India: Mylan to distribute both Sovaldi and Harvoni for HCV

"Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

“Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

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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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Worldwide treatment of hepatitis C could be within sight at the right cost

The FINANCIAL -- Lowering the cost of hepatitis C drugs is possible and key to achieving global access to treatment, according to new research by the University of Liverpool and Imperial College London. 

There are an estimated 185 million people infected with the hepatitis C virus worldwide and 160,000 in Britain. Currently there is no vaccine and, if left untreated, infection can lead to cirrhosis and liver cancer, causing up to 500,000 related deaths globally per year.

Hepatitis C is particularly problematic in low to middle income countries; for example 12 million people are infected in Egypt.

A new and effective generation of direct-acting antiviral drugs (DAAs) has been developed to treat hepatitis C. However, at present these drugs are highly expensive. A 12-week course of the new drug sofosbuvir in the US is priced at as much as $84,000 per person and £55,440 in the UK. The NHS has recently delayed introduction of sofosbuvir due to its high price.

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Canada: With hep C, no province is an island

Let the hepatitis C treatment wars begin.

Prince Edward Island has quietly announced that it will fund a costly new treatment for sufferers of the disease – an announcement with potentially dramatic public-policy repercussions.

For patients infected with hepatitis C virus, a potentially deadly liver disease, this is good news. The new antiviral treatments are the closest thing to miracle drugs that have come along in a long while – with a cure rate in the range of 95 to 97 per cent.

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Why it took so long for the world to start using ‘smart,’ self-destructing syringes

The World Health Organization called Monday for the worldwide use of needle syringes that self-destruct after a single injection.

These "smart" syringes are a response to a problem that medical authorities have recognized for decades -- the frequent reuse of disposable shots. An estimated 25 percent of the 18 billion medical injections performed worldwide each year are done with dirty needles. Unsafe injections cause as many as 1.7 million new hepatitis B infections annually, 315,000 hepatitis C infections and 33,800 HIV infections, according to the World Health Organization. Stopping these infections would be a boon for public health.

“This is a risk we don’t have to be taking,” the WHO's Lisa Hedman said.

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Daclatasvir for hepatitis C: Hint of added benefit in genotype 4

Daclatasvir (trade name Daklinza) has been approved since August 2014 for the treatment of adults with chronic hepatitis C (CHC) infection. According to the dossier assessment conducted by the German Institute for Quality and Efficiency in Health Care (IQWiG) in December 2014, no added benefit could be derived for daclatasvir.

In an addendum, the Institute now examined information subsequently submitted by the drug manufacturer in the commenting procedure: According to the findings, there is a hint of an added benefit for treatment-naive patients with genotype 4. The extent is non-quantifiable, however. The study for patients infected with hepatitis C virus (HCV) of genotype 3, which was presented for the first time, is unsuitable to derive an added benefit.

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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.

Read complete press release here...