Jpn.J.Infect.Dis. 52, 1999

Laboratory and Epidemiology Communications

Status of Anti HIV-1 Chemotherapy in Japan

Tsuyoshi Oishi, Wataru Sugiura*, Masakazu Matsuda, Hanae Abumi, Aiko Okano, Kaneo Yamada¹, Mitsuru Koike¹, Masashi Taki², Masaaki Ishikawa³, Takuma Miura⁴, Katsuyuki Fukutake⁵, Kengo Gouchi⁶, Atsushi Ajisawa⁷, Aikichi Iwamoto⁸, Hideji Hanabusa⁹, Junichi Mimaya¹⁰, Junki Takamatsu¹¹, Noboru Takata¹², Eizo Kakishita¹³, Satoshi Higasa¹³, Akira Yoshioka¹⁴, Seizaburou Kashiwagi¹⁵, Akira Shirahata¹⁶, and Yoshiyuki Nagai

AIDS Research Center, National Institute of Infectious Diseases, Gakuen 4-7-1, Musashimurayama-shi, Tokyo, ¹Institute of Medical Science, St. Marianna University School of Medicine, Sugao 2-6-1, Miyamae-ku, Kawasaki-shi, Kanagawa, ²Department of Pediatrics, St. Marianna University School of Medicine, Sugao 2-6-1, Miyamae-ku, Kawasaki-shi, Kanagawa, ³Third Department of Internal Medicine, Tohoku University, School of Medicine, Seiryo-cho 1-1, Aoba-ku, Sendai-shi, Miyagi, ⁴Department of Pediatrics, Haga Red Cross Hospital, Dai-machi 2461, Mooka-shi, Tochigi, ⁵Department of Clinical Pathology, Tokyo Medical University, Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, ⁶Department of Internal Medicine, Teikyo University, School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, ⁷Department of Infectious Diseases, Tokyo Metropolitan Komagome Hospital, Honkomagome 3-18-22,, Bunkyo-ku, Tokyo, ⁸Department of Infectious Diseases, Institute of Medical Science, The University of Tokyo, Shiroganedai 4-6-1, Minato-ku, Tokyo, ⁹Department of Hematology, Ogikubo Hospital, Imagawa 3-1-24, Suginami-ku, Tokyo, ¹⁰Division of Hematology and Oncology, Children's Hospital of Shizuoka Prefecture, Urushiyama 860, Shizuoka-shi, Shizuoka, ¹¹Division of Blood Transfusion, Nagoya University Hospital, Tsurumai 65, Syowa-ku, Nagoya-shi, Aichi, ¹²Division of Blood Transfusion Services, Hiroshima University Medical Hospital, Kasumi 1-2-3, Minami-ku, Hiroshima-shi, Hiroshima, ¹³Second Department of Internal Medicine, Hyogo College of Medicine, Mukogawa-cho 1-1, Nishinomiya-shi, Hyogo, ¹⁴Department of Pediatrics, Nara Medical College, Shijo-cho 840, Kashihara-shi, Nara, ¹⁵Department of General of Medicine, Kyushu University Hospital, Maidashi 3-1-1, Higashi-ku, Fukuoka, ¹⁶Department of Pediatrics, University of Occupational and Environmental Health, Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-shi, Fukuoka.　

Communicated by Hiroshi Yoshikura

(Accepted May 7, 1999)

The year 1997 was a memorable one for anti-HIV-1 treatment in Japan. Three protease inhibitors (PIs), Saquinavir, Ritonavir and Indinavir, were approved and became available for clinical use. Treatment with a PI in combination with two reverse transcriptase inhibitors (RTIs), so called highly active anti-retroviral therapy (HAART), has been reported to block virus replication almost completely and restore CD4-positive cell count(1,2). Two years have past since the approval of PI. We analyzed treatment protocols of 809 cases of HIV-1 infected patients, and report here the current status of ongoing anti-HIV-1 chemotherapy in 16 hospitals in Japan.

Among 809 cases, 446 cases (55.1%) were receiving HAART and 363 cases mono or double therapy (Fig. 1-A). Among the cases currently receiving HAART, 301 cases had been treated with mono or double therapy before HAART (experienced group), while 145 patients were never treated with any HIV-1 drugs before HAART (naive group). Though HAART is now accepted as a standard regimen of HIV-1 treatment in Japan, not all the patients who received HAART responded to the therapy favorably. Low adherence of the drugs and the emergence of drug-resistant mutant viruses could have caused the treatment failure. Figures 1-B and -C respectively show the frequencies of the successful cases in the naive and the experienced groups. The definition of "the success of the therapy" here was a reduction of the plasma viral load below a detectable level (less than 400 copies/ml). Eighty-seven (60.0%) out of 145 naive cases and 150 (49.8%) out of 301 experienced cases were considered successful at the time of the investigation. The frequency of the successful cases was only slightly higher in the naive group compared to the experienced group. Figure 2 shows the histogram of the duration of undetectable level of viral RNA among the 237 successfully treated cases. Among the 237 cases which responded to the therapy, 124 cases maintained undetectable levels of the virus RNA for more than a year.

HAART is now recognized as the standard regimen of anti-HIV chemotherapy. Its success rate was 50 to 60% irrespective of previous therapies. Improvement of the regimen in areas such as administration schedules, more effective combination of the drugs, etc. should be further pursued.

This work was supported by the Organization of Pharmaceutical Safety and Research (OPSR) of Japan.

REFERENCES

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2. Hammer, S.M., Squires, K.E., Hughes, M.D., Grimes, J.M., Demeter, L.M., Currier, J.S. Eron, J.J., Jr., Feinberg, J.E., Balfour, H.H., Jr., Deyton, L.R., Chodakewitz, J.A. and Fischl, M.A. (1997): A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N. Engl. J. Med., 337, 725-733.

* Corresponding author: E-mail:wsugiura@nih.go.jp, Fax:+81-42-561-7746

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