Hep C Discussion Forum

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.

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