments in overall reduction of HBV DNA. However there was a significant difference between the treatments in terms of suppression of HBV DNA to less than 1000 copies per ml. This occurred in 46% of subjects receiving LAM compared to 92% of subjects receiving TDF and 91% of subjects receiving LAM/TDF. Mutation of the virus associated with LAM resistance was detected in two individuals, both receiving LAM only. No subjects receiving TDF had viral mutation associated with LAM resistance. Loss of HBeAg loss was observed in 33% of HBeAg-positive subjects, and 8% of subjects overall experienced HBsAg loss. Hepatic flare (defined as an increase in liver enzymes 5 x above baseline levels) was observed in 25% of subjects and was associated with higher HBV DNA and ALT levels at baseline. One patient in the study died at week 8 from hepatic flare despite cessation of trial medication. This patient had advanced liver disease (cirrhosis) and a very low CD4 count at baseline. In summary LAM monotherapy resulted in a greater proportion of subjects with HBV DNA levels over 1000 copies/ml after 48 weeks of treatment and in the early development of resistance. The findings from this trial support current treatment guidelines recommending a TDF-based regimen as treatment of choice for HIV/HBV coinfection, but did not demonstrate any advantage of HBV combination therapy, at least in this short-term setting. In the initial trial design it was also planned to recruit a parallel group of 15 HBV monoinfected subjects to perform a 12 week comparative viral kinetic study. This component of the study was to be recruited from Australia, however due to recruitment difficulties, only 3 HBV monoinfected subjects were enrolled in this part of the study and thus no further analysis on these subjects is planned.

Tenofovir is a registered PBS drug in Australia