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CROI 2016: Primary Care Providers Can Successfully Treat People with Hepatitis C

Direct-acting antiviral therapy for hepatitis C delivered by non-specialists such as primary care physicians and nurse practitioners is safe and effective -- even for the most difficult-to-treat patients -- and could potentially help increase the number of people receiving treatment, according to findings from the ASCEND study presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) last month in Boston.


CROI 2016: Ravidasvir Plus Sofosbuvir Demonstrates High Cure Rate for HCV Genotype 4

Sofosbuvir plus the investigational HCV NS5A inhibitor ravidasvir, with or without ribavirin, cured 95% to 100% of people with hepatitis C virus (HCV) genotype 4, the most common type in Egypt, according to findings from the Pyramid 1 study presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016)last week in Boston.


AASLD 2015: Sofosbuvir Plus Ribavirin Shows Suboptimal Efficacy for Acute Hepatitis C

A combination of sofosbuvir (Sovaldi) and ribavirin cured more than 90% of HIV-positive people with acute hepatitis C virus (HCV) in a small study, but a similar trial of the same regimen saw a much higher relapse rate, according to a pair of presentations at the AASLD Liver Meeting this past November.


CROI 2016: Harvoni for 6 Weeks Cures HIV+ People with Acute HCV if Viral Load is Low

An interferon- and ribavirin-free regimen of sofosbuvir/ledipasvir (Harvoni) taken for just 6 weeks was enough to cure HIV-positive people with recent hepatitis C virus (HCV) infection if their HCV viral load was low, but those with high HCV levels may need longer treatment, according to study findings presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016)this week in Boston. Presenter Jürgen Rockstroh of the University of Bonn predicted that HCV viral load will become a key factor when making decisions about treating acute hepatitis C.


Studies done in the interferon era showed that treating people during the acute stage of HCV infection led to much higher response rates and required a shorter duration than interferon-based therapy started during chronic infection.

The advent of direct-acting antivirals (DAAs) in interferon-free regimens has made chronic hepatitis C treatment shorter, better tolerated, and more effective, and many experts expected the same would be true for acute HCV infection. But a combination of sofosbuvir plus ribavirin taken for 12 weeks produced a sustained response rate of only 59% in a small study of HIV-positive men with acute hepatitis C presented at the recent 2015 AASLD Liver Meeting.

There are currently no specific direct-acting antiviral regimens approved for the treatment of acute HCV infection. Current guidelines recommend using the same DAA options as for chronic infection, or even continuing to use interferon and ribavirin.

Rockstroh and colleagues conducted a study to evaluate the safety and efficacy of short-duration treatment using the HCV NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir for HIV-positive people with genotype 1 or 4 acute hepatitis C.

The analysis included 26 HIV-positive participants at 5 sites in Germany and the U.K. All were men, most were white, and the mean age was 41 years. They had acute HCV infection, defined as a positive HCV RNA test following a negative HCV antibody or RNA test within the past 6 months, or elevated ALT/AST during the past 6 months with no other known cause. About two-thirds had HCV genotype 1a and the rest genotype 4; the mean HCV viral load at baseline was 5.4 log IU/mL.

Participants could either be on antiretroviral therapy (ART) with suppressed HIV viral load or not on ART with no plans to start. Treated patients were using a variety of antiretrovirals that can be co-administered with sofosbuvir/ledipasvir. The most common regimens were efavirenz (Sustiva), raltegravir (Isentress), dolutegravir (Tivicay), or boosted atazanavir (Reyataz) plus tenofovir/emtricitabine (the drugs in Truvada).

All participants in this open-label study received sofosbuvir/ledipasvir in a fixed-dose coformulation for 6 weeks.

The usual recommended duration of sofosbuvir/ledipasvir for chronic hepatitis C treatment is 12 weeks, though easier-to-treat patients with no prior treatment experience, no cirrhosis and low viral load can be treated for 8 weeks.


