Researchers find HCV treatment uptake declined over time among HIV/HCV coinfection

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In the Swiss HIV Cohort Study, researchers found that hepatitis C virus infection treatment uptake over the last 13 years has been low and many patients co-infected with HIV and hepatitis C remained untreated since 2013.

“The Swiss HIV Cohort Study offers an ideal platform to study the natural course of HCV infection and long-term influence of HCV treatments in a nationwide representative population of HIV-infected patients,” the researchers wrote in the Journal of Hepatology. “We aimed to assess the changes in epidemiology, clinical course and therapy of HCV infection between 2001 and 2013 and to characterize the population who remains eligible for the new HCV treatment options by the end of 2013.”

Of 12,401 patients, 17% were positive for HCV RNA (n = 2,107) and 23.8% were seropositive for HCV. Thirty-percent of the HCV RNA-positive patients (n = 636) began therapy with an incidence of 5.8 per 100 person-years (95% CI, 5.3-6.2). Of the patients treated with pegylated interferon and ribavirin, 50% achieved sustained virologic response, which represented 15% of all participants with replicating HCV infection, according to the research. Also, of the 636 treated patients, 11% were treated twice and 2% were treated at least 3 times.

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EASL 2015: Daclatasvir-sofosbuvir treatment highly effective in patients with HCV and HIV co-infection

Phase III results revealed today at The International Liver Congress™ 2015 show that once-daily treatment with daclatasvir (DCV) plus sofosbuvir (SOF) resulted in an overall 97% sustained virologic response (SVR) at 12 weeks post-treatment in patients with hepatitis C virus (HCV) and HIV co-infection, including cirrhotic patients.

HIV co-infection more than triples the risk of hepatitis C-related liver disease, liver failure and liver-related death. Co-infection can also complicate the management of HIV infection.

In the ALLY-2 randomised, open-label study, the combination of DCV+SOF was well tolerated and effective across the four different genotypes. Importantly, due to their limited pharmacokinetic interactions with other agents, DCV+SOF was able to work effectively across a broad range of concomitant combination antiretroviral therapy (cART) regimens without compromising HIV virologic control (98% of patients were on cART).

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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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Sofosbuvir/ledipasvir raises some antiretroviral levels in HIV/HCV coinfected people

HIV/HCV coinfected people who take sofosbuvir/ledipasvir (Harvoni) to treat hepatitis C along with boosted protease inhibitor antiretroviral regimens may experience changes in drugs levels, but these are mostly not considered clinically relevant, according to a drug-drug interaction study presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) last month in Seattle. However, data on the safety and efficacy of combining sofosbuvir/ledipasvir with boosted protease inhibitors during treatment are lacking, and increased tenofovir exposure may be a concern.

The advent of interferon-free direct-acting antiviral regimens has brought about a revolution in treatment for chronic hepatitis C virus (HCV) infection, including for patients who have traditionally been considered 'difficult to treat', such as those with HIV/HCV coinfection. Clinical trials have seen cure rates for coinfected people equal to those for patients with HCV alone, and current treatment guidelines and product labels indicate that HIV-positive patients can be treated with the same recommended regimens as HIV-negative ones, taking into account potential interactions with antiretroviral therapy (ART).

Polina German of Gilead Sciences reported findings from a phase 1 study to evaluate interactions between sofosbuvir/ledipasvir and ART regimens containing ritonavir-boosted atazanavir (Reyataz) or darunavir (Prezista) plus tenofovir/emtricitabine (Truvada) in healthy HIV-negative volunteers.

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Women for Positive Action Launch a New Educational Tool on 'Hepatitis and Coinfection in Women Living With HIV' to Celebrate International Women's Day 2015

LONDON, March 6, 2015 /PRNewswire/ --

To mark International Women's Day (March 8, 2015), Women for Positive Action has launched a practical and informative new educational tool entitled 'Hepatitis and coinfection in women living with HIV'. Led by a global, multidisciplinary group of experts, Women for Positive Action is committed to addressing the specific concerns of women living with HIV. This new tool (download here) offers empowering information to coinfected women and practical guidance to those involved in their care.

In coinfected individuals immunosuppression exerts deleterious effects by greatly accelerating the occurrence of cirrhosis and liver cancer.^[1] The complexity of treatment, the double stigma of coinfection and the perceived risk of side effects are all known to adversely affect the emotional wellbeing of patients,^[2] and this can be compounded in many women struggling to balance work and family commitments.

