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Daclatasvir plus sofosbuvir safe and effective in HCV/HIV coinfection

Patients treated with daclatasvir and sofosbuvir for hepatitis C who are coinfected with HIV have shown a significant virologic response, regardless of whether they had already been treated for their hepatitis C infection, according to data presented at the International AIDS Society Conference on HIV Pathogenesis, Treatment & Prevention.

The open-label ALLY-2 study – published simultaneously in the July 21 online edition of the New England Journal of Medicine – in 151 previously untreated patients with hepatitis C and HIV, and 52 previously treated patients, showed 12 weeks of treatment with NS5A inhibitor daclatasvir and sofosbuvir achieved a sustained virologic response in 96.4% of untreated patients and 97.7% of previously treated patients with HCV genotype 1, with no adverse effects on HIV-1 suppression.

Among previously untreated patients treated for 8 weeks, the response rate was 75.6%, and there were no study-drug discontinuations because of adverse events (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1503153]).

“The lower efficacy observed after 8 weeks of treatment suggests that 12 weeks of therapy may be preferred for most patients with HIV-HCV coinfection,” wrote Dr. David L. Wyles of the University of California, San Diego, and his coauthors.

Bristol-Myers Squibb supported the study. Dr. Wyles reported serving as a scientific consultant to Bristol-Myers Squibb and Gilead Sciences. Some coauthors declared grants, personal fees, and speakers fees from pharmaceutical companies, including Bristol-Myers Squibb, and several authors are employees of Bristol-Myers Squibb.

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Patients treated with daclatasvir and sofosbuvir for hepatitis C who are coinfected with HIV have shown a significant virologic response, regardless of whether they had already been treated for their hepatitis C infection, according to data presented at the International AIDS Society Conference on HIV Pathogenesis, Treatment & Prevention.

The open-label ALLY-2 study – published simultaneously in the July 21 online edition of the New England Journal of Medicine – in 151 previously untreated patients with hepatitis C and HIV, and 52 previously treated patients, showed 12 weeks of treatment with NS5A inhibitor daclatasvir and sofosbuvir achieved a sustained virologic response in 96.4% of untreated patients and 97.7% of previously treated patients with HCV genotype 1, with no adverse effects on HIV-1 suppression.

Among previously untreated patients treated for 8 weeks, the response rate was 75.6%, and there were no study-drug discontinuations because of adverse events (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1503153]).

“The lower efficacy observed after 8 weeks of treatment suggests that 12 weeks of therapy may be preferred for most patients with HIV-HCV coinfection,” wrote Dr. David L. Wyles of the University of California, San Diego, and his coauthors.

Bristol-Myers Squibb supported the study. Dr. Wyles reported serving as a scientific consultant to Bristol-Myers Squibb and Gilead Sciences. Some coauthors declared grants, personal fees, and speakers fees from pharmaceutical companies, including Bristol-Myers Squibb, and several authors are employees of Bristol-Myers Squibb.

Patients treated with daclatasvir and sofosbuvir for hepatitis C who are coinfected with HIV have shown a significant virologic response, regardless of whether they had already been treated for their hepatitis C infection, according to data presented at the International AIDS Society Conference on HIV Pathogenesis, Treatment & Prevention.

The open-label ALLY-2 study – published simultaneously in the July 21 online edition of the New England Journal of Medicine – in 151 previously untreated patients with hepatitis C and HIV, and 52 previously treated patients, showed 12 weeks of treatment with NS5A inhibitor daclatasvir and sofosbuvir achieved a sustained virologic response in 96.4% of untreated patients and 97.7% of previously treated patients with HCV genotype 1, with no adverse effects on HIV-1 suppression.

Among previously untreated patients treated for 8 weeks, the response rate was 75.6%, and there were no study-drug discontinuations because of adverse events (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1503153]).

“The lower efficacy observed after 8 weeks of treatment suggests that 12 weeks of therapy may be preferred for most patients with HIV-HCV coinfection,” wrote Dr. David L. Wyles of the University of California, San Diego, and his coauthors.

Bristol-Myers Squibb supported the study. Dr. Wyles reported serving as a scientific consultant to Bristol-Myers Squibb and Gilead Sciences. Some coauthors declared grants, personal fees, and speakers fees from pharmaceutical companies, including Bristol-Myers Squibb, and several authors are employees of Bristol-Myers Squibb.

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Daclatasvir plus sofosbuvir safe and effective in HCV/HIV coinfection
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Daclatasvir plus sofosbuvir safe and effective in HCV/HIV coinfection
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hepatitis C, HCV, HIV, coinfection, daclatasvir, sofosbuvir
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hepatitis C, HCV, HIV, coinfection, daclatasvir, sofosbuvir
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Key clinical point: Daclatasvir and sofosbuvir therapy achieves sustained virologic response in patients coinfected with hepatitis C and HIV, without compromising HIV suppression.

Major finding: Treatment with NS5A inhibitor daclatasvir and sofosbuvir achieved a sustained virologic response in 96.4% of untreated patients and 97.7% of previously treated patients with HCV genotype 1.

Data source: A prospective, open-label study in 203 untreated and treated patients with hepatitis C and HIV.

Disclosures: Bristol-Myers Squibb supported the study. Dr. Wyles reported serving as a scientific consultant to Bristol-Myers Squibb and Gilead Sciences. Some coauthors declared grants, personal fees, and speakers fees from pharmaceutical companies, including Bristol-Myers Squibb, and several authors are employees of Bristol-Myers Squibb.