Tenofovir Disoproxil Fumarate in Patients with HIV and Lamivudine-Resistant Hepatitis B Virus

Abstract

The new england journal of medicine n engl j med 348;2 www.nejm.org january 9, 2003 170 correspondence Prostatectomy or Watchful Waiting in Prostate Cancer to the editor: In their article comparing prostatectomy with watchful waiting, Holmberg et al. (Sept. 12 issue) 1 present their analysis according to the intention-to-treat principle, but the true treatment effect might be larger than that observed because of noncompliance with the protocol. 2 Presentation of information on the outcome in the participants who did not comply with the protocol and an additional per-protocol analysis could give more insight into the real treatment effect.In addition, the authors report a statistically significant difference between the two groups in terms of distant metastases. However, outside of the protocol, untreated men might undergo a search for metastases more often than treated men. Such a difference could have serious implications for the conclusions drawn by the authors.

Antiviral Effects of Lamivudine, Emtricitabine, Adefovir Dipivoxil, and Tenofovir Disoproxil Fumarate Administered Orally Alone and in Combination to Woodchucks with Chronic Woodchuck Hepatitis Virus Infection

“…A similar decrease in serum HBV DNA of 3.5 and 3.9 log 10 genome equivalents/ml was demonstrated in two other studies after 48 weeks of treatment with ADV (20,51). Tenofovir disoproxil fumarate (TDF), a nucleotide analog approved for the therapy of infection with human immunodeficiency virus (HIV), was also effective in HBV-infected patients who developed 3TC resistance (5,7,43,45,50,59,61,63). Treatment with TDF for 24 to 71 weeks in HIV-coinfected patients demonstrated that HBV DNA concentrations decreased by approximately 4 to 5 log 10 genome equivalents/ml on average (5,18,31,43,45,50,62,63).…”

Reduced Hepatitis B Virus (HBV)-Specific CD4+T-Cell Responses in Human Immunodeficiency Virus Type 1-HBV-Coinfected Individuals Receiving HBV-Active Antiretroviral Therapy

“…Long-term lamivudine therapy (more than 100 weeks) leads to HBeAg seroconversion in 27% of individuals but has also been associated with the frequent development of drug resistance (39,40). Other nucleotide RTI, such as adefovir [9-(2-phosphonylmethoxyethyl)adenine] and tenofovir [9-(R)-(2-phosphonyl-methoxypropyl)adenine], and the nucleoside RTI entecavir (formerly BMS-200475, a carbocyclic 2Ј-deoxyguanosine analog) have also been shown to be effective against HBV (1,6,23). Tenofovir is often used in combination with lamivudine for effective treatment of HBV in HIV-1-infected individuals, as both agents are active against HIV-1 as well as HBV.…”

Treatment outcomes in a cohort of patients with chronic hepatitis B and human immunodeficiency virus co-infection in Mumbai, India

“…These results are similar to those reported in the literature from studies conducted in healthcare settings that were not resource-limited. [10][11][12][13][14][15][16] The TDF/lamivudine-based treatment was adequately effective against HIV replication. Although a large proportion of patients had undetectable HIV RNA, especially HBeA − patients, one-third of the patients studied were not successfully treated.…”

“…TDF anti-HBV efficacy in HIV-co-infected patients has been reported only in relatively small studies with relatively short durations of therapy. [10][11][12][13][14][15][16] Recommendations for the treatment of HBV in HIV co-infected patients are derived from what is known about the treatment of HBV monoinfected patients, and from the limited data available in HBV/HIV co-infected patients. 9 The most recent WHO recommendation regarding antiretroviral therapy (ART) for HBV/HIV co-infection is based on a limited and questionable body of evidence, and the panel that issued the guideline was able to identify only one randomized controlled trial on TDF effectiveness in HBV/HIV co-infection.…”