Abbvie all-oral 3D combo works well for people with HIV/HCV coinfection
Cinnamon Girl said
Sep 10, 2014
An all-oral regimen of 3 direct-acting antivirals plus ribavirin taken for 12 weeks led to sustained virological response in 94% of HIV positive people with mostly genotype 1a hepatitis C coinfection in the TURQUOISE-I study, according to data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2014) this week in Washington, DC.
People with HIV/HCV coinfection experience more rapid liver disease progression than people with HCV alone and do not respond as well to interferon-based therapy, but several studies suggest that having HIV is no longer a predictor of poorer response when using interferon-free regimens.
Joseph Eron from the University of North Carolina at Chapel Hill presented findings from the Phase 3 TURQUOISE-I trial, which evaluated the safety and efficacy of AbbVie's 3D regimen for HIV/HCV coinfected patients.
This regimen contains the HCV protease inhibitor ABT-450 (150 mg), a boosting dose of ritonavir (100 mg), and the NS5A inhibitor ombitasvir (formerly ABT-267; 25 mg), all in a once-daily coformulation, taken with the twice-daily non-nucleoside HCV polymerase inhibitor dasabuvir (formerly ABT-333; 250 mg). Because coinfected people are considered harder to treat, all participants in this open-label trial also received weight-based ribavirin and they were randomly assigned to 12 or 24 weeks of therapy.
Results -
SVR4 rates at 4-weeks post-treatment were 94% in the 12-week arm and 97% in the 24-week arm.
With no further relapses, the SVR12 rate in the 12-week arm remained at 94%.
1 person experienced HCV relapse at 2 weeks post-treatment and 1 experienced viral breakthrough at week 16 while on treatment.
Both of these patients were prior null responders with cirrhosis who had HCV subtype 1a and the least favorable IL28B TT gene variant.
The 3D regimen plus ribavirin was generally safe and well-tolerated.
The most common side effects were fatigue, insomnia, nausea, and headache, mostly mild or moderate.
No participants experienced serious adverse events or discontinued treatment for this reason.
Looking at laboratory abnormalities, 35% of participants in the 12-week experienced bilirubin elevation, a known side effect of atazanavir.
4 people in the 12-week arm and 3 in the 24-week arm developed low hemoglobin, but no one progressed to severe anemia.
6 patients reduced their ribavirin dose due to anemia, but all went on to achieve SVR.
Participants maintained good HIV control, with none having confirmed HIV RNA >200 copies/mL and no notable changes in CD4 count.
An all-oral regimen of 3 direct-acting antivirals plus ribavirin taken for 12 weeks led to sustained virological response in 94% of HIV positive people with mostly genotype 1a hepatitis C coinfection in the TURQUOISE-I study, according to data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2014) this week in Washington, DC.
People with HIV/HCV coinfection experience more rapid liver disease progression than people with HCV alone and do not respond as well to interferon-based therapy, but several studies suggest that having HIV is no longer a predictor of poorer response when using interferon-free regimens.
Joseph Eron from the University of North Carolina at Chapel Hill presented findings from the Phase 3 TURQUOISE-I trial, which evaluated the safety and efficacy of AbbVie's 3D regimen for HIV/HCV coinfected patients.
This regimen contains the HCV protease inhibitor ABT-450 (150 mg), a boosting dose of ritonavir (100 mg), and the NS5A inhibitor ombitasvir (formerly ABT-267; 25 mg), all in a once-daily coformulation, taken with the twice-daily non-nucleoside HCV polymerase inhibitor dasabuvir (formerly ABT-333; 250 mg). Because coinfected people are considered harder to treat, all participants in this open-label trial also received weight-based ribavirin and they were randomly assigned to 12 or 24 weeks of therapy.
Results -
Link to full article...
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4825-icaac-2014-abbvie-3d-regimen-works-well-for-people-with-hivhcv-coinfection