Results of randomized controlled trial on the impact of prolonged combination anti HCV treatment on relapse rate in HIV/HCV coinfected patients with HCVRNA negativization at the end of a 24–48 weeks course of treatment: The ROMANCE study

Puoti, M.; Zanini, Bárbara; Luca, Antonella De; Quinzan, Giampaolo; Allegri, Rossi Beatrice Maria; Bruno, Raffaele; Orani, Anna Maria; Quirino, Tiziana; Santantonio, T.; Pastore, G; Cristini, G; Suter, F.; Cauda, Roberto; Carosi, G.

doi:10.1016/j.dld.2007.12.027

Cited by 3 publications

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“…3). More recent data also suggest that patients infected with genotype 2/3 with low viral loads (<400 000 IU/mL) and mild fibrosis who achieve an undetectable HCV RNA by 4 weeks (rapid virological response) may only need 24 weeks of therapy [13]. Patients with a history of previous HCV therapy who were either nonresponders or relapsed under previous HCV therapy need to be reassessed with regard to a new HVC treatment, optimizing dose and duration as well as providing the best possible supportive therapy.…”

Section: Summary Of Guidelinesmentioning

confidence: 99%

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV‐infected adults

et al. 2008

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Objectives With the decline in HIV‐associated morbidity and mortality following the introduction of highly active antiretroviral therapy (HAART), liver disease has emerged as a major cause of death in HIV/hepatitis B virus (HBV) and HIV/hepatitis C virus (HCV) coinfected persons. Therefore, screening for underlying viral hepatitis coinfection and the provision of management and treatment recommendations for patients with chronic viral hepatitis are of great importance in preventing, as far as possible, the development of liver disease. With the introduction of new agents for the treatment of hepatitis B and increased knowledge of how best to manage hepatitis C, an update of current guidelines for management of HBV and HCV coinfection with HIV is warranted. Summary Clearly, all HIV‐infected patients should be screened for hepatitis A, B and C, taking into account shared pathways of transmission. Patients who are seronegative for hepatitis A and B should be considered for vaccination. In HIV‐infected patients with chronic hepatitis B, the first important differentiation is whether HAART is required or not. In the setting of stable HIV infection, with no need for HAART, several treatment options are available, namely treatment with interferon, early initiation of HAART, or selective non‐HIV active anti‐HBV nucleoside therapy, with the aim of achieving undetectable HBV DNA levels. In most cases, undetectable HBV DNA can only be achieved with combination therapy. With regard to hepatitis C, individualized tailoring of the duration of HCV therapy is advisable, taking into account rapid or delayed virological response. In patients who do not achieve at least a 2 log drop in HCV RNA at week 12, treatment can be terminated because of the low probability of achieving sustained virological response. Overall, with the currently available treatment algorithms, HCV can be eradicated in over 50% of patients. Therefore, HCV therapy should be considered and discussed with the patient if an indication for HCV therapy (elevated liver enzymes, positive HCV RNA and >F1 fibrosis) is present. Conclusions Management of underlying hepatitis B and/or C in patients with HIV infection is of great importance in preventing liver disease‐associated morbidity and mortality.

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Section: Summary Of Guidelinesmentioning

confidence: 99%

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV‐infected adults

et al. 2008

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“…The ROMANCE trial is a multicentre Italian study [26], in which coinfected patients received pegIFN alfa‐2a 180 μg once weekly plus weight adjusted RBV (800 to 1200 mg / day). HCV‐4 patients who had undetectable serum HCV‐RNA at week 48 were randomized to stop treatment at week 52 or continue up to week 72.…”

Section: Methodsmentioning

confidence: 99%

Response to pegylated interferon plus ribavirin in HIV‐infected patients with chronic hepatitis C due to genotype 4

