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Discuss preferred therapies for initial treatment of patients with genotype 1a or 1b chronic HCV. Key Studies to Support Recommendations for Genotype 1: The following key studies support the recommendations for treatment of patients with chronic hepatitis C and genotype 1 infection who are treatment naive or who have previously received treatment and had virologic relapse with a regimen that included peginterferon and ribavirin. A1444040: The AI444040 trial had multiple treatment arms of daclatasvir and sofosbuvir, with or without ribavirin. ION-3: In this phase 3 trial, treatment-naive patients with genotype 1 HCV received fixed dose combination of ledipasvir-sofosbuvir, with or without ribavirin, for 8 or 12 weeks. SAPPHIRE-I: This phase 3 trial enrolled treatment-naive patients with genotype 1 HCV to receive a 12-week treatment course with ombitasvir-paritaprevir-ritonavir and dasabuvir plus ribavirin. PEARL-III and PEARL-IV: These phase 3 trials enrolled treatment-naive patients to receive a 12-week treatment course with ombitasvir-paritaprevir-ritonavir and dasabuvir with or without ribavirin. TURQUOISE-II: This phase 3 trial enrolled treatment-naive and treatment-experienced patients with genotype 1 chronic HCV, including those with compensated cirrhosis, to receive a 12- or 24-week treatment course with ombitasvir-paritaprevir-ritonavir and dasabuvir plus ribavirin. OPTIMIST-1: In this randomized, phase 3, open-label trial, investigators compared an 8-week versus 12-week regimen of simeprevir plus sofosbuvir in HCV genotype 1, treatment-naive and treatment-experienced patients without cirrhosis.
OPTIMIST-2: This randomized, phase 3, open-label, single-arm trial examined the effectiveness and safety of a 12-week treatment course with simeprevir plus sofosbuvir in treatment-naive or treatment experienced patients with chronic HCV genotype 1 and compensated cirrhosis.
Factors to Consider Prior to Choosing Treatment Regimen: For patients with chronic hepatitis C genotype 1 infection who have treatment experience, the primary factors that determine the recommended regimen and duration of treatment are presence of cirrhosis, the prior regimen used when treatment failure occurred, and in some instances, genotype 1 subtype. Worldwide, an estimated 185 million people have been infected with the hepatitis C virus (HCV). The "new generation" of drugs for HCV that are now available in the United States cost $84,000 (sofosbuvir) and $66,000 (simeprevir) per person, for a 12-week course of treatment (6) (see the figure). Over the past 15 years, licensing to manufacturers of generics, economies of scale, and improvements in manufacturing processes have driven the cost of antiretroviral (ARV) treatment for HIV infection down by more than 99%, with standard HIV treatment now costing as little as $60 per patient per year, using the same standard of care that patients receive in the richest nations (11). Creating a new funding mechanism for poor nations is difficult in the current economic climate, but HIV has left a legacy of structures ready to adapt to hepatitis C to complement government and private-sector efforts. Enrollment included treatment-naive and treatment-experienced patients with genotype 1 and treatment-naive with genotype 2 or 3. Overall, treatment with simeprevir plus sofosbuvir resulted in an SVR12 in 86 (83%) of 103 patients.

This price could not have been imagined when effective HIV treatment was introduced at over $10,000 per patient per year in the late 1990s (12). In many of the poorest countries, there are few or no programs to treat HCV, so new funding streams are needed to support the scale-up of treatment as part of comprehensive control and prevention programs. UNITAID, the United Nations agency created in 2006 to overcome market barriers for treatments of HIV, tuberculosis, and malaria, recently announced its first funding for hepatitis C, with an aim of reducing treatment costs to $500 to $1000 per patient (14). This has been an inspiring medical success story which need not stand alone but can be repeated, even more rapidly, for hepatitis C. With most regimens, the baseline HCV RNA value does not influence the treatment choice or duration. In Cohort 2, 40 (46%) of 87 patients were treatment naive and had advanced fibrosis (Metavir scores of F3-F4).
In the treatment-naive patients, the SVR12 rates with the 12-week regimen were superior to the 8-week regimen (97% versus 85%).
Ultimately, the choice of a particular regimen will be influenced by cost, insurance coverage, pill burden, potential drug interactions, use of ribavirin, relevant comorbid conditions, and the patient and provider preferences.
New treatments are available that can cure over 90% of people with HCV within 12 weeks (5).
However, these treatments could be manufactured for as little as $78 to $166 per person for a 12-week course of two drugs, according to our recent analysis (5). For example, one of the most promising early combination treatments for hepatitis C-sofosbuvir and daclatasvir-cured over 90% of patients after 12 weeks (13). Such funding needs to be matched with commitments from pharmaceutical companies in wealthy nations so that new-generation drugs can be made at minimal cost. It plans to scale up treatment through a multinational group of HIV programs run by Medicins Sans Frontieres, the international medical humanitarian organization. Historically, genotype 1 hepatitis C has been considered the most difficult to treat hepatitis C genotype. For the treatment-naive genotype 1 patients treated with a 12-week course of daclatasvir plus sofosbuvir, with or without ribavirin, 80 (98%) of 82 achieved an SVR12. In the treatment-naive patients, the SVR12 rates were greater than 90% and similar with or without ribavirin and regardless of whether the patient received 12 or 24 weeks of therapy.

This study demonstrates the all-oral 12-week regimen of simeprevir plus sofosbuvir is highly effective and well tolerated in treatment-naive and treatment-experienced HCV genotype 1 patients without cirrhosis. In the combined data for treatment-naive and treatment-experienced patients wtih genotype 1a infection, the SVR12 rates were higher in the group without the baseline Q80K mutation than those with the baseline Q80K mutation (92% versus 74%). It is important to note that pre-treatment resistance testing is now recommmended in cirrhotic patients who experienced treatment failure with a prior regimen that included any NS5a inhibitor, including daclatasvir plus sofosbuvir, ledipasvir-sofosbuvir, or ombitasvir-paritaprevir-ritonavir plus dasabuvir. Efforts have begun by the manufacturer to make sofosbuvir affordable in some low-income countries like Egypt ($1000), but no country is yet able to access this drug at a cost that is close to the predicted minimum production price. Companies can only start production of generic versions 12 to 15 years from now, when an estimated 6 to 7.5 million more people will have died from hepatitis C if untreated, given current death rates and given that the epidemic would continue to grow.
With the invention of a simple and effective therapy (ARVs), a competitive market was created for companies to mass produce generics, which, in turn, lowered costs and made treatment affordable. Thus, pharmaceutical companies should allow generic companies to mass produce these treatments for use in low-income countries at a cost close to the cost of production, with a small royalty paid back to the pharmaceutical companies. This study demonstrates that the all-oral 12-week regimen of simeprevir plus sofosbuvir is generally effective in treatment-naive patients with cirrhosis and HCV genotype 1, except that patients with genotype 1a and the baseline Q80K mutation have lower SVR rates. The retreatment of genotype 1 patients with decompensated cirrhosis, renal impairment, HIV coinfection, acute hepatitis C infection, or post-liver transplantation is not addressed here.
There are now more than 10 million people receiving treatment for HIV in poor countries, at a very low price. The current high prices of new hepatitis C treatments will place a strain on all healthcare systems. In some countries, reductions in the price of HIV-1 treatments were only achieved after long legal battles with pharmaceutical companies. In the United States, Congress is investigating the pricing of sofosbuvir, including the methods used to establish the cost. All of these agents, except for daclatasvir, are FDA approved for the treatment of genotype 1 HCV.

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