Two regimens achieve high response in HCV/HIV coinfection

Patients coinfected with HIV and hepatitis C genotype 1 show high response rates to a three-drug regimen of ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir, plus ribavirin, according to an open-label, uncontrolled pilot study published in JAMA.

Among the 63 patients – who were either HCV treatment-naive or had previously experienced treatment failure with peginteferon plus ribavirin – treated with the all-oral ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir (known as 3D) plus ribavirin regimen, 94% of those treated for 12 weeks and 91% of those treated for 24 weeks achieved a sustained virologic response 12 weeks (SVR12) after treatment.

There were no confirmed HIV breakthroughs or serious adverse events – even though the study group included some patients with compensated cirrhosis – although around half of patients experienced treatment-related fatigue, 19% experienced insomnia, 18% experienced nausea, and 16% experienced headache (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1328]).

“The efficacy and safety of the 3D-plus-ribavirin regimen for patients co-infected with HCV/HIV-1 need to be further investigated in larger studies; however, response rates reported here are similar to those in studies of HCV-monoinfected patients, which suggest that difficult-to-cure patients, such as prior [pegylated interferon] null responders with cirrhosis and HCV genotype 1a, may benefit from longer treatment duration,” wrote Dr. Mark S. Sulkowski, director of the viral hepatitis center and professor of medicine at Johns Hopkins University, Baltimore, and his colleagues.

In another study, researchers found that a 12-week course of a fixed-dose combination of ledipasvir and sofosbuvir in treatment-naive patients with hepatitis C genotype 1 and HIV coinfection achieved sustained virologic response rates of 98% at 12 weeks after treatment.

The open-label, phase 2b study in 50 patients recorded one case of relapse at week 4, which may have been linked to resistance-associated mutation, but no discontinuations or serious adverse events attributable to the study drug (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1373]).

The study excluded individuals with cirrhosis, but many participants had poor prognostic factors, including African American race, male sex, IL28B non-CC genotype, and genotype 1a infection.

“These results show for the first time, to our knowledge, that an interferon- and ribavirin-free therapy is associated with high SVR rates in patients co-infected with HCV and HIV,” wrote Dr. Anu Osinusi of the University of Maryland, Baltimore, and her colleagues.

Dr. Sulkowski’s study was funded by AbbVie. Some of his coauthors declared a range of funding and consultancies from pharmaceutical companies including AbbVie and several coauthors are employees of AbbVie.

Dr. Osinusi’s study was funded by the National Institutes of Health, the German Research Foundation, and Gilead Sciences. Four coauthors reported speaking engagements, consultancies, fees, grants, stocks and other support from pharmaceutical companies including Gilead.

Patients coinfected with HIV and hepatitis C genotype 1 show high response rates to a three-drug regimen of ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir, plus ribavirin, according to an open-label, uncontrolled pilot study published in JAMA.

Among the 63 patients – who were either HCV treatment-naive or had previously experienced treatment failure with peginteferon plus ribavirin – treated with the all-oral ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir (known as 3D) plus ribavirin regimen, 94% of those treated for 12 weeks and 91% of those treated for 24 weeks achieved a sustained virologic response 12 weeks (SVR12) after treatment.

There were no confirmed HIV breakthroughs or serious adverse events – even though the study group included some patients with compensated cirrhosis – although around half of patients experienced treatment-related fatigue, 19% experienced insomnia, 18% experienced nausea, and 16% experienced headache (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1328]).

“The efficacy and safety of the 3D-plus-ribavirin regimen for patients co-infected with HCV/HIV-1 need to be further investigated in larger studies; however, response rates reported here are similar to those in studies of HCV-monoinfected patients, which suggest that difficult-to-cure patients, such as prior [pegylated interferon] null responders with cirrhosis and HCV genotype 1a, may benefit from longer treatment duration,” wrote Dr. Mark S. Sulkowski, director of the viral hepatitis center and professor of medicine at Johns Hopkins University, Baltimore, and his colleagues.