Martín-Carbonero

Puoti

García-Samaniego

et al. 2008

Journal of Viral Hepatitis

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Hepatitis C virus (HCV) genotypes 1 and 4 respond less well to pegylated interferon (pegIFN) plus ribavirin (RBV) therapy. For this reason most studies merge these two genotypes when assessing virological response. However, in most trials the HCV genotype 4 population is rather small, and conclusions are mainly derived from what occurs in HCV-1 patients. All HCV-4 patients coinfected with HIV who received pegIFN plus RBV in two different multicentre studies, PRESCO and ROMANCE, conducted respectively in Spain and Italy, were retrospectively analyzed. Baseline plasma HCV-RNA, proportion of patients with HCV-RNA <10 IU / mL at week 4 (rapid virological response), and HCV-RNA declines >2 logs at week 12 (early virological response, EVR) were all assessed as predictors of sustained virological response (SVR). Overall, 75 patients (60 men) were evaluated. Median age was 40 years and median CD4 count 598 cells / mm(3); 49% had plasma HIV-RNA <50 copies / mL; 71% had elevated liver enzymes and 31% had advanced liver fibrosis (Metavir F3-F4). Median serum HCV-RNA was 5.7 log IU / mL. Rapid virological response was attained by 10 (20%) patients and EVR by 26 (42%). Using intention-to-treat and on-treatment (OT) analyses, SVR was achieved by 21 / 75 (28%) and 21 / 62 (34%) of HCV-4 patients, respectively. In the multivariate analysis (OT), baseline HCV-RNA (OR 0.09 for every log increment; 95% CI: 0.01-0.7) and EVR (OR: 7.08; 95% CI: 1.8-27.2) were significantly and independently associated with SVR. This is the largest series of HIV-infected patients with chronic hepatitis C due to HCV-4 treated with pegIFN plus RBV examined so far and the results show that HCV-4 behaves similarly to HCV-1. Therefore, these patients should be considered as difficult to treat population. Baseline serum HCV-RNA and EVR are the best predictors of SVR in HCV-4 / HIV-coinfected patients.

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“…a negative HCV-RNA at week 4 and a genotype 2 or 3 infection, the overall treatment course may be reduced to 24 weeks. However, this should be only done in patients with a low baseline HCV viral load < 400 000 I.U./ml and only minimal liver fibrosis [55]. All other patients with a genotype 2 or 3 infection should be treated for 48 weeks.…”

Section: Introductionmentioning

confidence: 99%

The treatment of chronic hepatitis C virus infection in HIV co-infection

Vogel

Rockstroh

2009

Eur J Med Res

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Chronic HCV co-infection is present in up to one third of HIV-positive patients in Europe. In recent years, apart from the traditional transmission route of intravenous drug abuse, outbreaks of sexually transmitted acute HCV infections, mainly among HIV-positive men who have sex with men, have contributed to the overall disease burden.Because the natural course of HCV infection is substantially accelerated in HIV-co-infection, end-stage liver disease has become the most frequent cause of non-AIDS related death in this population. Therefore every HIV/HCV co-infected patient should be evaluated for possible anti-HCV therapy with the goal of reaching a sustained virological response and thus cure of hepatitis C infection. The standard of care for the treatment of chronic HCV infection in HIV-infected remains a pegylated interferon in combination with weight-adapted ribavirin.HAART should not be withheld from HCV co-infected patients due to concerns of drug related hepatotoxicity and in patients with reduced CD4-cell counts HAART should be started first. Under pegylated interferon and ribavirin combination therapy drug to drug interactions and cumulated toxicity between nucleoside analogues and anti-HCV therapy may be observed and concomitant didanosine use is contraindicated and zidovudine and stavudine should be avoided if possible.The development of new drugs for the treatment of chronic hepatitis C represents a promising perspective also for HIV positive patients. However, these substances will probably reach clinical routine for HIV patients later than HCV monoinfected patients. Therefore at present waiting for new drugs is not an alternative to a modern pegylated interferon/ribavirin therapy.

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Results of randomized controlled trial on the impact of prolonged combination anti HCV treatment on relapse rate in HIV/HCV coinfected patients with HCVRNA negativization at the end of a 24–48 weeks course of treatment: The ROMANCE study

Cited by 3 publications

References 0 publications

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV‐infected adults

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV‐infected adults

Response to pegylated interferon plus ribavirin in HIV‐infected patients with chronic hepatitis C due to genotype 4

The treatment of chronic hepatitis C virus infection in HIV co-infection

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