Viral Hepatitis Review

Hopkins HIV Report 2006 Mar; 18(2):5

John G. Bartlett, M.D.
Johns Hopkins

Hepatitis B Co-infection

Therapy for hepatitis B virus (HBV) was addressed by Richard Colono with results from a trial of entecavir, a drug with potent anti-HBV activity and no activity against HIV [Colonno R, et al., Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 832]. Consequently, entecavir is an option for co-infected patients where it is used: 1) to treat HBV without treating HIV, 2) as an alternative to tenofovir to combine with lamivudine/ emtricitabine (3TC/FTC), provided at least two additional antiretroviral agents are used as well, or 3) to treat 3TC/FTC-HBV treatment failures. The trial included 50 HIV/HBV-coinfected patients with prior 3TC exposure for HIV therapy, including 48 with baseline HBV resistance to 3TC. At 48 weeks there was a mean reduction in HBV DNA of 4.2 log₁₀ c/mL, and no patient experienced virologic rebound. Two were found to have resistance mutations to entecavir at completion of treatment, but a retrospective analysis showed these mutations were present at baseline. The authors concluded that entecavir (1 mg/day) is effective in treating co-infected patients with 3TC-resistant HBV.

A humbling report from Southwestern concerned the failure of HIV care providers to apply the same care standards to HBV that they do to for HIV in co-infected patients [Jain M, et al. Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 837]. In review of 362 such patients, the median number of viral load measurements in the first year following initiation of HAART was 3 for HIV and 0 for HBV, and only 16% had measurements of HBV DNA levels or HBeAg at baseline. Only 31% of those positive for HBsAg had ultrasound of the liver; of the 115 who did have an ultrasound, 63 (55%) were abnormal. The authors concluded that adherence to standards of care by their clinicians was good for HIV, but not for HBV.

Hepatitis C Co-infection

A review of treatment success in hepatitis C (HCV)/HIV-co-infected patients at the Johns Hopkins Moore Clinic was particularly practical and important [Mehta S, et al. Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 884]. This HIV clinic has a dedicated unit for the management of viral hepatitis, and the purpose of the study was to determine the number of coinfected patients who achieved an HCV cure (sustained viral suppression). A total of 845 patients were followed for over 2 years and were considered eligible for HCV treatment referral. The sequential analysis was: 277/845 (33%) were referred, 185/277 (67%) kept the appointment, 125/185 (68%) completed medical evaluation, 81/125 (65%) were considered eligible for treatment, 29/81 (36%) started therapy, and 6/29 (21%) achieved a sustained viral response. Thus, in a clinic that offers specialty care for both HIV and HCV, only 3% were treated for HCV and less than 1% had a sustained viral response. These discouraging results may reflect the realities of both the efficacy of current treatment for HCV infection in patients with predominantly genotype 1 infection, and also of the challenges of completing therapy in this patient population.

Other HCV Treatment News

• HCV RNA at 4 weeks may be useful tool for adjusting duration of therapy genotype 2 or 3 [Crespo M, et al. Abstract 81]. The authors found that among 20 patients with a HCV RNA at 4 weeks <100 IU/mL, 18 (90%) had a sustained viral response compared to 6 (37.5%) of 16 patients with a 4-week HCV RNA >100 IU/mL.
• Longer treatment with peginterferon + ribavirin for HIV-co-infected patients with HCV genotype 1 did not increase the likelihood of a sustained virologic response [Uriel A, et al. Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 854]. The trial included 61 patients with undetectable virus at 24 weeks who were randomized to complete a standard 48-week course or a 72-week course. Among all patients with genotype 1a, sustained viral response was achieved in only 18/141 (13%), and 53% of those randomized at 24 weeks did not complete treatment. The longer course added no benefit, but most patients could not complete it, leading the investigators to conclude longer courses are unrealistic.
• High doses of peginterferon failed to improve outcome in an open-label trial from the Netherlands [Ruys T, et al. Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 852]. Twenty-three patients were randomized to standard treatment (peginterferon 2b 1.5 mcg/kg/wk) or high dose peginterferon (3.0 mcg/kg/wk x 4 wks, then 2.0 mcg/kg/wk x 4 weeks, then standard dose for 40 weeks). All patients received ribavirin 1000-1200 mg/day and were treated 48 weeks. Sustained viral responses were achieved in only 3/10 (30%) in the standard arm and 5/13 (38%) of the high induction dose arm. The high dose group also had more neuropsychiatric complications.
• New drugs for HCV include VX 950 (Vertex) and SCH5030304 (Schering), two protease inhibitors that show significant promise. Kwang from Vertex reviewed a trial in which 12 patients with HCV co-infection who failed peginterferon + ribavirin were treated with these two drugs plus VX 950 (750 mg bid) [Kwong A, Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 172]. Sustained viral responses were achieved in all 12.

2006-03-10
HHR-2006-03-03

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