End-stage liver disease is a concern for people with HIV and hepatitis B or C co-infection

People with HIV and hepatitis B or C virus co-infection are more likely to progress to end-stage liver disease (ESLD), or liver failure, than those with HIV alone, and individuals triply infected with all three viruses face the greatest risk, according to study findings presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2015) in Seattle, USA.

Due to overlapping transmission routes, many people with HIV also have hepatitis B virus (HBV), hepatitis C virus (HCV) or both. Over years or decades, chronic hepatitis B or C can cause serious liver disease including cirrhosis, liver cancer, and potentially liver failure and the need for a liver transplant. In addition to viral hepatitis, other factors such as drug toxicity and heavy alcohol consumption can also contribute to serious liver damage.

Prior research has shown that HBV- and HCV-related liver disease progression is more rapid and possibly more severe in people with HIV. Since the advent of effective antiretroviral treatment (ART), as fewer people with HIV succumbed to opportunistic infections and other AIDS complications, liver disease has become a leading cause of morbidity and mortality in this population.

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Hepatitis C a focus at CROI

New interferon-free treatment can cure nearly 100 percent of HIV-positive people coinfected with hepatitis C virus, researchers reported at the recent 2015 Conference on Retroviruses and Opportunistic Infections in Seattle. But another study showed that delaying treatment results in a higher risk of liver-related complications and death even after being cured.

Two studies presented at the conference showed that HIV/HCV coinfected people can expect the same high cure rates as HIV-negative people using recently or soon-to-be approved antivirals.

Susanna Naggie from Duke Clinical Research Institute presented results from ION-4, a trial evaluating Gilead Science's HCV polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir – the drugs in the Harvoni coformulation approved last October. The study enrolled 335 coinfected participants, mostly with HCV genotype 1 (the most common type in the U.S.).

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Deferring hepatitis C treatment can lead to liver cancer and death, despite cure

HIV/HCV coinfected people who delay hepatitis C treatment remain at risk for liver failure, hepatocellular carcinoma and liver-related death even after being cured – with outcomes worsening the longer it is put off  – indicating that treatment should not be deferred until advanced disease, according to a presentation at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) last week in Seattle. Treating only after progression to cirrhosis increased the risk of liver-related death by more than five-fold and the duration of infectiousness by four-fold.

Over years or decades chronic hepatitis C virus (HCV) infection can lead to advanced liver disease including cirrhosis (scarring), hepatocellular carcinoma (HCC; a type of primary liver cancer) and end-stage liver failure. People with HIV/HCV coinfection experience faster disease progression, on average, than those with HCV alone. Successful hepatitis C treatment reduces - but does not eliminate - the risk.

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Combos Cure HCV in Almost All With HIV Co-infection

Just 12 weeks of treatment eliminated hepatitis C virus in HIV patients.

SEATTLE -- Two drug combinations aimed at hepatitis C (HCV) yielded almost perfect cure rates in patients also infected with HIV, researchers reported here at the 2015 Conference on Retroviruses and Opportunistic Infections.

When the drugs were given for 12 weeks, 96% to 98% of patients had undetectable HCV 12 weeks after the end of therapy -- the so-called SVR₁₂, which is regarded as a cure.

The only blot on the horizon was a 76% SVR₁₂ rate when the combination of daclatasvir and sofosbuvir (Sovaldi) was given for just 8 weeks, reported David Wyles, MD, of the University of California San Diego.

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Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV

– 96 Percent SVR12 Rate for Hepatitis C Genotypes 1 and 4 Among HIV-infected Patients on Antiretroviral Therapy – 

SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni^® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data were presented in a late-breaker oral session (Session 152LB) at the 22^nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie, MD, MHS, Director of Infectious Diseases Research at Duke Clinical Research Institute and Principal Investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”

ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla^®), raltegravir or rilpivirine (Complera^®).

SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. No patients discontinued Harvoni due to an adverse event (AE). Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. The most common AEs reported were headache (25 percent), fatigue (21 percent) and diarrhea (11 percent).

Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. Based on the ION-4 trial results, Gilead plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Harvoni to include the results from this study in the U.S. label. Harvoni received marketing authorization in Europe in November 2014, where data from a small study in HIV-HCV co-infected patients (ERADICATE) are included in the prescribing information. -

See more at: http://gilead.com/news/press-releases/2015/2/gilead-announces-svr12-rates-from-phase-3-study-evaluating-harvoni-for-the-treatment-of-chronic-hepatitis-c-in-patients-coinfected-with-hiv#sthash.MHNmiL6v.dpuf