In another study, researchers found that a 12-week course of a fixed-dose combination of ledipasvir and sofosbuvir in treatment-naive patients with hepatitis C genotype 1 and HIV coinfection achieved sustained virologic response rates of 98% at 12 weeks after treatment.

The open-label, phase 2b study in 50 patients recorded one case of relapse at week 4, which may have been linked to resistance-associated mutation, but no discontinuations or serious adverse events attributable to the study drug (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1373]).

The study excluded individuals with cirrhosis, but many participants had poor prognostic factors, including African American race, male sex, IL28B non-CC genotype, and genotype 1a infection.

“These results show for the first time, to our knowledge, that an interferon- and ribavirin-free therapy is associated with high SVR rates in patients co-infected with HCV and HIV,” wrote Dr. Anu Osinusi of the University of Maryland, Baltimore, and her colleagues.

Dr. Sulkowski’s study was funded by AbbVie. Some of his coauthors declared a range of funding and consultancies from pharmaceutical companies including AbbVie and several coauthors are employees of AbbVie.

Dr. Osinusi’s study was funded by the National Institutes of Health, the German Research Foundation, and Gilead Sciences. Four coauthors reported speaking engagements, consultancies, fees, grants, stocks and other support from pharmaceutical companies including Gilead.

Patients coinfected with HIV and hepatitis C genotype 1 show high response rates to a three-drug regimen of ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir, plus ribavirin, according to an open-label, uncontrolled pilot study published in JAMA.

Among the 63 patients – who were either HCV treatment-naive or had previously experienced treatment failure with peginteferon plus ribavirin – treated with the all-oral ombitasvir, paritaprevir codosed with ritonavir, and dasabuvir (known as 3D) plus ribavirin regimen, 94% of those treated for 12 weeks and 91% of those treated for 24 weeks achieved a sustained virologic response 12 weeks (SVR12) after treatment.

There were no confirmed HIV breakthroughs or serious adverse events – even though the study group included some patients with compensated cirrhosis – although around half of patients experienced treatment-related fatigue, 19% experienced insomnia, 18% experienced nausea, and 16% experienced headache (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1328]).

“The efficacy and safety of the 3D-plus-ribavirin regimen for patients co-infected with HCV/HIV-1 need to be further investigated in larger studies; however, response rates reported here are similar to those in studies of HCV-monoinfected patients, which suggest that difficult-to-cure patients, such as prior [pegylated interferon] null responders with cirrhosis and HCV genotype 1a, may benefit from longer treatment duration,” wrote Dr. Mark S. Sulkowski, director of the viral hepatitis center and professor of medicine at Johns Hopkins University, Baltimore, and his colleagues.

In another study, researchers found that a 12-week course of a fixed-dose combination of ledipasvir and sofosbuvir in treatment-naive patients with hepatitis C genotype 1 and HIV coinfection achieved sustained virologic response rates of 98% at 12 weeks after treatment.

The open-label, phase 2b study in 50 patients recorded one case of relapse at week 4, which may have been linked to resistance-associated mutation, but no discontinuations or serious adverse events attributable to the study drug (JAMA 2015 Feb. 23 [doi:10.1001/jama.2015.1373]).

The study excluded individuals with cirrhosis, but many participants had poor prognostic factors, including African American race, male sex, IL28B non-CC genotype, and genotype 1a infection.

“These results show for the first time, to our knowledge, that an interferon- and ribavirin-free therapy is associated with high SVR rates in patients co-infected with HCV and HIV,” wrote Dr. Anu Osinusi of the University of Maryland, Baltimore, and her colleagues.

Dr. Sulkowski’s study was funded by AbbVie. Some of his coauthors declared a range of funding and consultancies from pharmaceutical companies including AbbVie and several coauthors are employees of AbbVie.

Dr. Osinusi’s study was funded by the National Institutes of Health, the German Research Foundation, and Gilead Sciences. Four coauthors reported speaking engagements, consultancies, fees, grants, stocks and other support from pharmaceutical companies including Gilead.