  • After 6 weeks of therapy and 12 weeks of post-treatment follow-up, 20 of 26 participants (77%) achieved sustained virological response (SVR12), or continued undetectable HCV RNA.
  • 4 patients experienced virological failure -- 3 relapses and 1 reinfection with a different HCV genotype -- and 2 were lost to follow-up.
  • All 3 relapsers had high baseline HCV viral load above 7.0 logIU/mL; 2 had genotype 1a and 1 had genotype 4.
  • No new NS5A or NS5B resistance-associated viral variants were detected at the time of relapse.
  • Treatment was generally safe and well-tolerated with 1 unrelated serious adverse event and no treatment discontinuations for this reason.
  • The most common adverse events were fatigue (7%), nasopharyngitis (7%), and headache 6%), mostly mild or moderate.
  • Safety profiles were similar for patients receiving boosted or unboosted tenofovir-based ART regimens.

Given that there were no relapses among participants with baseline HCV RNA <6.9 log IU/mL, the researchers concluded, "acutely HCV-infected patients with a higher viral load should be considered for longer duration of therapy."

Rockstroh noted that although shorter interferon-based treatment works well for acutely infected patients, "unfortunately DAAs don't behave the same way."

He acknowledged that it is still not clear when is the best time to treat people with acute HCV infection. About 25% of all people and 15% of HIV-HCV coinfected people with acute infection will spontaneously clear the virus. Many experts recommend waiting to see if treatment is really needed, but the likelihood of transmitting HCV during this early period can be high.

When considering guidelines for acute hepatitis C treatment, "everything is going to be driven by viral load," Rockstroh predicted.



JK Rockstroh, S Bhagani, RH Hyland, et al. Ledipasvir/Sofosbuvir for 6 Weeks in HIV-Infected Patients With Acute HCV Infection. Conference on Retroviruses and Opportunistic Infections. Boston, February 22-25, 2016. Abstract 154LB.

FDA Approves Harvoni for Hepatitis C Patients with Advanced Liver Disease

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Gilead Sciences sofosbuvir/ledipasvir coformulation (Harvoni) plus ribavirin for genotype 1 chronic hepatitis patients with decompenated liver cirrhosis and for genotype 1 or 4 liver transplant recipients without cirrhosis or with compensated cirrhosis, the company announced this week.


Daclatasvir Plus Asunaprevir Cures Most Genotype 1b Chinese Hepatitis C Patients

An interferon- and ribavirin-free dual combination of Bristol-Myers Squibb's hepatitis C virus (HCV) NS5A inhibitor daclatasvir (Daklinza) and HCV protease inhibitor asunaprevir (Sunvepra) produced sustained response in more than 90% of genotype 1b chronic hepatitis C patients in China, researchers reported at the 25th Conference or the Asian Pacific Association for the Study of the Liver this week in Tokyo. 


FDA Approves Daclatasvir + Sofosbuvir for Hard-to-Treat Hepatitis C Patients

The U.S. Food and Drug Administration (FDA) this month approved an expanded indication for Bristol-Myers Squibb's daclatasvir (Daklinza) and Gilead Sciences sofosbuvir (Sovaldi) for additional patient groups including people with HIV/HCV coinfection, patients with advanced liver cirrhosis, and liver transplant recipients.


Direct-Acting Antivirals Reduce Cryoglobulinemia in People with Hepatitis C

Treatment with direct-acting antivirals not only cures people of hepatitis C, but can also rapidly reduce the severity of one of the most troublesome extra-hepatic manifestations of the disease, a study published in the February edition of Hepatology shows.


AASLD 2015: MiR-122 Inhibitor RG-101 Suppresses Hepatitis C Virus with Single Dose

A single injection of RG-101, an experimental drug that targets the micro RNA miR-122 in liver cells, reduced hepatitis C virus (HCV) levels by more than 4 log in people with HCV genotypes 1, 3, and 4, and 21% of treated patients still had undetectable virus levels 28 weeks after dosing, according to research presented at the AASLD Liver Meeting in November.