"I have been struggling with HIV for years and when I finally got stabilised on HAART, I feared I would die from my liver because of hepatitis C. I failed HCV treatment two times and had to cope with unbearable side effects. Right when I was desperate that I would die from cirrhosis, I got cured thanks to the new HCV drugs - it was like being born a second time." A woman recently cured from HCV.

The HCV landscape has changed dramatically in recent years with the availability of treatments that cure a large proportion of patients^[3]; but too often women from high risk groups are left behind. This tailored educational tool will help support those caring for coinfected women to provide practical guidance and respond to their needs on aspects such as treatment, emotional wellbeing, access to care and pregnancy planning. This tool also aims to raise awareness of women and their inclusion in research and access to care in this new era of HCV treatments.

Women for Positive Action is committed to exploring and addressing the challenges faced by women living with HIV and those involved in their care. For more information visit the website, http://www.womenforpositiveaction.org and keep up to date with activities through Twitter @WFPA_HIV.

Notes to Editor 

130-150 million people globally have chronic HCV infection and up to 500,000 people die each year from HCV-related liver diseases.^[4] Five million individuals are estimated to have HIV/HCV coinfection^[4] so approximately 25-30% of those with HIV are coinfected with HCV.^[5] Coinfection affects a large proportion of women living with HIV.^[6] HCV is a rapidly evolving treatment area with a number of new therapies now available.  

Visit http://www.womenforpositiveaction.org for information about ongoing projects. Women for Positive Action is an educational program funded by AbbVie. All content is independently generated by the Women for Positive Action faculty experts reflecting their knowledge and opinions.

References  

1. WHO. Hepatitis C Fact Sheet No.164, April 2014.
2. Pereira M et al. AIDS Care 2014;26:56-64.
3. Wendt A & Bourlière M. Ther Adv Infect Dis 2013;1:191-208.
4. Operskalski E et al. Curr HIV/AIDS Rep 2011;8:12-22.
5. Alter MJ. J Hepatol 2006;44:S6-9.
6. Tremeau-Bravard A et al. Afr Health Sci 2012;12:312-317.

For further information please contact the Women for Positive Action Secretariat:
Email: WFPA@litmus-mme.com
Tel: +44-(0)20-7632-1924
Twitter: @WFPA_HIV

SOURCE Women for Positive Action

Press Release Source: http://www.prnewswire.com/news-releases/women-for-positive-action-launch-a-new-educational-tool-on-hepatitis-and-coinfection-in-women-living-with-hiv-to-celebrate-international-womens-day-2015-295303061.html 

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

SVR rates up with new regimens for HCV and HIV coinfection

For patients with hepatitis C virus genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

(HealthDay)—For patients with hepatitis C virus (HCV) genotype 1 and HIV coinfection, new regimens are effective and correlate with high rates of sustained virologic response (SVR) after treatment, according to two studies published online Feb. 23 in the Journal of the American Medical Association.

Mark S. Sulkowski, M.D., from Johns Hopkins University in Baltimore, and colleagues conducted an open-label trial at 17 sites in the United States and Puerto Rico. Sixty-three patients with HCV genotype 1 and HIV-1 coinfection received the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir), dasabuvir, and ribavirin for 12 or 24 weeks. The researchers found that 94 and 91 percent, respectively, of those receiving 12 or 24 weeks of 3D and ribavirin achieved SVR at post-treatment week 12 (SVR12). Fatigue, insomnia, nausea, and headache were the most common treatment-emergent adverse events (48, 19, 18, and 16 percent, respectively).

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Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) Published Online in JAMA; Sub-analyses to be Presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)

- In adult patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1), TURQUOISE-I, using VIEKIRA PAK with ribavirin (RBV), demonstrated sustained virologic response rates 12 weeks post-treatment (SVR12) of 94 percent with 12 weeks of treatment and 91 percent with 24 weeks of treatment, respectively

 - TURQUOISE-I results published online today in The Journal of the American Medical Association (JAMA) - 

Additional sub-analyses of TURQUOISE-I data to be presented this week at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)

NORTH CHICAGO, Ill., Feb. 23, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that results from part one of the Phase 2 portion of its Phase2/3 open-label study, TURQUOISE-I, in genotype 1 chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection were published online in The Journal of the American Medical Association (JAMA). Additional sub-analyses also will be presented in both oral and poster presentations on Feb. 26, at the Annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Wash.

As published today in JAMA, and originally presented at The Liver Meeting® 2014, the TURQUOISE-I study showed patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1 receiving VIEKIRA PAK™ and ribavirin (RBV) for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR₁₂) of 94 percent (n=29/31) and 91 percent (n=29/32), respectively. The SVR₁₂ rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection.

"It is common for people to live with both GT1 chronic HCV and HIV, but data supporting treatment of chronic HCV in these co-infected patients have been limited," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "TURQUOISE-I is one of the few dedicated studies looking specifically at this historically difficult-to-treat population and we are proud to offer the HCV community an important new treatment option."

VIEKIRA PAK is contraindicated with efavirenz (Sustiva) because co-administration is poorly tolerated and results in liver enzyme elevations. The ritonavir component of VIEKIRA PAK is an HIV-1 protease inhibitor and can select for HIV-1 protease inhibitor resistance. To reduce this risk, HCV/HIV-1 co-infected patients should also be on a suppressive antiretroviral (ART) drug regimen. The most common adverse events occurring in at least 10 percent of patients in TURQUOISE-I were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), itching (13%), cough (11%), irritability (10%), and yellowing of the eyes (10%).

Sub-analyses of these data will be presented later this week at CROI in oral and poster presentations:

• High SVR Regardless of Time to Suppression with Paritaprevir/r/Ombitasvir & Dasabuvir + RBV Oral Presentation #147
  February 26, 2015, 10:30-10:45 p.m. PST, Room 6AB 
  Analysis of time to HCV suppression in HCV/HIV co-infected patients in TURQUOISE-I
• Hematologic Analysis of Paritaprevir/r/Ombitasvir and Dasabuvir + RBV in TURQUOISE-I Poster #691
  February 26, 2015, 2:30-4 p.m. PST, Poster Hall 
  In this analysis of the TURQUOISE-I study, certain laboratory values in patients taking paritaprevir/r/ombitasvir and dasabuvir with RBV were examined, including hemoglobin, CD4+ T cells, and lymphocyte count

About TURQUOISE-I  TURQUOISE-I is an ongoing Phase 2/3, multi-center, randomized, open-label study evaluating the efficacy and safety of VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily) with RBV (weight based dosing of 1000 mg or 1200 mg per day divided twice daily) for 12 or 24 weeks in adult patients with chronic GT1 HCV infection with or without compensated liver cirrhosis who are also infected with HIV-1.

Study patients were either new to therapy (treatment-naïve) or had failed previous treatment with pegylated interferon and RBV (treatment-experienced), had a stable immune status (CD4+ counts of ≥200 cells/mm³ or CD4+ % ≥14%). Patients were on a stable HIV-1 ART regimen that included tenofovir disoproxil fumarate plus emtricitabine or lamivudine, administered with ritonavir-boosted atazanavir or raltegravir. Patients on atazanavir stopped the ritonavir component of their HIV-1 ART regimen upon initiating treatment with VIEKIRA PAK + RBV. Atazanavir was taken with the morning dose of VIEKIRA PAK. The ritonavir component of the HIV-1 ART regimen was restarted after completion of treatment with VIEKIRA PAK and RBV. Of the five patients who were non-responders, one experienced virologic failure, one discontinued treatment, one experienced relapse and two patients had evidence of HCV reinfection post-treatment. Based on the results of this study, prescribers should follow the same dosing recommendations for mono-infected patients as outlined in the VIEKIRA PAK prescribing information.

Elevations in total bilirubin were the most common laboratory abnormality, were mainly composed of indirect bilirubin, and were not associated with elevations in commonly measured liver enzymes. Reductions in RBV dose because of anemia or reduced hemoglobin occurred in 10 percent of patients (n=6/63); all six patients achieved SVR₁₂.

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Georgia refuses Hep-C cure for poz guys

News in gay Atlanta of a drug that can eradicate previously incurable Hepatitis-C in 99 percent of cases was tainted last week by the state picking and choosing who can get it, excluding thousands of HIV-positive patients. It’s renewed a clarion call by activists to expand Medicaid.

The 12-week drug regimen known as V-Pak works, but it’s expensive – as much as $80,000 per patient. The National Alliance of State and Territorial AIDS Directors, which includes Georgia, negotiated a discount to about half price, but each state must decide whether or not to offer it under various programs.

In Georgia, that meant Hepatitis C patients under Medicaid will get V-Pak. But HIV-positive people with Hep C on ADAP, the HIV prescription assistance program, can’t. State agencies say they’re hamstrung by the cost to offer life-saving treatment to some and deny it to others, according to WABE.

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